Non - Incised Papilla Versus Single Flap Technique In The Reconstruction Of Intrabony Defect

Study Overview
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Brief Summary
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The present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA. Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar attachment gain (SUPRA-AG)

Detailed Description
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The present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA. Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar attachment gain (SUPRA-AG)

Official Title
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Non - Incised Papilla Versus Single Flap Technique In The Reconstruction Of Intrabony Defect: a Randomized Controlled Trial

Conditions
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Periodontal Attachment Loss

Intervention / Treatment
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* Procedure: non - Incised Papilla surgical approach NIPSA for intrabony defect
* Procedure: single-flap approach SFA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Age > 18 years Diagnosis with stage III-IV periodontitis. Presence of one or more intrabony defects with probing pocket depth (PPD) > 5 mm and radiographic defect depth > 4 mm. Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 30% (measured at four sites per tooth). No relevant systemic condition or disease. Exclusion Criteria: Third molars and teeth with type III mobility or with an 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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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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non - Incised Papilla surgical approach NIPSA for intrabony defect<br>Group I will be allocated to non - Incised Papilla surgical approach NIPSA for intrabony defect with DBBM and PRF | Procedure: non - Incised Papilla surgical approach NIPSA for intrabony defect<br>* As described by Rodríguez and Caffesse in 2018, a single incision apical to the defect ,on the buccal aspect, only one apical horizontal or oblique incision will be made in the alveolar mucosa, as far removed as possible from the interdental papillae and marginal keratinized tis- sues. Following flap reflection, the bony defect will be examined carefully. Root planing is performed,. Flap closure will be performed by horizontal mattress sutures, placed 3 mm away from the borders, will be used as the first line of closure, promoting connective tissue contact between both edges of the incision, and single interrupted sutures will then be placed as a second line of closure. Using 5/0 polypropylene monofilament suture, Assut, Swiss<br>|
| Active Comparator: single-flap approach<br>group II will be allocated to single-flap approach SFA for intrabony defect with DBBM and PRF | Procedure: single-flap approach SFA<br>* As described by Trombelli et al 2010, A horizontal, butt-joint incision will be performed at the interdental papilla 1-2 mm coronal to the bone crest (as detected through pre-operative bone sounding). -A buccal mucoperiosteal envelope flap will be elevated by using a microsurgical periosteal elevator, leaving the residual portion of the interdental supracrestal soft tissues undetached.Flap closure will be performed by a horizontal internal mattress suture,will be performed at the base of the papilla, and a second internal mattress suture (vertical or horizontal) was performed between the most coronal portion of the flap and the most coronal portion of the palatal/lingual papilla. Using a resorbable suture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interproximal clinical attachment level change | CAL, measured in the interproximal space from the CEJ to the base of the pocket(BP)using a millimeter periodontal probe | at baseline ,6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual probing pocket depth (PPD), pocket depth (PD) change, | -Inter- proximal PD, measured in the interproximal space from the gingival margin to the BP measured by a millimeter periodontal probe | at at baseline ,6 and 12 months |