Efficacy of Collagen Sponge on Palatal Wound Healing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Palatal soft tissue graft harvesting.
- Who it may be relevant to
- Registry conditions: Gingival Recession, Inadequately Attached Gingiva. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Collagen Sponge on Palatal Wound Healing: a Randomized Controlled Clinical Trial
Overview
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.
Detailed description
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. The included patients will be randomized into two groups. The patients in control group will be treated with gelatin sponge and those in the test group will be treated with collagen sponge. The postoperative pain will be assessed by VAS scale at day 1, 3 and 7 after surgery. Epithelialization of the palatal wound will be evaluated by hydrogen peroxide test and digital photography at 1 week postoperatively. Additionally, postoperative pain, consumption of analgesics, willingness to repeat the treatment and the existence of delayed bleeding will be recorded at 1 week. At 2 weeks, 3 weeks and 1 month after surgery, epithelialization of the palatal wound and aesthetic scores will be evaluated.
Interventions
- Procedure Palatal soft tissue graft harvesting
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.
Primary outcome measures
- epithelialization of the palatal wound evaluated by hydrogen peroxide test [Time frame: at 1 week]
- epithelialization of the palatal wound evaluated by hydrogen peroxide test [Time frame: at 2 weeks]
- epithelialization of the palatal wound evaluated by hydrogen peroxide test [Time frame: at 3 weeks]
- epithelialization of the palatal wound evaluated by hydrogen peroxide test [Time frame: at 1 month]
- epithelialization of the palatal wound evaluated by digital photography [Time frame: at 1 week]
- epithelialization of the palatal wound evaluated by digital photography [Time frame: at 2 weeks]
- epithelialization of the palatal wound evaluated by digital photography [Time frame: at 3 weeks]
- epithelialization of the palatal wound evaluated by digital photography [Time frame: at 1 month]
Secondary outcome measures (8)
- postoperative pain [Time frame: at day 1]
- postoperative pain [Time frame: at day 3]
- postoperative pain [Time frame: at day 7]
- consumption of analgesics [Time frame: at 1 week]
- willingness to repeat the treatment [Time frame: at 1 week]
- the existence of delayed bleeding [Time frame: at 1 week]
- aesthetic score [Time frame: at 3 weeks]
- aesthetic score [Time frame: at 1 month]
Eligibility criteria
Inclusion criteria
- 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%
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Affiliated Stomatology Hospital of Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT05287763 · DHZhejiangU-2022(024)