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

Primary Purpose

Periodontal Attachment Loss

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
non - Incised Papilla surgical approach NIPSA for intrabony defect
single-flap approach SFA
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Attachment Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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. -

Sites / Locations

  • faculty of dentistry ,Assiut universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

non - Incised Papilla surgical approach NIPSA for intrabony defect

single-flap approach

Arm Description

Group I will be allocated to non - Incised Papilla surgical approach NIPSA for intrabony defect with DBBM and PRF

group II will be allocated to single-flap approach SFA for intrabony defect with DBBM and PRF

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 24, 2023
Last Updated
August 19, 2023
Sponsor
Ain Shams University
Collaborators
Assiut University, Egyptian Russian University
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1. Study Identification

Unique Protocol Identification Number
NCT06003322
Brief Title
Non - Incised Papilla Versus Single Flap Technique In The Reconstruction Of Intrabony Defect
Official Title
Non - Incised Papilla Versus Single Flap Technique In The Reconstruction Of Intrabony Defect: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
August 7, 2024 (Anticipated)
Study Completion Date
September 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
Collaborators
Assiut University, Egyptian Russian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Attachment Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
non - Incised Papilla surgical approach NIPSA for intrabony defect
Arm Type
Experimental
Arm Description
Group I will be allocated to non - Incised Papilla surgical approach NIPSA for intrabony defect with DBBM and PRF
Arm Title
single-flap approach
Arm Type
Active Comparator
Arm Description
group II will be allocated to single-flap approach SFA for intrabony defect with DBBM and PRF
Intervention Type
Procedure
Intervention Name(s)
non - Incised Papilla surgical approach NIPSA for intrabony defect
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
single-flap approach SFA
Intervention Description
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
Primary Outcome Measure Information:
Title
interproximal clinical attachment level change
Description
CAL, measured in the interproximal space from the CEJ to the base of the pocket(BP)using a millimeter periodontal probe
Time Frame
at baseline ,6 and 12 months
Secondary Outcome Measure Information:
Title
residual probing pocket depth (PPD), pocket depth (PD) change,
Description
-Inter- proximal PD, measured in the interproximal space from the gingival margin to the BP measured by a millimeter periodontal probe
Time Frame
at at baseline ,6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa Ali, P.h.D
Phone
01003646556
Email
alaa.ali@dent.aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALAA T ALI, PhD
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
faculty of dentistry ,Assiut university
City
Assiut
ZIP/Postal Code
23145
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alaa Ali, Ph.D.
Phone
01003646556
Email
alaa.ali@dent.aun.edu.eg
First Name & Middle Initial & Last Name & Degree
Aya Ali, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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