Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects

Not Applicable

Recruiting

• Conditions: Periodontal; Lesion; Periodontitis; Periodontal Bone Loss
• Interventions: Procedure: NIPSA (Non-incised papilla surgical approach); Procedure: NIPSA plus connective tissue graft

• Registration Number: NCT03997578
• Lead Sponsor: Universidad de Murcia

Brief Summary

The present study pretends to show the results of combining a modification of the Non-incised papillae surgical approach (NIPSA) attempting to improve the outcome in the treatment of teeth with advanced periodontal support loss.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-22
• Study First Posted: 2019-06-25
• Study Start: 2019-09-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-12-01
• Study Completion: 2026-05-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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	NIPSA (Non-incised papilla surgical approach)	Patients will be treated with only NIPSA technique.
NIPSA plus Connective tissue graft	NIPSA plus connective tissue graft	Patients will be treated with NIPSA technique associated to a connective tissue graft.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Centro Odontologico Del Sureste Slp; 🇪🇸 Murcia, Spain