Alveogyl and Gelatin Sponge in the Management of Pain After Epithelialized Free Gingival Graft Harvesting
Clinical Comparison of Alveogyl and Gelatin Sponge in the Management of Pain After Epithelialized Free Gingival Graft Harvesting: A Randomized Clinical Trial
1 other identifier
interventional
36
0 countries
N/A
Brief Summary
clinical comparison between alvogyl and gelatin sponge when used to protect the denuded area of the palatal donor site after free gingival graft in means of reducing pain and healing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2019
Shorter than P25 for phase_4
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
December 27, 2017
CompletedFirst Posted
Study publicly available on registry
January 18, 2018
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedFebruary 8, 2019
February 1, 2019
2 months
December 27, 2017
February 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain score
recorded by the pain trough a Visual Analogue scale score (between 0 and 10. 0: no pain, 1: minimal pain,10: severe pain)
2 weeks
Secondary Outcomes (3)
healing
4 weeks
bleeding
2 weeks
analgesic consumption
2 weeks
Study Arms (2)
control group
ACTIVE COMPARATORGelatin Sponge Sheet is a heamostatic agent act as a mechanical barrier to protect the palatal donor site
intervention group
EXPERIMENTALalvogyl in a paste form with analgesic action to protect the palatal donor site and help to relief pain
Interventions
sheets act as a mechanical barrier used to protect the denuded area of the palatal donor site
paste form with analgesic action to protect the palatal donor site and help to relief pain
Eligibility Criteria
You may qualify if:
- Patients scheduled for different periodontal and peri-implant plastic surgeries requiring palatal mucosal graft harvesting
- Systemically healthy
You may not qualify if:
- Severe gagging reflex
- Smokers
- Occlusal trauma at site of graft
- Pregnancy
- Psychiatric disorder
- Patients allergic to the used agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Ehab K, Abouldahab O, Hassan A, Fawzy El-Sayed KM. Alvogyl and absorbable gelatin sponge as palatal wound dressings following epithelialized free gingival graft harvest: a randomized clinical trial. Clin Oral Investig. 2020 Apr;24(4):1517-1525. doi: 10.1007/s00784-020-03254-z. Epub 2020 Mar 6.
PMID: 32144515DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 27, 2017
First Posted
January 18, 2018
Study Start
April 1, 2019
Primary Completion
June 1, 2019
Study Completion
July 1, 2019
Last Updated
February 8, 2019
Record last verified: 2019-02