Periosteal Pedicle Flap Versus Subepithelial Connective Tissue Graft in Management of Gingival Recession
Can a Periosteal Pedicle Flap Replace the Subepithelial Connective Tissue Graft in the Management of Gingival Recession? Randomized Controlled Clinical Trial
1 other identifier
interventional
10
0 countries
N/A
Brief Summary
Gingival recession is defined as the apical shift of the marginal gingiva from its normal position on the crown of the tooth to levels on the root surface beyond the cemento-enamel junction (CEJ).Various surgical procedures including repositioned flaps as well as autogenous and other type grafts have been used in the treatment of gingival recession.The present gold standard technique is the bilaminar technique using the subepithelial connective tissue graft (SCTG) which provides for long-term stability but also increases tissue morbidity.Hence, a suitable alternative technique - the periosteal pedicle flap (PPF) - has been practiced, which is less invasive, does not require a second surgical site, and provides a graft of adequate dimensions.
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 Aug 2024
Shorter than P25 for not_applicable
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
July 26, 2024
CompletedFirst Posted
Study publicly available on registry
July 31, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedJuly 31, 2024
July 1, 2024
3 months
July 26, 2024
July 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
the percentage of root coverage (%RC)
to measure the coverage percentage of root recession by UNC periodontal probe Preoperative recession depth - Postoperative recession depth /Preoperative recession depth x 100
at base line, 1 month and 3 months after treatment
Secondary Outcomes (4)
recession depth
at base line, 1 month and 3 months after treatment
recession width
at base line, 1 month and 3 months after treatment
clinical attachment gain
at base line, 1 month and 3 months after treatment
keratinized tissue gain
at base line, 1 month and 3 months after treatment
Study Arms (2)
Subepothelial connective tissue graft (SCTG) group
ACTIVE COMPARATORSubepithelial connective tissue graft from palate then coronally positioning flap to cover root recession
Periosteal pedicle flap (PPF) group
ACTIVE COMPARATORperiosteal flap elevation and repositioning to the root then coronally positioning flap to cover root recession
Interventions
The SCTG will be harvested from the palate followed by coronally postionting flap
he periosteal pedicle graft obtained is then turned over the exposed root surface then followed by coronally postionting flap
Eligibility Criteria
You may qualify if:
- Patients with one or more Miller's Class 1 and Class II buccal recessions demonstrating ≤20% of plaque and bleeding scores, respectively, after Phase I therapy.
- age from 18 th 60 years.
You may not qualify if:
- Smokers
- patients with malposed or crowded teeth
- pregnant and lactating women
- patients using medications that could affect the periodontal status
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer, Oral medicine, Periodontology and Oral diagnosis, Faculty of dentistry
Study Record Dates
First Submitted
July 26, 2024
First Posted
July 31, 2024
Study Start
August 1, 2024
Primary Completion
November 1, 2024
Study Completion
November 1, 2024
Last Updated
July 31, 2024
Record last verified: 2024-07