CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Access flap surgeryprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06684288
NCT06684288N/ACompleted

Efficacy of Access Flap Surgery on Subgingival Periodontopathogen Levels in Periodontitis Patients: A Split-Mouth Randomized Clinical Trial

Trakya University·interventional·Posted Nov 12, 2024·Updated Jan 8, 2025

In Brief

A clinical study evaluating Access flap surgery for Periodontitis. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The participants in the present study were individuals diagnosed with stage III grade B periodontitis. Each patient underwent the first step of non-surgical periodontal treatment. In the first week following the initial session, the second step of the non-surgical periodontal treatment was performed on all four quadrants in a single appointment administered by the same blinded operator. Different sites of participating patients scheduled for periodontal surgery were assigned as either access flap surgery sites (test group) or untreated sites (control group) through a randomization procedure. Each patient who met the study criteria underwent one of the following: one side of the mouth was treated with AFS, while the contralateral quadrants served as the control. All the access surgeries were conducted by the same blinded periodontist. To evaluate the healing of periodontal tissues, detailed periodontal scores were recorded prior to and four weeks after access flap surgery. The molecular genetic identification and quantification (qPCR) of subgingival periodontopathogens were performed by an operator who was blinded to group distribution. In the qPCR method, an increase in the number of cycles corresponds to a concomitant increase in the amount of DNA detected by the fluorescent dye. The Ct values obtained from the analysis results of subgingival plaque samples were integrated into the 2-ΔCt formula to calculate the difference in fold change occurring in the quantities of microorganisms. Continuous variables were assessed for normality using the Shapiro-Wilk test. Subsequently, based on the normal distribution assumption, comparisons between independent groups were conducted using either the Student's t-test or the Mann-Whitney U test. For comparisons between dependent groups, the analyses employed either the Paired t-test or the Wilcoxon test.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeriodontitis
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedNov 12, 2024
Enrollment StartMay 21, 2021
Primary CompletionJan 7, 2022
Study CompletionFeb 5, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 1.6 years ago

Interventions

Access flap surgeryprocedure

Granulation tissue attached to the alveolar bone was excised to ensure complete access and optimal visibility of the root surfaces. In addition, instrumentation was performed using a combination of ultrasonic and hand instruments, and no alveolar bone modification was undertaken during the flap procedure. Subsequently, the mucoperiosteal flap was repositioned and primarily closed with proximal simple sutures employing monofilament suture material (5/0 Propilen, Dogsan, Türkiye). Patients were given post-operative recommendations; however, no medication was prescribed.