Periodontal Phenotype and Laterally Positioned Flap in Isolated Gingival Recession

Clinical Evaluation of the Impact of Periodontal Phenotype on the Outcome of Laterally Positioned Flap in Isolated Gingival Recession

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.

Study Overview

• Status: Unknown
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Laterally positioned flap in thick periodontal phenotype.; Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • Post Graduate Institute of Dental Sciences
      • Principal Investigator: ANJALI KOTHARI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Thick periodontal phenotype; Laterally positioned flap will be performed in isolated gingival recession belonging thick periodontal phenotype .	Procedure: Laterally positioned flap in thick periodontal phenotype.; Laterally positioned flap will be performed in isolated gingival recession belonging thick periodontal phenotype .
ACTIVE_COMPARATOR: Thin periodontal phenotype; Laterally positioned flap will be performed in isolated gingival recession belonging thin periodontal phenotype .	Procedure: Laterally positioned flap in thin periodontal phenotype.; Laterally positioned flap will be performed in isolated gingival recession belonging thin periodontal phenotype .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Root coverage	Root coverage as seen by Reduction in gingival recession depth and width	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Anjali kothari, Post Graduate Institute Of Dental Sciences,Rohtak

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): September 30, 2020
• Study Completion (ANTICIPATED): September 30, 2020

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: Anjali perio

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: STUDY PROTOCOL
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No