Single Stage Root Coverage for Gingival Recession With or Without Free Gingival Graft
Comparative Clinical Evaluation of Semilunar Coronally Positioned Flap Alone and Semilunar Coronally Positioned Flap in Conjunction With Free Gingival Graft for Root Coverage
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
Background and Objective: Gingival recession accounts for apical migration of the gingival margin resulting in exposure of the cementoenamel junction (CEJ) and root surface. It is a matter of concern for both patients and dental professionals, especially when exposure of the root surface is linked to deterioration in esthetic appearance and increase in dentinal hypersensitivity which leads to improvements in various surgical techniques that have been used to correct labial gingival recession defects. The present study thus was aimed to evaluate and compare the results of Semilunar Coronally Positioned Flap alone and Semilunar Coronally Positioned Flap in Conjunction with Free Gingival Graft for treatment of Miller Class I and II gingival recession defects in maxillary anterior teeth. Materials and Method: A total of 20 bilateral Miller's class I and II gingival recession sites in systemically healthy subjects, 20-45 years of age were recruited for this study. Recession sites were divided and randomly allocated to either of the two groups SCPF+FGG (test group) and SCPF (control group) with 10 sites per group to be treated with semilunar coronally positioned flap with free gingival graft technique for SCPF+FGG group and semilunar coronally positioned flap technique alone for SCPF group. Longitudinal alterations during a follow-up period of 1, 3, 6 and 12 months in terms of Probing depth (PD), Recession width (RW), Recession height (RH), Width of keratinized tissue (WKT) and Clinical attachment level (CAL) were measured for both the groups and the values were statistically analysed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2015
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
February 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 2, 2017
CompletedFirst Posted
Study publicly available on registry
December 12, 2017
CompletedResults Posted
Study results publicly available
March 11, 2020
CompletedMarch 11, 2020
March 1, 2020
1.6 years
December 2, 2017
April 11, 2018
March 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Recession Height
measured from cemento enamel junction to the most apical part of gingival margin
12 months
Width of Keratinized Tissue
measured from most apical part of gingival recession to the mucogingival junction
12 months
Secondary Outcomes (3)
Clinical Attachment Level
12 months
Probing Depth
12 months
Recession Width
12 months
Study Arms (2)
Semilunar Coronally Positiones Flap + Free Gingival Graft
ACTIVE COMPARATORsemilunar coronally positioned flap with free gingival graft for root coverage
Semilunar Coronally Positioned Flap
SHAM COMPARATORsemilunar coronally positioned flap alone without free gingival graft for root coverage
Interventions
Eligibility Criteria
You may qualify if:
- Bilateral Miller Class I and II gingival recessions in maxillary anterior teeth
You may not qualify if:
- systemic conditions known to interfere with periodontal healing
- history of addiction or drinking alcohol
- Systemic or local bone diseases
- Pregnancy and lactating females
- using anticoagulant or immune suppressor drugs
- the patients who are unable to maintain oral hygiene
- presence of Type II and V caries and
- smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The stabilisation of the donor graft with sutures over the recipient bed as it requires exceedingly small section of donor tissue. FGG placed apical to the flap may undergo shrinkage affecting the root coverage on long term.
Results Point of Contact
- Title
- Dr. Raga Bindu
- Organization
- Kamineni Institute of dental sciences
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Post Graduate
Study Record Dates
First Submitted
December 2, 2017
First Posted
December 12, 2017
Study Start
February 14, 2015
Primary Completion
October 7, 2016
Study Completion
November 1, 2016
Last Updated
March 11, 2020
Results First Posted
March 11, 2020
Record last verified: 2020-03