NCT04255888

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

June 4, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

February 3, 2020

Last Update Submit

June 2, 2020

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • Root coverage

    Root coverage as seen by Reduction in gingival recession depth and width

    6 months

Secondary Outcomes (1)

  • Location of gingival margin and periodontal status in the donor site area

    6 months

Study Arms (2)

Thick periodontal phenotype

ACTIVE COMPARATOR

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

Procedure: Laterally positioned flap in thick periodontal phenotype.

Thin periodontal phenotype

ACTIVE COMPARATOR

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

Procedure: Laterally positioned flap in thin periodontal phenotype.

Interventions

Laterally positioned flap in thick periodontal phenotype.PROCEDURE

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

Thick periodontal phenotype
Laterally positioned flap in thin periodontal phenotype.PROCEDURE

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

Thin periodontal phenotype

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Anjali kothari

    post graduate institute of dental sciences,rohtak

    PRINCIPAL INVESTIGATOR

Central Study Contacts

RAJINDER SHARMA

CONTACT

01262283876rksharmamds@yahoo.in

SHARMA

CONTACT

01262283876rksharmamds@yahoo.in

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 5, 2020

Study Start

January 1, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

June 4, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

STUDY PROTOCOL

Shared Documents
STUDY PROTOCOL

Locations

IN(1)