Efficacy of Access Flap Surgery on Subgingival Periodontopathogen Levels in Periodontitis Patients: A Split-Mouth Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Trakya University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The mean fold change in the quantities of P. gingivalis
Study Overview
Brief 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.
Detailed Description
The participants in the present study were individuals diagnosed with stage III grade B periodontitis, as determined by the criteria established in the 2017 World Workshop for the Classification of Periodontal Diseases and Conditions.
Non-surgical periodontal treatment was administered to all quadrants in patients scheduled to participate in the study, using periodontal hand instruments (Gracey curettes, Hu-Friedy®; Chicago, IL) in conjunction with an ultrasonic device (Cavitron Plus, Dentsply®, Duisburg, Germany). Each patient underwent the first step of non-surgical periodontal treatment, which involved the mechanical removal of supragingival deposits, motivation, and personalized oral hygiene instructions, including interdental plaque control and toothbrushing using the modified Bass technique. In the first week following the initial session, the second step of the non-surgical periodontal treatment, which encompassed subgingival instrumentation (SI), was performed on all four quadrants in a single appointment administered by the same blinded operator. Patients did not receive any prescribed medication or mouthwash. At the one-month follow-up visit after SI (14 days pre-surgery), patients were clinically re-examined, and their compliance with the inclusion/exclusion criteria was reassessed. Patients requiring access flap surgery, indicated by the presence of deep residual pockets (PD ≥ 6 mm), were identified and underwent the randomization procedure. 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. Other patients determined not to need access flap surgery were not included in the study and were instead enrolled in repeat subgingival instrumentation or a supportive periodontal care program.
Patients were assigned consecutive ascending numbers during the enrollment visit. Prior to the commencement of the study, the order of treatment quadrants was randomized by an investigator not directly involved in the examination or treatment process, using random sequences generated by a computer random-number generator. Allocation concealment was achieved using opaque sealed envelopes, sequentially numbered. Based on this process, the teeth on the right or left site were designated as the test group while those on the opposite site were assigned to the control group. The allocation remained concealed from the examiner throughout the periodontal examination and recordings, and the envelope was not opened by the operator until the first treatment visit.
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 Following local anesthesia, mucoperiosteal flap was elevated and handled with microsurgical instruments (Blades, scalpel, needle holder, scissor, and tweezer, Carl Martin GmbH, Solingen, Germany) in accordance with the simplified papilla preservation flap (SPFF) technique. 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.
Periodontal measurements including probing depth (PD) (mm), clinical attachment level (CAL) (mm), bleeding on probing (BOP) (±), gingival index (GI), and plaque index (PI)were assessed at two distinct time intervals by a calibrated periodontist who was blinded to the experimental sites.20 These measurements were conducted on six different aspects of each tooth (disto-buccal/labial, mid-buccal/labial, mesio-buccal/labial, disto-lingual/palatinal, mid-lingual/palatinal, and mesio-lingual/palatinal) using a manual periodontal probe (Williams probe, Hu-Friedy®; Chicago, IL), and the average value was computed. To evaluate the healing of periodontal tissues, detailed periodontal scores were recorded prior to and four weeks after access flap surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 36 Years to 58 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Having 20 or more permanent teeth, excluding third molars and teeth with endodontic lesions;
- •Exhibiting periodontitis with more than 30% loss of periodontal support tissue; - Having at least two non-adjacent teeth with a probing depth (PD) ≥6 mm, clinical attachment level (CAL) ≥5 mm, and radiographic bone loss extending to at least the middle of the root16;
- •Presenting with bleeding on probing (BOP) in at least 40% of all periodontal sites17;
- •Having at least one tooth per quadrant meeting the aforementioned PD and CAL criteria.
Exclusion Criteria
- •Pregnancy or lactation;
- •Systemic diseases potentially affecting immune response (e.g., diabetes mellitus, bone metabolic diseases, HIV, immunosuppressive therapy, radiation);
- •Presence of caries, restoration, or prosthesis adjacent to the sampling site;
- •Use of anti-inflammatory drugs or antibiotics within the previous 3 months.
Arms & Interventions
Access flap surgery group
Quadrants in participants requiring periodontal surgery were randomly assigned to access flap surgery sites. Following local anesthesia, a mucoperiosteal flap was elevated and handled with microsurgical instruments (blades, scalpel, needle holder, scissors, and tweezers; Carl Martin GmbH, Solingen, Germany) in accordance with the simplified papilla preservation flap (SPPF) technique.
Intervention: Access flap surgery (Procedure)
Control group
untreated sites
Outcomes
Primary Outcomes
The mean fold change in the quantities of P. gingivalis
Time Frame: Before and four weeks after surgery
RT- qPCR was carried out to detect the 16S rRNA gene of subgingival red complex species. The mean fold change in P. gingivalis counts was analyzed.
The mean fold change in the quantities of T.denticola
Time Frame: Before and four weeks after surgery
RT- qPCR was carried out to detect the 16S rRNA gene of subgingival red complex species. The mean fold change in T.denticola counts was analyzed.
The mean fold change in the quantities of T.forsythia
Time Frame: Before and four weeks after surgery
RT- qPCR was carried out to detect the 16S rRNA gene of subgingival red complex species. The mean fold change in T.forsythia counts was analyzed.
Secondary Outcomes
- percentage of sites with BOP positive of each patient(Before and four weeks after surgery)
- changes in the sum of the PI values of each patient(Before and four weeks after surgery)
- changes in the sum of the GI values of each patient(Before and four weeks after surgery)
- changes in mean PD values(Before and four weeks after surgery)
- changes in mean CAL values(Before and four weeks after surgery)
Investigators
Ece AÇIKGÖZ ALPARSLAN
Assistant professor
Trakya University
