Periodontal Phenotype and Laterally Positioned Flap in Isolated Gingival Recession

NCT ID: NCT04255888

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-09-30

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.

Conditions

Gingival Recession

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Thick periodontal phenotype

Laterally positioned flap will be performed in isolated gingival recession belonging thick periodontal phenotype .

Group Type: ACTIVE_COMPARATOR

Laterally positioned flap in thick periodontal phenotype.

Intervention Type: PROCEDURE

Laterally positioned flap will be performed in isolated gingival recession belonging thick periodontal phenotype .

Thin periodontal phenotype

Laterally positioned flap will be performed in isolated gingival recession belonging thin periodontal phenotype .

Group Type: ACTIVE_COMPARATOR

Laterally positioned flap in thin periodontal phenotype.

Intervention Type: PROCEDURE

Laterally positioned flap will be performed in isolated gingival recession belonging thin periodontal phenotype .

Interventions

Laterally positioned flap in thick periodontal phenotype.

Laterally positioned flap will be performed in isolated gingival recession belonging thick periodontal phenotype .

Intervention Type: PROCEDURE

Laterally positioned flap in thin periodontal phenotype.

Laterally positioned flap will be performed in isolated gingival recession belonging thin periodontal phenotype .

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anjali kothari

Role: PRINCIPAL_INVESTIGATOR

post graduate institute of dental sciences,rohtak

Locations

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, India

Site Status: RECRUITING

Countries

India

Central Contacts

RAJINDER SHARMA

Role: CONTACT

rksharmamds@yahoo.in

01262283876

SHARMA

Role: CONTACT

rksharmamds@yahoo.in

01262283876

Facility Contacts

SANJAY TEWARI

Role: primary

principalpgids@yahoo.in

01262283876

Other Identifiers

Anjali perio

Identifier Type: -

Identifier Source: org_study_id