Three Types of Papilla Incision in Periodontal Surgery

Not Applicable

Recruiting

• Conditions: Periodontitis; Periodontal Pocket; Periodontal Diseases
• Interventions: Procedure: Midline interproximal soft-tissue incision; Procedure: Minimally invasive surgical technique; Procedure: Marginal approach by palatal incision

• Registration Number: NCT06428149
• Lead Sponsor: Universidad de Murcia

Brief Summary

Three types of papilla incision in periodontal reconstruction techniques will be compared.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-05-20
• Study First Posted: 2024-05-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients diagnosed with periodontal disease.
• Active residual pockets associated with intraosseous defects that did not resolve with non-surgical treatment after 1 year of maintenance.
• Intraosseous lesions with probing depth greater than 5 mm or extension of the radiographic defect greater than 4 mm.
• Plaque index and bleeding index less than 30%.

Exclusion Criteria

• Systemic disease that contraindicates periodontal surgery.
• Pregnant women.
• Third molars or teeth with incorrect endodontic or restorative treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midline interproximal soft-tissue incision	Midline interproximal soft-tissue incision	Marginal approach by midline interproximal soft tissue incision and a limited papilla elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces.
Minimally invasive surgical technique	Minimally invasive surgical technique	The incision of the defect-associated papilla will be performed according to the principles of the papilla preservation techniques. Enamel matrix derivates will be applied on the debrided root surfaces. Stable primary closure of the flaps will be obtained with internal modified mattress sutures.
Marginal approach by palatal incision	Marginal approach by palatal incision	A small incision in the palatal aspect and a limited papilla elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces.

Primary Outcome Measures

Name	Time	Method
Bleeding on probing	12 months	Bleeding on probing could be positive or negative
Clinical attachment level (CAL)	12 months	Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket
Recession (REC)	12 months	Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.
Probing pocket depth (PD)	12 months	Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket
Location of the tip of the papillae (TP)	12 months	Location of the tip of the papillae. Taking as reference the level of the mid-axis of the tooth, will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise. This outcome will be assessed with a periodontal probe and measured in mm.
Keratinized tissue width (KT)	12 months	Keratinized tissue width will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.

Secondary Outcome Measures

Name	Time	Method
Supra-alveolar attachment gain (SUPRA-AG)	12 months	Subtracting the 12 month CAL from the intrasurgically Bone Component-CEJ will provide the SUPRA-AG result.

Trial Locations

Locations (1)

Centro Odontologico Del Sureste Slp; 🇪🇸 Murcia, Spain