NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration

Study Overview
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Brief Summary
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Three techniques for periodontal reconstruction will be compared, in which marginal access versus apical access will be carried out.

Official Title
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Non-Incised Papillae Surgical Approach (NIPSA) Versus Marginal Approach by Palatal Incision and Minimally Invasive Surgical Technique (MIST) in Periodontal Regeneration: a Ramdomized Clinical Trial

Conditions
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Periodontitis, Periodontal Diseases, Periodontal Pocket

Intervention / Treatment
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* Procedure: Non-incised papillae surgical approach (NIPSA)
* Procedure: marginal approach by palatal incision
* Procedure: Minimally invasive surgical technique (MIST)


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 |
| --- | --- |
| Experimental: Non-incised papillae surgical approach (NIPSA)<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 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 papillae surgical approach (NIPSA)<br>* Periodontal reconstructive surgery<br>|
| Active Comparator: marginal approach by palatal incision<br>A small incision in the palatal aspect and a limited papila elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces. | Procedure: marginal approach by palatal incision<br>* Periodontal reconstructive surgery<br>|
| Active Comparator: Minimally invasive surgical technique (MIST)<br>The incision of the defect-associated papilla will be performed according to the principles of the papilla preservation techniques. Enamel matrix derivates will be applied on the debrided root surfaces. Stable primary closure of the flaps will be obtained with internal modified mattress sutures. | Procedure: Minimally invasive surgical technique (MIST)<br>* Periodontal reconstructive surgery<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 |