Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft

Not Applicable

Completed

• Conditions: Periodontal Pocket; Periodontal Diseases; Periodontal Attachment Loss; Periodontitis
• Interventions: Procedure: Non-incised papila surgical approach with grafting biomaterial; Procedure: Non-incised papila surgical approach without grafting biomaterial

• Registration Number: NCT04712630
• Lead Sponsor: Universidad de Murcia

Brief Summary

This study compared the clinical outcomes of the non-incised papila surgical approach (NIPSA) alone and with grafting biomaterial.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-09
• Primary Completion: 2020-09-09
• Study Completion: 2020-12-30
• Status Verified: 2021-01
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-14
• Last Update Submitted: 2021-01-14
• Study First Posted: 2021-01-15
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• patients diagnosed with periodontitis.
• plaque index and bleeding index of < 30%.
• periodontal lesions with pocket probing depth > 5 mm.
• intrabony defect > 3 mm.
• intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.

Exclusion Criteria

• patients with systemic diseases that contraindicated treatment.
• third molars.
• teeth with incorrect endodontic or restorative treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIPSA with grafting biomaterial	Non-incised papila surgical approach with grafting biomaterial	A single horizontal or oblique apical incision will be made in the mucosa located on the bony cortex, far from the marginal tissues and apically to the edge of the bony crest delimiting the defect. The tissue coronal to the incision will be raised full thickness, trying to maintain the preoperative papillae architecture intact. The granulation tissue and epithelium of the pocket will be eliminated. The affected root will be scaled and planed, and calculus eliminated. Once the defect will be debrided, the enamel matrix derivates will be applied and the bone defect will be filled with a composite of xenograft and enamel matrix derivates. Then the incision line will be sutured by a double suture line to facilitate closing without tension: The first with internal horizontal mattress sutures to approximate the connective tissue of both edges of the mucosal incision, and the second with single interrupted sutures.
NIPSA without grafting biomaterial	Non-incised papila surgical approach without grafting biomaterial	A single horizontal or oblique apical incision will be made in the mucosa located on the bony cortex, far from the marginal tissues and apically to the edge of the bony crest delimiting the defect. The tissue coronal to the incision will be raised full thickness, trying to maintain the preoperative papillae architecture intact. The granulation tissue and epithelium of the pocket will be eliminated. The affected root will be scaled and planed, and calculus eliminated. Once the defect will be debrided, the enamel matrix derivates will be applied. Then the incision line will be sutured by a double suture line to facilitate closing without tension: The first with internal horizontal mattress sutures to approximate the connective tissue of both edges of the mucosal incision, and the second with single interrupted sutures.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
Bleeding on probing	12 months	Bleeding on probing could be positive or negative.

Secondary Outcome Measures

Name	Time	Method
Wound closure (WC)	1 week	Complete wound closure (CWC = 2) Incomplete wound closure (IWC = 1) necrosis (NT = 0).
Supra-alveolar attachment gain (SUPRA-AG)	12 months	Subtracting the 12-month CAL from the intra-surgically BC-CEJ will provide the SUPRA-AG result.

Trial Locations

Locations (1)

Centro Odontologico Del Sureste Slp; 🇪🇸 Murcia, Spain