Non-Incised Papilla Flap in Deep Supraossous Defects

Study Overview
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Brief Summary
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The objective of this study was to assess the effectiveness of NIPSA in periodontal lesions with deep supra-alveolar defects, measuring the clinical efficacy of this flap. The non-incised papilla surgical approach (NIPSA) is a novel technique that accesses the periodontal defect from apical direction and was established with the aim of creating clinical advances compared with marginal access techniques. The defects with a supra-alveolar components are more frequent than intrabony defects, there is very little evidence about their treatment .

Official Title
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Non-Incised Papilla Flap With and Without Connective Tissue Graft for Management of Deep Supraossous Defects

Conditions
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Periodontitis

Intervention / Treatment
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* Procedure: Non-incised papila surgical approach only
* Procedure: Non-incised papila surgical approach with connective tissue grafting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of periodontal disease (periodontitis stage III and IV, grade A [12]; non-smokers and former smokers who quit smoking at least 1 year previously previous treatment for periodontal disease using non-surgical periodontal treatment completion of step I and II of periodontal therapy compliance with periodontal maintenance and oral hygiene (FMPS at baseline ≤ 30%) active residual pockets (positive bleeding on probing; BoP) associated with intrabony defects that were not resolved with non-surgical treatment after 4-6 months of maintenance. periodontal lesions with probing depth (PD) > 6 mm and supraalveolar defect (pre-diagnosis clinically (periodontal probe) Exclusion Criteria: systemic disease contraindicating periodontal surgery, smokers, and third molars or teeth with incorrect endodontic or restorative treatment.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIPSA in deep supra-alveolar defects without connective tissue graft<br> | Procedure: Non-incised papila surgical approach only<br>* Reconstructive periodontal surgery<br>|
| Active Comparator: NIPSA in deep supra-alveolar defects with connective tissue graft<br> | Procedure: Non-incised papila surgical approach with connective tissue grafting<br>* Reconstructive periodontal surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interproximal clinical attachment level gain | measured from CEJ to base of pocket depth by using periodontal prob | 6 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual pocket depth | distance from gingival margin to pocket depth by using periodontal prob | 6 MONTHS |