RecruitingNot ApplicableNCT03997578

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

Sponsor

Universidad de Murcia

Enrollment

40 participants

Start Date

Sep 3, 2019

Study Type

INTERVENTIONAL

Conditions

Periodontitis Periodontal; Lesion Periodontal Bone Loss

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the NIPSA surgical technique combined with a connective tissue graft and Emdogain (a protein-based regenerative material) for treating deep periodontal bone defects. Periodontitis destroys the bone and gum tissue that hold teeth in place. The NIPSA approach avoids cutting the delicate interdental papillae (the small triangles of gum between teeth), potentially allowing better healing with less recession. Emdogain mimics the proteins that originally formed the tooth's attachment, stimulating regeneration. Participants will have surgery using this combined technique and be followed over time to measure bone regrowth, pocket depth reduction, and gum tissue health. This study builds on prior research testing NIPSA in different configurations. You may be eligible if: - You have been diagnosed with periodontitis - Your plaque and bleeding scores are below 30% - You have a gum pocket depth greater than 5 mm - You have an intrabony defect greater than 3 mm involving the buccal (cheek-side) wall You may NOT be eligible if: - You have a systemic disease that contraindicates surgery - The tooth requiring treatment is a wisdom tooth - The tooth has inadequate root canal treatment or restorations Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENIPSA (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.

PROCEDURENIPSA 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.