NCT03997578

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

Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Enamel Matrix Derivated and Xenograft for the Treatment of Periodontal Defects: A Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Universidad de Murcia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Periodontitis
• Periodontal Bone Loss
• Periodontal; Lesion

Interventions

Type	Name	Description
PROCEDURE	NIPSA (Non-incised papilla surgical approach)	To access the defect, 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 incision will be extended mesiodistally as necessary to allow access to the defect and correct debridement of the granulation tissue. 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 regenerative biomaterials 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.
PROCEDURE	NIPSA plus connective tissue graft	In these patients, the following methodology will be added to the technique described for the NIPSA group: once the biomaterials are applied, a connective tissue graft, taken at the level of the first upper molar, will be sutured to the base of the soft supra-alveolar tissue and to the palatal tissue, which has not been disinserted, using simple sutures.

Timeline

• Start date: 2019-09-03
• Primary completion: 2026-12-01
• Completion: 2027-02-02
• First posted: 2019-06-25
• Last updated: 2026-02-19

Locations

1 site across 1 country: Spain