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At least 19 recordsLinked to original sources
PubMed1992

Validity issues in split-mouth trials.

The main purpose of the split-mouth design is to remove all components related to differences between subjects from the treatment comparisons. By making within-patient comparisons, rather than between-patient comparisons, the error variance (noise) of the experiment can be reduced, thereby obtaining a more powerful statistical test. Unfortunately, comparisons made on a within-patient basis have potential disadvantages. Treatments may have effects on experimental units other than those which they were assigned to (carry-across effects). Such effects cannot be estimated from split-mouth data. Neither can treatment effects be estimated. The estimable parameter in a split-mouth design is the treatment effect plus the sum of all carry-across effects. Unless a priori knowledge indicates that no carry-across effects exist, reported estimates of treatment efficacy are potentially biased. In the design of split-mouth clinical trials, potential gain in precision should be carefully weighed against a potential decrease in validity.

Humans↗
PubMed2026

Clinical performance of two lithium disilicate CAD/CAM materials in posterior Class II inlay restorations: A 48-month randomised split-mouth clinical trial.

OBJECTIVES: To compare the clinical performance of Amber Mill (AM) and IPS e.max CAD (EM) lithium disilicate computer-aided design/computer-aided manufacturing (CAD/CAM) materials in posterior Class II inlay restorations and characterise their baseline properties. METHODS: Thirty-four adults received paired AM and EM posterior Class II inlays (68 restorations) in a triple-blind randomised split-mouth trial followed for 48 months. Restorations were evaluated at baseline and annually using revised World Dental Federation (FDI) criteria, with fracture and retention as the primary endpoint. Baseline characterisation included flexural strength, shear bond strength, translucency parameter, and scanning electron microscopy. McNemar, Wilcoxon signed-rank, Friedman, one-way analysis of variance, Tukey post hoc, and inter-rater agreement analyses were used. RESULTS: At 48 months, 18 paired participants were available for primary analysis. Failures occurred in 2 of 18 AM restorations and in 3 of 18 EM restorations, corresponding to success rates of 88.9% and 83.3%, respectively, with no significant between-material difference (McNemar p = 1.000). No catastrophic bulk ceramic fracture was observed. Secondary FDI scores remained mostly within the clinically acceptable range; marginal staining deteriorated over time in both groups (p < .001) without significant between-material differences. Baseline material testing showed significant material- and translucency-dependent differences in flexural strength, shear bond strength, and translucency. CONCLUSIONS: Within the limitations of the 48-month follow-up and the tested Class II inlay indication, AM showed clinical performance comparable to EM. Observed clinical complications were related to retention or marginal/interface behaviour. CLINICAL SIGNIFICANCE: For posterior Class II lithium disilicate CAD/CAM inlays, medium-term complications were mainly retention/interface-related, suggesting adhesive-interface durability may be as important as baseline ceramic strength.

Humans↗
PubMed2026

Effect of self-activating phthalocyanine gel on palatal donor site healing, inflammatory biomarkers, somatosensory and patient-centered outcomes: a randomized split-mouth clinical trial.

OBJECTIVES: To evaluate effects of self-activating phthalocyanine (PHY) gel on palatal donor site after subepithelial connective tissue graft (SCTG) harvesting, considering clinical outcomes, inflammatory biomarkers, patient-centered outcomes, and quantitative somatosensory changes. MATERIALS AND METHODS: Twenty participants were included in this randomized, crossover, split-mouth clinical trial. Donor sites received topical PHY gel (PHY group-PHYG) and placebo gel (control group-CG). Clinical parameters (residual wound area-RWA, wound epithelialization-WE, residual remodeling area-RRA and tissue thickness-TM) were assessed at baseline, 7, 14, 30, and 60 days. Patient-centered outcomes were recorded during 14 postoperative days and inflammatory biomarkers at 3 and 7 days postoperatively. Mechanical detection threshold (MDT) and mechanical pain threshold (MPT) were evaluated at baseline, 2 months, and 6 months. RESULTS: PHYG and CG exhibited similar clinical outcomes, but PHYG demonstrated superior performance in reducing RRA. Both groups presented positive postoperative progression of patient-centered outcomes. IL-10 levels showed a significant increase in PHYG, suggesting a more favorable anti-inflammatory response. MDT remained stable but, donor sites exhibited transient hypersensitivity (MPT) at 2 months. CONCLUSIONS: PHYG and CG protocols promoted satisfactory healing of palatal donor sites. Most clinical parameters and patient-centered outcomes were similar between groups. The PHYG presented reduced RRA and increased IL-10 levels. Donor sites exhibited transient hypersensitivity, which tended to resolve over time. CLINICAL RELEVANCE: Both postoperative protocols resulted in favorable healing of palatal donor sites following SCTG harvesting, with comparable clinical and patient-centered outcomes. Quantitative sensory testing indicates that hypersensitivity may occur during healing, but sensory function tends to recover progressively.

