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Non-Incised Papilla Flap in Deep Supraossous Defects

Primary Purpose

Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Non-incised papila surgical approach only
Non-incised papila surgical approach with connective tissue grafting
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

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

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.

Sites / Locations

  • Ain Shams University- Russian University in EgyptRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NIPSA in deep supra-alveolar defects without connective tissue graft

NIPSA in deep supra-alveolar defects with connective tissue graft

Arm Description

Outcomes

Primary Outcome Measures

interproximal clinical attachment level gain
measured from CEJ to base of pocket depth by using periodontal prob

Secondary Outcome Measures

residual pocket depth
distance from gingival margin to pocket depth by using periodontal prob

Full Information

First Posted
May 1, 2023
Last Updated
May 9, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05864989
Brief Title
Non-Incised Papilla Flap in Deep Supraossous Defects
Official Title
Non-Incised Papilla Flap With and Without Connective Tissue Graft for Management of Deep Supraossous Defects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NIPSA in deep supra-alveolar defects without connective tissue graft
Arm Type
Experimental
Arm Title
NIPSA in deep supra-alveolar defects with connective tissue graft
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Non-incised papila surgical approach only
Intervention Description
Reconstructive periodontal surgery
Intervention Type
Procedure
Intervention Name(s)
Non-incised papila surgical approach with connective tissue grafting
Intervention Description
Reconstructive periodontal surgery
Primary Outcome Measure Information:
Title
interproximal clinical attachment level gain
Description
measured from CEJ to base of pocket depth by using periodontal prob
Time Frame
6 MONTHS
Secondary Outcome Measure Information:
Title
residual pocket depth
Description
distance from gingival margin to pocket depth by using periodontal prob
Time Frame
6 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahetab mohamed A Wahab, PhD
Phone
01115554490
Email
mahetabmohamed@dent.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mahetab mohamed A Wahab
Phone
01005251611
Email
mahetabmohamed@dent.asu.edu.eg
Facility Information:
Facility Name
Ain Shams University- Russian University in Egypt
City
Cairo
State/Province
Al Qahirah
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahetab mohamed A Wahab, PhD
Phone
01115554490
Email
mahetabmohamed@dent.asu.edu.eg
First Name & Middle Initial & Last Name & Degree
Mahetab mohamed A Wahab
Phone
01005251611
Email
mahetabmohamed@dent.asu.edu.eg
First Name & Middle Initial & Last Name & Degree
AYA ALI, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Non-Incised Papilla Flap

Learn more about this trial

Non-Incised Papilla Flap in Deep Supraossous Defects

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