Effectiveness of Gelatamp in Wound Healing After Teeth Extraction: A Randomized Clinical Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
This study compares the effectiveness of Gelatamp for intraoral wound closure after extraction of mandibular teeth.
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 Jul 2022
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedFirst Submitted
Initial submission to the registry
April 29, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedMay 11, 2023
May 1, 2023
9 months
April 29, 2023
May 9, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
Postoperative wound healing
A 5 point early wound healing scale assessing wound healing after 7 postoperative days
7th postoperative day
Postoperative pain
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
1st postoperative day
Postoperative pain
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
2nd postoperative day
postoperative pain
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
3rd postoperative day
postoperative pain
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
4th postoperative day
postoperative pain
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
5th postoperative day
Secondary Outcomes (1)
Presence of dry socket
3rd postoperative day
Study Arms (2)
Group A
EXPERIMENTALApplication of Gelatamp in the extraction socket
Group B
ACTIVE COMPARATORExtraction socket allowed to heal without application of Gelatamp
Interventions
Augment the extraction socket with Gelatamp
Extraction socket allowed to heal without augmentation with any material
Eligibility Criteria
You may qualify if:
- Patients requiring extraction of mandibular teeth
- Healthy patients (ASA I) or patients with mild systemic disease but no functional limitations (ASA II)
- Patients not allergic to the drugs or anesthetics used in the study.
You may not qualify if:
- Patients taking medications that influences wound healing
- smokers
- Uncooperative patients
- Patients requiring extraction of grade II or III mobile teeth
- Patients requiring surgical extraction of teeth.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Melaka Manipal Medical College
Malacca, 75150, Malaysia
Study Officials
- PRINCIPAL INVESTIGATOR
Abdul K Azad
Melaka Manipal Medical College
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
- Assistant Professor
Study Record Dates
First Submitted
April 29, 2023
First Posted
May 9, 2023
Study Start
July 1, 2022
Primary Completion
March 30, 2023
Study Completion
March 30, 2023
Last Updated
May 11, 2023
Record last verified: 2023-05