Humans↗
PubMed2026

Comparison of conventional and micro-surgical techniques for gingival recession using collagen matrix: Randomised controlled split-mouth clinical trial.

BACKGROUND: The present study aimed to determine the effectiveness of the microsurgical approach in treating gingival recession with collagen matrix by comparing it with Conventional surgery in terms of clinical and patient-centered outcomes. METHODS: A total of 29 patients with bilateral gingival recession in the maxillary canine and/or premolar region were selected. After randomisation, bilateral recession sites were grouped into the test group (Microsurgery under 3.5 X magnification) and the control group (Conventional surgery). All the clinical and patient-reported parameters were recorded at baseline, 1, 3 and 6 months. RESULTS: Both groups showed statistically significant differences in terms of reduction in gingival recession height (GRH), gingival recession width (GRW), clinical attachment level gain (CAL gain), increase in keratinized tissue thickness (KTT) and keratinized tissue width (KTW) after 6 months. But intergroup comparison showed no significant difference in terms of clinical parameters. The only significant difference was noted in terms of patient-centred parameters (Patient satisfactory score, Hypersensitivity score, Root aesthetic scores), which favoured the microsurgical group. CONCLUSIONS: Both groups demonstrated comparable clinical improvement; However, Patient-centred parameters were significantly better with the Microsurgical approach. Selection of the surgical approach should balance patient needs with practical considerations like cost, time, and clinician proficiency.

Adult↗
PubMed2026

Cross-kingdom dynamics of the subgingival bacteriome and mycobiome: A pilot study on the effects of a novel HA-H&#x2082;O&#x2082;-Glycine formulation to treat periodontitis.

OBJECTIVES: Traditional periodontal therapy primarily focuses on bacterial biofilm control; however, recent evidence also suggests a critical role for the oral mycobiome. This study evaluated the clinical and ecological impact of a novel mouthwash formulation containing hyaluronic acid (HA), hydrogen peroxide (H2O2), and glycine on periodontal patients METHODS: This prospective, randomized split-mouth trial included 13 adult participants with periodontitis treated with HA-H2O2-glycine formula (BMG0703A) used twice a day for seven days. Subgingival plaque samples were collected from periodontal pocket and healthy control sites at baseline (T0) and one-week post-treatment (T1). Microbial and fungal communities were characterized using Next-Generation Sequencing (NGS) of the 16S rRNA and ITS2 regions. Linear Mixed Models (LMM) and Spearman correlation were used to assess taxonomic shifts and cross-kingdom relationships. RESULTS: Sequencing revealed a promising ecological shift: the bacteriome shifted from anaerobic dominance (Olsenella, Peptostreptococcus) toward a health-associated aerobic profile, with Rothia near-doubling (11.91% to 22.68%). The mycobiome underwent a "normalization" effect: Candida abundance decreased significantly (22.8% to 9.1%), while fungal Shannon diversity in pockets returned to healthy-site levels. Inter-kingdom analysis identified antagonistic relationships between expanding commensal bacteria and opportunistic fungi, suggesting that the intervention may help re-establish a protective bacterial niche. CONCLUSIONS: The HA-H2O2-glycine formulation seems to facilitate a rapid, cross-kingdom modulation of the subgingival niche. By reducing anaerobic pathogens and normalizing the mycobiome it appear to induce short-term changes, suggesting potential as adjunctive strategy in periodontal management. CLINICAL SIGNIFICANCE: The present work underlines the possible cross-Kingdom effects of a novel compound.

Humans↗
PubMed2026

Clinical performance evaluation of single-shade versus multi-shade composite resins in non-carious cervical lesions: a 36-month randomized clinical trial.

