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

Universidad de Murcia

Status: Completed

Conditions: Periodontitis; Periodontal Attachment Loss; Periodontal Pocket; Periodontal Diseases

Treatments: Procedure: Non-incised papila surgical approach with grafting biomaterial; Procedure: Non-incised papila surgical approach without grafting biomaterial

Study type: Interventional

Funder types: Other

Identifiers

NCT04712630

2441/2019

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups

NIPSA without grafting biomaterial

Experimental group

Description:

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.

Treatment:

Procedure: Non-incised papila surgical approach without grafting biomaterial

NIPSA with grafting biomaterial

Active Comparator group

Description:

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.

Treatment:

Procedure: Non-incised papila surgical approach with grafting biomaterial