Actively Recruiting
Efficacy of Collagen Sponge on Palatal Wound Healing: a Randomized Controlled Clinical Trial
Led by The Dental Hospital of Zhejiang University School of Medicine · Updated on 2024-08-07
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare how well collagen sponge and gelatin sponge help heal the palatal wound and reduce pain after gingival graft harvesting, a procedure done for gingival recession and insufficient attached gingiva. The study includes adult patients who need free or de-epithelialized gingival grafts and have good oral hygiene. Patients will be randomly assigned to one of two treatment groups to evaluate and compare outcomes. Participants will be divided into two groups where one group’s palatal wounds will be treated with an absorbable gelatin sponge stabilized by non-resorbable sutures, while the other group will receive a collagen sponge under similar conditions. The study will assess postoperative pain using a visual analog scale (VAS) at days 1, 3, and 7 after surgery. Epithelialization of the wound will be examined using hydrogen peroxide tests and digital photography at 1, 2, and 3 weeks, and again at 1 month. Additional evaluations include consumption of pain medication, willingness to repeat treatment, delayed bleeding, and aesthetic scores. During the study, participants will undergo regular assessments of wound healing and pain through tests and photographs across several weeks. Researchers will monitor pain levels, bleeding, analgesic use, and patient satisfaction with treatment. The total follow-up period includes evaluations up to one month after surgery to observe healing progress and aesthetic outcomes. The study uses a randomized, double-blind design to ensure unbiased comparison of the two sponges' effects on healing and comfort.
CONDITIONS
Brief Title
Efficacy of Collagen Sponge on Palatal Wound Healing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Need for free gingival grafts or de-epithelialized gingival grafts to treat insufficient keratinized tissue or gingival recession
- Full-mouth plaque score and full-mouth bleeding score under 20%
You will not qualify if you...
- Smoking
- Pregnancy or breastfeeding
- Untreated periodontal disease
- Severe systemic conditions that prevent surgery (e.g., diabetes, heart disease, cancer)
- Bleeding disorders or blood-thinning treatments
- Medications affecting gum health or healing
- Previous surgery at the graft harvest site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo palatal soft tissue graft harvesting surgery. The palatal wound will be protected with either a collagen sponge or a gelatin sponge, depending on group assignment.
1 surgery visit
Duration - 1 month
Participants are assessed for postoperative pain, consumption of analgesics, wound epithelialization, delayed bleeding, and aesthetic outcomes following surgery.
Visits on Day 1, Day 3, Day 7, Week 1, Week 2, Week 3, and 1 month after surgery
Trial Site Locations
Total: 1 location
1
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
W
Weida Li, master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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