Efficacy of Collagen Sponge on Palatal Wound Healing
1 other identifier
interventional
32
1 country
1
Brief Summary
The aim of this study is to compare the efficacy of collagen sponge and gelatin sponge on the palatal wound healing and postoperative pain following gingival graft harvesting.
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 Apr 2022
Longer than P75 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
First Submitted
Initial submission to the registry
February 28, 2022
CompletedFirst Posted
Study publicly available on registry
March 18, 2022
CompletedStudy Start
First participant enrolled
April 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedAugust 7, 2024
August 1, 2024
4 years
February 28, 2022
August 6, 2024
Conditions
Outcome Measures
Primary Outcomes (8)
epithelialization of the palatal wound evaluated by hydrogen peroxide test
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
at 1 week
epithelialization of the palatal wound evaluated by hydrogen peroxide test
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
at 2 weeks
epithelialization of the palatal wound evaluated by hydrogen peroxide test
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
at 3 weeks
epithelialization of the palatal wound evaluated by hydrogen peroxide test
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
at 1 month
epithelialization of the palatal wound evaluated by digital photography
The epithelialization of the palatal wound will be recorded as "yes" or "no" according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline.
at 1 week
epithelialization of the palatal wound evaluated by digital photography
The epithelialization of the palatal wound will be recorded as "yes" or "no" according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline.
at 2 weeks
epithelialization of the palatal wound evaluated by digital photography
The epithelialization of the palatal wound will be recorded as "yes" or "no" according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline.
at 3 weeks
epithelialization of the palatal wound evaluated by digital photography
The epithelialization of the palatal wound will be recorded as "yes" or "no" according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline.
at 1 month
Secondary Outcomes (8)
postoperative pain
at day 1
postoperative pain
at day 3
postoperative pain
at day 7
consumption of analgesics
at 1 week
willingness to repeat the treatment
at 1 week
- +3 more secondary outcomes
Study Arms (2)
Gelatin Sponge
ACTIVE COMPARATORThe palatal wound will be protected with an absorbable gelatin sponge, which will be stabilized by non-resorbable sling sutures.
Collagen Sponge
EXPERIMENTALThe palatal wound will be protected with a collagen sponge, which will be stabilized by non-resorbable sling sutures.
Interventions
After local anaesthesia, a horizontal incision 2 mm apically from the gingival margin will be carried out using a #15C blade. The standardized rectangular graft with a thickness of 1.5 mm will be harvested from distal aspect of canine till first molar. The graft will be lifted and separated using tissue forceps and a blade till it is free from all sides.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Clinical indications utilizing free gingival grafts or de-epithelialized gingival grafts to treat either insufficient keratinized tissue or gingival recession defects
- Full-mouth plaque score and full-mouth bleeding score lower than 20%
You may not qualify if:
- Smoking
- Pregnancy or lactation
- Untreated periodontal disease
- Severe systemic conditions that contraindicate surgery (diabetes, heart disease, cancer etc.)
- Presence of coagulation disorders (history of Haemophilia, von Wille-brand disease, or anticoagulant therapy)
- Taking medications affecting periodontal health or healing
- Previous surgery for a palate graft harvested from the experimental sites
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peihui Ding, Doctor
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Central Study Contacts
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
- Deputy Chief Physician
Study Record Dates
First Submitted
February 28, 2022
First Posted
March 18, 2022
Study Start
April 30, 2022
Primary Completion
April 30, 2026
Study Completion
April 30, 2026
Last Updated
August 7, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share