The Use of Flowable Resin Composite Stent in Reduction of Donor Site Morbidity After Free Gingival Graft Harvesting
Clinical Comparison of the Use of Flowable Resin Composite Stent Versus Periodontal Pack to Reduce Donor Site Morbidity After Free Gingival Graft Harvesting: A Randomized Clinical Trial
1 other identifier
interventional
34
1 country
1
Brief Summary
After harvesting free gingival graft from the hard palate, Postoperative pain as well as bleeding are the most common complications.Different agents were used to protect the denuded areas on the palate as gelatin sponge, Hyaluronic acid gel and platelet rich fibrin (PRF) but still no gold standard material is present. PICO format: P: patients with mucogingival problems in need for free gingival graft or de-epithelialized connective tissue graft.I: Flowable resin composite stent. C: Periodontal pack. O: Post-operative pain T: day 3, 7, 14, 21 and 42 postoperative. Aim of the study: To compare the effect of flowable composite stent versus periodontal pack applied to palatal donor site after free gingival graft harvesting in terms of post-operative pain reduction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2023
CompletedFirst Submitted
Initial submission to the registry
February 25, 2023
CompletedFirst Posted
Study publicly available on registry
March 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2023
CompletedMarch 22, 2023
March 1, 2023
9 months
February 25, 2023
March 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post operative pain
Pain score reported by the patient directly through Visual Analogue Scale score (between 0 and 100. 0: no pain, 10: minimal pain, 50:moderate pain, 100: severe pain)
on day 7
Secondary Outcomes (2)
Color match
On day 42
wound size
at day 21
Study Arms (2)
Flowable resin composite stent group
EXPERIMENTALFlowable resin composite is a bio compatible material used in dental field many years ago.
Periodontal pack group
ACTIVE COMPARATORNon eugenol containing periodontal pack used in periodontal surgeries to protect the wound. Other name :COE\_PAK
Interventions
Flowble resin composite is a filling material used in operative dentistry and characterized by being flow and easily adapting the surfaces.
Non eugenol containing dressing supplied in two tubes
Eligibility Criteria
You may qualify if:
- Patients with mucogingival defects scheduled for free gingival graft or de-epithelialized connective tissue graft.
- Systemically healthy
You may not qualify if:
- Smokers
- Occlusal trauma at site of graft
- Pregnancy and lactation
- Patients allergic to the used agents
- Severe gagging reflex
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of dentistry, Cairo univesity
Cairo, Manial, 11, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- demonstrator
Study Record Dates
First Submitted
February 25, 2023
First Posted
March 22, 2023
Study Start
February 15, 2023
Primary Completion
November 8, 2023
Study Completion
December 5, 2023
Last Updated
March 22, 2023
Record last verified: 2023-03