Nonincised Papillae in the Treatment of Intrabony Defects.

Study Overview
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Brief Summary
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The primary objective of the present study is to clinically and radiographically evaluate nonincised papillae surgical approach and entire papilla preservation approach for the treatment of intrabony defects with GTR membrane and hydroxyapatite graft.

Detailed Description
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Various procedures to treat intrabony defects by preserving the interdental papilla include conventional, simplified, and modified papilla preservation techniques. The drawback of these techniques is the post-surgical gingival recession. In order to overcome this drawback, the entire papilla preservation technique has been proposed, by preserving the whole integrity of the defect associated papilla providing a tunnel-like undermining incision. Recently a novel surgical procedure, termed nonincised papillae surgical approach (NIPSA), was designed to maintain the integrity of the interdental soft tissues covering intrabony defects. This would prevent biomaterial exposure associated with loss of papillary height, increase the amount of space for hard and soft tissue regeneration, and minimize gingival recession.

Official Title
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A Comparative Evaluation of Nonincised Papillae and Entire Papilla Preservation Surgical Approach in the Treatment of Intrabony Defects - a Clinical and Radiographic Study

Conditions
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Reconstructive Surgical Procedure

Intervention / Treatment
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* Procedure: Experimental- Nonincised papillae surgical approach
* Procedure: Active comparator- Entire papilla preservation technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy individuals within an age group 30-60yrs with chronic periodontal disease. Presence of two or more intrabony defects with probing pocket depth ≥5mm, CAL≥5mm, and radiographic depth ≥4mm. Adequate attached gingiva of 3mm and vestibular depth of 8mm. - Exclusion Criteria: Uncontrolled systemic disease. Pregnancy and lactation. Defects involving lingual sites. Presence of restoration in the experimental teeth. Smokers -

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 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
Interventional Model Description: GROUP A: NONINCISED PAPILLAE SURGICAL APPROACH (NIPSA) GROUP B: ENTIRE PAPILLA PRESERVATION TECHNIQUE (EPP)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nonincised Papillae Surgical Approach<br>Nonincised papillae surgical approach is a papillae preservation technique, where an apical approach is carried out, without incisions or disinsertion of tissues at the level of the papillae or marginal tissues. | Procedure: Experimental- Nonincised papillae surgical approach<br>* The basic principle of the technique is the placement of only one buccal horizontal or oblique incision in the mucosa, as apically as possible from the periodontal defect and the marginal tissues, and the raising of a mucoperiosteal flap coronally, which permits apical access to the defect but leaving the marginal tissues intact, acting as a dome for the protection of the clot.<br>* Other names: NIPSA;|
| Active Comparator: Entire Papilla Preservation Technique<br>Entire Papilla preservation technique is a tunnel-like procedure to preserve the defect associated papilla | Procedure: Active comparator- Entire papilla preservation technique<br>* The entire Papilla Preservation Technique is to preserve the whole integrity of the defect- associated papilla providing a tunnel-like undermining incision. The completely preserved interdental papilla provides an intact gingival chamber to stabilize the blood clot and improve the wound healing process. To provide adequate access for debridement, EPP requires a short buccal vertical releasing incision on the buccal side of the neighboring tooth extending just beyond the mucogingival line.<br>* Other names: EPP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CLINICAL ATTACHMENT LEVEL (CAL) | measured from the cemento-enamel junction (CEJ) to the bottom of the pocket | Baseline to 6 months | 
| POCKET PROBING DEPTH (PPD) | from the gingival margin to the bottom of the pocket; | Baseline to 6 months | 
| Intrabony component (INTRA) of the defect | the distance from the most coronal extension of the interdental bone crest (BC) to the bottom of the defect (BD) (BC-BD). | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Papilla loss (PL) | measured from contact point to tip of the papilla. | Baseline to 6 months | 
| Local bleeding score | recorded as positive when bleeding on probing was present at the surgical site. | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis; reconstructive surgical procedure;, guided tissue regeneration;, surgical flaps;treatment outcome