BACKGROUND: Composite resins are widely used as the material of choice for definitive restorations due to their ability to integrate functional and aesthetic aspects in dental rehabilitation. Recently, one-shade composite resins have been introduced to simplify the clinical workflow. OBJECTIVES: This study aimed to compare the clinical performance of a "chameleon effect" composite resin with that of a multi-shade composite resin in non-carious cervical lesions after 36 months of follow-up. METHODS: This study was a randomized, controlled, double-blind clinical trial with an equivalence design using a split-mouth approach. The sample consisted of 60 patients presenting at least two non-carious cervical lesions, totaling 120 restorations. Restorations were performed using two materials from the same commercial brand: Vittra Unique (one-shade group) and Vittra APS (multi-shade group). The clinical performance of the restorations was longitudinally evaluated according to the FDI criteria. Survival analysis was performed using Kaplan-Meier curves and the log-rank test, while other clinical parameters were compared using the chi-square test (&#x3b1; = 0.05). RESULTS: At baseline, no statistically significant differences were observed between the groups regarding the evaluated biological, functional, and aesthetic parameters (p > 0.05). Both materials demonstrated clinically acceptable performance according to the FDI criteria, with no significant differences between them. CONCLUSIONS: After 36 months, no significant differences were observed between the one-shade and the multi-shade composite resins in the restoration of non-carious cervical lesions. CLINICAL SIGNIFICANCE: This 36-month randomized clinical trial demonstrates that single-shade composite resins achieve structural durability and aesthetic integration equivalent to traditional multi-shade layering when restoring non-carious cervical lesions. This evidence validates a simplified, single-shade restorative workflow, significantly reducing chairside time and operator-dependent variables without compromising the clinical longevity.

Humans↗
PubMed1975

A comparative clinical study of three periodontal surgical techniques.

A comparative 4-month trial was performed after initial preparation. The procedures used were curettage, replaced flap and apically repositioned flap procedures with osseous recontouring respectively in a split-mouth technique in 17 male and 23 female patients, 22 to 65 years old. Changes were assessed with plaque and gingival indices, and measurements of pocket depths, attachment levels and tissue contours. All procedures reduced pocket depths. Apically repositioned flaps were the most successful, reducing overall mean pockets from 3.5 to 1.9 mm. Changes in attachment levels post-operatively showed only a small degree of variation among the three surgical procedures, and would not affect the choice of the apically repositioned flap as the most effective method for pocket reduction. A marked improvement in tissue contour was obtained in those areas treated by apically repositioned flap procedures and osseous recontouring. Despite failure to improve tissue contour, replaced flap procedures showed an equal degree of success in maintaining plaque control when compared to apically repositioned flaps, as evidenced by static plaque indices. Replaced flap procedures were also the only group to show improved gingival health over the 4-month post-operative period with lower gingival indexes. It would seem that good healing, followed by a high standard of oral hygiene, may overcome the presence of gingival and marginal osseous deformities.

Adult↗
PubMed1978

A comparison of the scalloped and linear incisions as used in the reverse bevel technique.

Using a split-mouth technique in 20 patients, a comparison was made of the linear and scalloped incisions as used in the reverse bevel technique. Forty full thickness periodontal flap procedures were evaluated. The PlI and GI were recorded and gingival fluid collected at operation and at weeks 1, 2, 3, 4 and 12 after operation. Pocket depths and attachment levels were noted and gingival contour assessed, using the Contour Index, pre-operatively and 12 weeks after operation. Pain experience during the first week after operation was evaluated. No significant changes in PlI occurred throughout the study. The GI and gingival fluid flow showed comparable trends. More inflammation was present after the linear incision during the first 2 weeks after operation. Clinically, satisfactory results were achieved for both scalloped and linear incision procedures as shown by the improvement in gingival contour, reduction in pocket depth, slight gain in attachment, lack of gingivitis and low plaque scores.

Epithelial Attachment↗
PubMed1979

Clinical improvement of gingival conditions following ultrasonic versus hand instrumentation of periodontal pockets.

A study utilizing a split-mouth design in 18 subjects and with four operators was performed in order to compare the effect of hand and ultrasonic instrumentation of periodontal pockets. Contralateral pairs of teeth with pockets of comparable depth were treated by either hand or ultrasonic instruments. Instrumentation was repeated after 4 weeks. Pocket depth, bleeding on probing and gingival fluid measurements were used for evaluation. A gradual reduction of pocket depth and number of bleeding points took place throughout the 8-week experimental period. Clinically significant differences were not observed comparing the effect of hand instruments to ultrasonics for any of the operators. The amounts of gingival fluid were similar for both methods of instrumentation at the final examination. Thus, the present study failed to demonstrate any significant differences between the effect of ultrasonic root debridement and hand instrumentation in the treatment of 4-6 mm deep periodontal pockets.

Adult↗
PubMed1979

The effect of splinting on tooth mobility. I. During initial therapy.

