Periodontal Phenotype and Laterally Positioned Flap in Isolated Gingival Recession
Primary Purpose
Gingival Recession
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Laterally positioned flap in thick periodontal phenotype.
Laterally positioned flap in thin periodontal phenotype.
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
Eligibility Criteria
INCLUSION CRITERIA
- Isolated Miller's class I, class II, and class III gingival recession in the anterior region
- Gingival Recession depth should be ≥2mm.
- Width of keratinized gingiva ≥3 mm on the immediately adjacent tooth
EXCLUSION CRITERIA
- Patients with a history of systemic condition that might alter the course of disease and /or wound healing such as diabetes mellitus, immunologic disorders.
- Pregnant and lactating women .
- Non vital tooth
- Smokers
- Caries, cervical abrasion or restoration on the labial aspect of tooth with gingival recession.
- Periodontal surgical treatment during previous 24 months on the involved sites.
- Miller's class IV. All potential participants would be explained the need and design of study .Only those subjects who consented for the study will be included after obtaining an informed consent.
Sites / Locations
- Post Graduate Institute of Dental SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Thick periodontal phenotype
Thin periodontal phenotype
Arm Description
Laterally positioned flap will be performed in isolated gingival recession belonging thick periodontal phenotype .
Laterally positioned flap will be performed in isolated gingival recession belonging thin periodontal phenotype .
Outcomes
Primary Outcome Measures
Root coverage
Root coverage as seen by Reduction in gingival recession depth and width
Secondary Outcome Measures
Location of gingival margin and periodontal status in the donor site area
Distance from customised fabricated stent to gingival margin of donor and treated tooth
Full Information
NCT ID
NCT04255888
First Posted
February 3, 2020
Last Updated
June 2, 2020
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
1. Study Identification
Unique Protocol Identification Number
NCT04255888
Brief Title
Periodontal Phenotype and Laterally Positioned Flap in Isolated Gingival Recession
Official Title
Clinical Evaluation of the Impact of Periodontal Phenotype on the Outcome of Laterally Positioned Flap in Isolated Gingival Recession
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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 aim of this study is to estimate the effect of periodontal phenotype on the outcome of isolated gingival recession by laterally positioned flap.The primary objective of study is to assess the changes in gingival margin in the donor tooth after laterally positioned flap over a period of 6 months and to assess the influence of periodontal phenotype on the stability of results of root coverage achieved through laterally positioned flap. The secondary objective of this study is to evaluate root coverage by laterally positioned flap in thick periodontal phenotype and to evaluate root coverage by laterally positioned flap in thin periodontal phenotype.
Detailed Description
A variety of surgical techniques have been proposed to achieve successful and predictable root coverage. These include coronally advanced flap, lateral positioned flap (LPF) free gingival graft, free connective tissue graft, and guided tissue regeneration. LPF, originally described by Grupe and Warren in 1964 is one of the most commonly performed root coverage technique.The procedure has undergone various modification over the years .Staffileno and pfeifer and Heller advocated the use of split-thickness flap to minimize the potential risk for the development of recession in the donor tooth.Wood et al used re-entry procedures to compare crestal radicular bone responses to full and partial thickness flaps. They concluded that regardless of the flap procedure, loss of crestal bone depended on the periodontal phenotype.The term periodontal phenotype refers to phenotypic characteristic of bone and soft tissue that make up the periodontium. Periodontal phenotype is typically used to describe the buccolingual tissue thickness and gingival morphology. It is divided into thick flat and thin scalloped type. However there is a paucity of studies in the literature studying the effect periodontal phenotype on the root coverage obtained and its stability over time after LPF. Furthermore the impact of periodontal phenotype on the donor area in this procedure has not been explored. Therefore the present study is designed with the aim to evaluate the influence of periodontal phenotype on the outcome of root coverage by LPF.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thick periodontal phenotype
Arm Type
Active Comparator
Arm Description
Laterally positioned flap will be performed in isolated gingival recession belonging thick periodontal phenotype .
Arm Title
Thin periodontal phenotype
Arm Type
Active Comparator
Arm Description
Laterally positioned flap will be performed in isolated gingival recession belonging thin periodontal phenotype .
Intervention Type
Procedure
Intervention Name(s)
Laterally positioned flap in thick periodontal phenotype.
Intervention Description
Laterally positioned flap will be performed in isolated gingival recession belonging thick periodontal phenotype .
Intervention Type
Procedure
Intervention Name(s)
Laterally positioned flap in thin periodontal phenotype.
Intervention Description
Laterally positioned flap will be performed in isolated gingival recession belonging thin periodontal phenotype .
Primary Outcome Measure Information:
Title
Root coverage
Description
Root coverage as seen by Reduction in gingival recession depth and width
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Location of gingival margin and periodontal status in the donor site area
Description
Distance from customised fabricated stent to gingival margin of donor and treated tooth
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA
Isolated Miller's class I, class II, and class III gingival recession in the anterior region
Gingival Recession depth should be ≥2mm.
Width of keratinized gingiva ≥3 mm on the immediately adjacent tooth
EXCLUSION CRITERIA
Patients with a history of systemic condition that might alter the course of disease and /or wound healing such as diabetes mellitus, immunologic disorders.
Pregnant and lactating women .
Non vital tooth
Smokers
Caries, cervical abrasion or restoration on the labial aspect of tooth with gingival recession.
Periodontal surgical treatment during previous 24 months on the involved sites.
Miller's class IV. All potential participants would be explained the need and design of study .Only those subjects who consented for the study will be included after obtaining an informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RAJINDER SHARMA
Phone
01262283876
Email
rksharmamds@yahoo.in
First Name & Middle Initial & Last Name or Official Title & Degree
SHARMA
Phone
01262283876
Email
rksharmamds@yahoo.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anjali kothari
Organizational Affiliation
post graduate institute of dental sciences,rohtak
Official's Role
Principal Investigator
Facility Information:
Facility Name
Post Graduate Institute of Dental Sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SANJAY TEWARI
Phone
01262283876
Email
principalpgids@yahoo.in
First Name & Middle Initial & Last Name & Degree
ANJALI KOTHARI
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
STUDY PROTOCOL
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Periodontal Phenotype and Laterally Positioned Flap in Isolated Gingival Recession
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