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

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

Official Title
-----------------
Clinical and Radiographic Outcomes of the Apical Approach in Periodontal Surgery Reconstruction With and Without Graft Materials: Non-Incised Papillae Surgical Approach (NIPSA). A Randomized Controlled Clinical Trial

Conditions
-----------------
Periodontitis, Periodontal Diseases, Periodontal Pocket, Periodontal Attachment Loss

Intervention / Treatment
-----------------
* Procedure: Non-incised papila surgical approach without grafting biomaterial
* Procedure: Non-incised papila surgical approach with grafting biomaterial


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIPSA without grafting biomaterial<br>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. | Procedure: Non-incised papila surgical approach without grafting biomaterial<br>* Periodontal reconstructive surgery<br>|
| Active Comparator: NIPSA with grafting biomaterial<br>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. | Procedure: Non-incised papila surgical approach with grafting biomaterial<br>* Periodontal reconstructive surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing pocket depth (PD) | Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket | 12 months | 
| Clinical attachment level (CAL) | Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket. | 12 months | 
| Recession (REC) | Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith. | 12 months | 
| Location of the tip of the papillae (TP) | 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. | 12 months | 
| Keratinized tissue width (KT) | 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. | 12 months | 
| Bleeding on probing | Bleeding on probing could be positive or negative. | 12 months | 

Secondary Outcome Measures

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