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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Periodontitis, Periodontal Bone Loss, Periodontal; Lesion

Intervention / Treatment
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* Procedure: NIPSA (Non-incised papilla surgical approach)
* Procedure: NIPSA plus connective tissue graft


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NIPSA<br>Patients will be treated with only NIPSA technique. | Procedure: NIPSA (Non-incised papilla surgical approach)<br>* 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.<br>|
| Experimental: NIPSA plus Connective tissue graft<br>Patients will be treated with NIPSA technique associated to a connective tissue graft. | Procedure: NIPSA plus connective tissue graft<br>* 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.<br>|

What is the study measuring?
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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 mmm. | 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 |