The purpose of this study was to assess whether fixed splinting aided in the reduction of posterior tooth mobility during initial therapy. A "split-mouth" approach was used in order to compare splinted segments with similar unsplinted segments. Seven patients were selected, all of whom demonstrated chronic destructive periodontitis and mobile teeth. Initial therapy, consisting of oral hygiene instruction, root curettage and occlusal adjustment, was performed over a 2-week period. At the time of initial therapy, teeth in contralateral segments were splinted with an intracoronal wire-and-acrylic splint. Tooth mobility and gingival inflammation were recorded in all four segments every 3 weeks for a 15-week monitoring period following initial therapy. The splints were removed before each data recording session and then replaced and the occlusion refined. Prophylaxis and oral hygiene instruction were repeated every second week throughout the monitoring period. The reduction in the mobility of teeth splinted during the entire therapy period did not differ from the reduction observed in the unsplinted segments. The reduction in tooth mobility observed in both the splinted and unsplinted segments over the 17-week period can be attributed to the improved occlusal relationships and reduction in inflammation.

Adult↗
PubMed1992

A randomized trial of occlusal adjustment in the treatment of periodontitis patients.

The purpose of the randomized clinical trial was to test; (1) the influence of occlusal adjustment (OA) in association with periodontal therapy on attachment levels, pocket depth, and tooth mobility, (2) whether OA was of greater significance in non-surgically treated periodontal defects, and (3) whether initial tooth mobility or disease severity had an affect on post-treatment attachment levels following OA. After hygienic-phase therapy, 50 patients received OA/No OA according to random assignment; 22 patients received an OA and 28 were not adjusted. 2 months after OA, either modified Widman flap surgery or scaling and root planing by a periodontist were done according to random assignment within each patient in a split-mouth design. Following active treatment patients were maintained with prophylaxis done every 3 months and scored annually. For the analysis of this two-year data, a repeated measures analysis of variance was performed using attachment level change and pocket depths as outcome indicators. There was significantly greater gain of clinical periodontal attachment in patients who received an OA compared to those who did not. Both the surgically and non-surgically treated sides of the mouth responded similarly to OA. There was no affect of OA on the response in pocket depth, nor did initial tooth mobility or initial periodontal disease severity influence the response to OA.

Adult↗
PubMed1992

Gingivectomy versus flap surgery: the effect of the treatment of infrabony defects. A clinical and radiographic study.

The aim of this paper was to compare the short-term results of gingivectomy (GV) and modified Widman flap (MWF) surgery in the treatment of infrabony defects. 14 patients with 68 bilateral infrabony defects were selected. At baseline, and 3 and 6 months postoperatively, assessments of oral hygiene, gingival conditions, bleeding on probing, probing pocket depth and attachment level, were recorded. Conventional radiograps were obtained in a way that assured a reproducible projection geometry. In a split-mouth design, one jaw quadrant was randomly treated with GV, while the contralateral with a MWF. The changes of the bone tissue were assessed by means of conventional and subtraction images by 2 observers. The interobserver agreement of the conventional and subtraction technique was studied. The majority of the sites demonstrated a significant improvement in gingival conditions and a reduction in bleeding. For both treatments, probing depths were reduced by an average of 3 mm, while a mean of 1.22-1.35 mm of probing attachment gain was obtained. The GV resulted in slightly more gingival recession (1.90 mm) than the MWF (1.60 mm). The radiographic examination demonstrated gain of bone in 7 defects treated with GV and in 9 defects treated with MWF. This study demonstrated that pockets associated with infrabony defects can be successfully treated by both treatment modalities. Furthermore, bone gain can occur after treatment but not in a predictable manner.

Adolescent↗
PubMed1992

Patient preference regarding 4 types of periodontal therapy following 3 years of maintenance follow-up.

It has been shown that certain types of periodontal therapy result in greater post-therapy gingival recession. It has been suggested that this recession may lead to maintenance complications for patients. This study evaluated patient perceptions 3 years following the completion of 4 types of periodontal therapy (coronal scaling (CS), root planing (RP), modified Widman surgery (MW), and flap with osseous resectional surgery (FO)). 75 individuals completed split-mouth therapy and 3 years of maintenance follow-up. An interview survey of all patients categorized their perception for each treatment of their mouth concerning difficulty in cleaning, sensitivity to temperature, general "feeling" of the region, prevalence of localized symptoms, food retention, comfort of oral examination, and attitude toward repeating therapy. Responses to questions showed no statistically significant differences between treatment regions. Patterns demonstrated that FO-treated regions were perceived to have less food retention, but were more difficult to clean. It was generally found that at the end of 3 years of maintenance, patients felt their mouths were "normal", they experienced few localized symptoms, and were very willing to repeat any of the treatment regimens if necessary.

Chi-Square Distribution↗
PubMed1992

The effect of topical metronidazole therapy on experimentally-induced periodontitis in the beagle dog.

