Efficacy of Access Flap Surgery on Subgingival Peridontopatgogens in Individuals With Periodontitis

NCT06684288 | Completed

• 1 other identifier: 2021/80
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (3)

• The mean fold change in the quantities of P. gingivalis

  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.

  Before and four weeks after surgery

• The mean fold change in the quantities of T.denticola

  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.

  Before and four weeks after surgery

• The mean fold change in the quantities of T.forsythia

  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.

  Before and four weeks after surgery

Secondary Outcomes (5)

• 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

Study Arms (2)

Access flap surgery group

EXPERIMENTAL

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.

Procedure: Access flap surgery

Control group

NO INTERVENTION

untreated sites

Interventions

Access flap surgery PROCEDURE

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.

Access flap surgery group

Eligibility Criteria

• Age: 36 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, 22030, Turkey (Türkiye)

Location

Related Publications (5)

• Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.

  PMID: 32383274 BACKGROUND

• Coffey J, Choudhry M, Shlossman M, Makin IRS, Singh VK. Multiplex real-time PCR detection and relative quantification of periodontal pathogens. Clin Exp Dent Res. 2016 Aug 11;2(3):185-192. doi: 10.1002/cre2.37. eCollection 2016 Dec.

  PMID: 29744166 BACKGROUND

• Kyriazis T, Gkrizioti S, Tsalikis L, Sakellari D, Deligianidis A, Konstantinidis A. Immunological and microbiological findings after the application of two periodontal surgical techniques: a randomized, controlled clinical trial. J Clin Periodontol. 2013 Nov;40(11):1036-42. doi: 10.1111/jcpe.12149. Epub 2013 Aug 22.

  PMID: 24033812 BACKGROUND

• Levy RM, Giannobile WV, Feres M, Haffajee AD, Smith C, Socransky SS. The effect of apically repositioned flap surgery on clinical parameters and the composition of the subgingival microbiota: 12-month data. Int J Periodontics Restorative Dent. 2002 Jun;22(3):209-19.

  PMID: 12186343 BACKGROUND

• Bayram C, Acikgoz-Alparslan E. Efficacy of Periodontal Surgery on Subgingival Periodontopathogen Levels in Periodontitis Patients: A Randomized Clinical Trial. Int J Dent. 2025 Dec 26;2025:4419048. doi: 10.1155/ijod/4419048. eCollection 2025.

  PMID: 41476849 DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ece Açıkgöz Alparslan

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 12, 2024
• Study Start: May 21, 2021
• Primary Completion: January 7, 2022
• Study Completion: February 5, 2022
• Last Updated: January 8, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)