Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment

Not Applicable

Recruiting

• Conditions: Periodontal Bone Loss; Periodontal Diseases; Periodontal Pocket
• Interventions: Procedure: periodontal surgery

• Registration Number: NCT05533528
• Lead Sponsor: Universidad de Murcia

Brief Summary

The objective of this study will be to evaluate a new protocol for the surgical treatment of periodontal disease with two novelties: to make a single incision in the midline of the interproximal area to respect the vascular supply and preserve the granulation tissue with regenerative potential.

The investigators will carry out a controlled and randomized clinical trial with a control group (n=25; modified Kirkland flap) and a test group (n=25; experimental surgical protocol: incision in the mid-interproximal area of the papilla and preservation of the granulation tissue).

Clinical parameters will be taken at the time of surgery and 12 months follow-up: bleeding on probing (BoP), clinical attachment level (CAL), residual probing depth (rPD),Probing pocket depth reduction (PPDr), recession (REC), interproximal gingival recession (iGR), width of keratinized gingiva (KT), gain of supra-alveolar clinical attachment (SUPRA-AG), early wound healing index (EHI).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-03
• Study First Submitted: 2022-09-05
• Study First Submitted QC: 2022-09-05
• Study First Posted: 2022-09-09
• Status Verified: 2024-12
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-12-22
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Stage III or IV periodontitis, including all grades.
• Unresolved deep pockets (probing pocket depth [PPD] >5 mm + BoP) 4 to 6 weeks after non-surgical treatment.
• Interproximal plaque index <35% maintained during periodontal treatment and maintenance.
• Adherence to periodontal maintenance appointments.

Exclusion Criteria

• Systemic disease contraindicating periodontal surgery.
• Teeth with incorrect endodontic treatment or restoration.
• Stage I or II periodontitis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	periodontal surgery	Access flap periodontal surgery
Test	periodontal surgery	Access flap periodontal surgery and periodontal granulation tissue debridement.

Primary Outcome Measures

Name	Time	Method
Clinical attachment gain (CAG)	12 months	Clinical attachment gain

Secondary Outcome Measures

Name	Time	Method
PPDr	12 months	Probing pocket depth reduction
rPD	12 months	residual probing depth
iGR	12 months	interproximal gingival recession
Early Healing Index (EHI)	1 week	Five types of early healing will be recorded: EHI 1, complete closure of the incision line, with no fibrin; EHI 2-3, formation of a thin line or a fibrin clot in the incision area, respectively; EHI 4-5, incomplete closure with partial necrosis or necrosis of the incision area, respectively.
SUPRA-AG	12 months	Supra-alveolar attachment gain

Trial Locations

Locations (1)

Centro Odontologico Del Sureste Slp; 🇪🇸 Murcia, Spain