The present study was performed to assess the effect of topical metronidazole therapy on ligature-induced periodontitis in beagle dogs. 6 beagle dogs with experimentally-induced periodontitis on the mandibular 2nd, 3rd and 4th premolars were treated with metronidazole 10% dental paste 2 x daily for 4 weeks in an open placebo-controlled study using a split-mouth design. Recordings of probing pocket depth, bleeding on probing and gingival index were performed before commencement of treatment and repeated weekly during the 4-weeks treatment period. Concurrently, samples for microbiological analysis were collected from 2 of the dogs. The results demonstrated that probing pocket depth, bleeding on probing and gingival index had improved significantly in the metronidazole-treated side compared with the placebo-treated side. Black pigmented Bacteroides spp. and Spirochetes, present in all samples before treatment, were eliminated from the metronidazole-treated side after the 1st week of treatment and throughout the treatment period, whereas they were present in all samples from the placebo-treated side. The result of the present study demonstrates that topical application of metronidazole in a dental paste, improves the clinical features of the experimentally-induced periodontitis and eliminates some of the micro-organisms associated with the disease.

Animals↗
PubMed1992

Caries associated microflora in plaque from orthodontic appliances retained with glass ionomer cement.

The caries associated microflora in dental plaque adjacent to orthodontic brackets retained with a glass ionomer cement (GIC) and a resin based composite was investigated using the split-mouth technique. 3, 8, and 28 days after the onset of the appliances, 48-h-old plaque was sampled. An increasing prevalence of mutans streptococci and lactobacilli in plaque from both retaining materials was found. A tendency to colonize more frequently around the composite retained brackets was noticed for both types of bacteria. The proportion of mutans streptococci in relation to the total viable count was significantly higher in plaque samples from composite retained brackets compared to GIC retained 1 month after onset of treatment. The results suggest that a less caries inducing microflora may develop when GIC is used as luting agent in orthodontic dentistry.

Adolescent↗
PubMed1977

A comparison of tooth accumulated materials from quadrants treated surgically or nonsurgically.

The objective of this study was to test the validity of the clinical concept that periodontal surgery is beneficial in aiding the patient to reduce the amount of tooth accumulated materials in moderate to advanced cases of periodontal disease. Twelve arches in eight patients with moderate to severe bone loss were selected for this investigation. Using a split-mouth technique, 12 quadrants were subjected to pocket elimination by the use of osseous and soft tissue recontouring, and 12 quadrants received thorough deep scaling, root planing, and polishing. These patients were seen at 1,2, and 4 weeks after surgery for root planing and more oral hygiene instructions. At 6 weeks they received a prophylaxis, including root planing if indicated, throughout the mouth. The patients returned in 2 weeks, at which time plaque accumulations were then removed and collected by quadrant to be subjected to analysis using wet weights, dry weights and ash weights. The quantity of tooth accumulated debris on the surgically-treated quadrants was significantly greater than on those treated nonsurgically, as determined by the wet weight (P less than 0.01) and dry weight (P less than 0.05). There was, however, no significant difference with ash weight comparisons. The dry weight was the more accurate indicator of tooth accumulated materials. The mean ash weight on the surgically-treated mandibular quadrants (2.21 mg) was significantly greater (P less than 0.05) than from those treated nonsurgically (1.35 mg). The investigators' hypothesis that there would be more accretions on the side not involved in osseous surgery and pocket eradication was not supported in this study. Several possible reasons for this were elucidated and discussed.

Dental Deposits↗
PubMed1992

Intrapocket chemotherapy in adult periodontitis using a new controlled-release insert containing ofloxacin (PT-01).

PT-01 is a newly developed water-soluble controlled-release insert containing ofloxacin (OFLX) as an antibacterial agent. The effect of PT-01 was evaluated by split-mouth application after oral hygiene instruction. No mechanical debridement was carried out during the experiment. PT-01 was applied once a week for 4 weeks in the periodontal pockets of 46 patients with adult periodontitis. The control insert without any antibacterial agent was applied in a selected pocket in a different quadrant for each patient. Clinical findings plaque index, PI; gingival index, GI; bleeding on probing, BOP; pus discharge, pus; and probing depth, PD at both PT-01 and control sites were measured at every visit for 4 weeks. Clinical findings were improved at both PT-01 and control sites, but the improvements were much more significant at PT-01 sites, in particular BOP and PD, than at control sites. PI was also significantly reduced at PT-01 sites. These results suggest that weekly application of PT-01 in the periodontal pocket has a significant effect on the resolution of periodontal inflammation and has an inhibitory effect on supragingival plaque deposition.

Adult↗