Comparing collagen and gelatin sponges for healing palatal wounds
Efficacy of Collagen Sponge on Palatal Wound Healing: a Randomized Controlled Clinical Trial
NA · The Dental Hospital of Zhejiang University School of Medicine · NCT05287763
This study tests whether collagen sponges or gelatin sponges help heal mouth wounds better and reduce pain after gum surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Dental Hospital of Zhejiang University School of Medicine (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05287763 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of collagen sponges versus gelatin sponges in promoting healing and reducing postoperative pain after gingival graft harvesting. Patients will be randomly assigned to receive either a collagen sponge or a gelatin sponge following their graft procedure. Pain levels will be measured using a Visual Analog Scale (VAS) at various intervals post-surgery, and wound healing will be assessed through specific tests and photographic documentation. The study will also track analgesic use and any complications such as delayed bleeding.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require gingival grafts for insufficient keratinized tissue or gingival recession.
Not a fit: Patients with smoking habits, untreated periodontal disease, or severe systemic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved healing outcomes and reduced pain for patients undergoing gingival graft procedures.
How similar studies have performed: Previous studies have shown varying success with different sponge materials in wound healing, making this approach both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Clinical indications utilizing free gingival grafts or de-epithelialized gingival grafts to treat either insufficient keratinized tissue or gingival recession defects 3. Full-mouth plaque score and full-mouth bleeding score lower than 20% Exclusion Criteria: 1. Smoking 2. Pregnancy or lactation 3. Untreated periodontal disease 4. Severe systemic conditions that contraindicate surgery (diabetes, heart disease, cancer etc.) 5. Presence of coagulation disorders (history of Haemophilia, von Wille-brand disease, or anticoagulant therapy) 6. Taking medications affecting periodontal health or healing 7. Previous surgery for a palate graft harvested from the experimental sites
Where this trial is running
Hangzhou, Zhejiang
- The Affiliated Stomatology Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Principal investigator: Peihui Ding, Doctor — The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
- Study coordinator: Weida Li, master
- Email: kyb@zjkq.com.cn
- Phone: 0571-87219287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gingival Recession, Inadequately Attached Gingiva