Treatment of Gingival Recession Using Gingival Composite Restoration Versus Coronally Advanced Flap
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
Treatment of gingival recession requires favourable anatomical conditions and the use of invasive surgical approaches. Hence, these procedures are not always indicated in all cases and can cause great pain and morbidity. Coloured composite restorations that mimic the lost gingival tissues can provide a non-invasive and simple solution regardless of the recession soft and hard-tissue conditions.
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 Oct 2021
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
First Submitted
Initial submission to the registry
October 3, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedOctober 14, 2020
October 1, 2020
12 months
October 3, 2020
October 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
post-operative pain
self-reported pain on visual analogue scale (VAS)
7 days
Secondary Outcomes (9)
post-operative pain
1,3,5,14 days
overall quality of life: questionnaire
6 months
Reported post-operative satisfaction
6 months
mean root coverage
6 months
complete root coverage
6 months
- +4 more secondary outcomes
Study Arms (2)
Treatment of gingival recession with colored composite
EXPERIMENTALComposite restoration will be applied to the gingival recession defect
Treatment of gingival recession with coronally advanced flap
ACTIVE COMPARATORcoronally advanced flap at the gingival defect
Interventions
flap surgery to achieve root coverage at gingival recession defect
colored composite restoration to camouflage the gingival recession defect
Eligibility Criteria
You may qualify if:
- participants with at least one buccal gingival recession
- O'Leary plaque index less than 20%
- motivated participants willing to complete the follow up
You may not qualify if:
- prior surgical or restorative interventions at the recession defect
- smokers
- pregnant participants
- systemic conditions contraindicating dental management
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Karim Fawzy El-Sayed, PhD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
October 3, 2020
First Posted
October 14, 2020
Study Start
October 1, 2021
Primary Completion
September 30, 2022
Study Completion
December 30, 2022
Last Updated
October 14, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share