Clinical trial NCT05287763: Efficacy of Collagen Sponge on Palatal Wound Healing
Official title: Efficacy of Collagen Sponge on Palatal Wound Healing: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Recession
Inadequately Attached Gingiva
Lead sponsor: The Dental Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: epithelialization of the palatal wound evaluated by hydrogen peroxide test
timeFrame: at 1 week
measure: epithelialization of the palatal wound evaluated by hydrogen peroxide test
timeFrame: at 2 weeks
measure: epithelialization of the palatal wound evaluated by hydrogen peroxide test
timeFrame: at 3 weeks
measure: epithelialization of the palatal wound evaluated by hydrogen peroxide test
timeFrame: at 1 month
measure: epithelialization of the palatal wound evaluated by digital photography
timeFrame: at 1 week
measure: epithelialization of the palatal wound evaluated by digital photography
timeFrame: at 2 weeks
measure: epithelialization of the palatal wound evaluated by digital photography
timeFrame: at 3 weeks
measure: epithelialization of the palatal wound evaluated by digital photography
timeFrame: at 1 month
Secondary outcomes:
measure: postoperative pain
timeFrame: at day 1
measure: postoperative pain
timeFrame: at day 3
measure: postoperative pain
timeFrame: at day 7
measure: consumption of analgesics
timeFrame: at 1 week
measure: willingness to repeat the treatment
timeFrame: at 1 week
measure: the existence of delayed bleeding
timeFrame: at 1 week
measure: aesthetic score
timeFrame: at 3 weeks
measure: aesthetic score
timeFrame: at 1 month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
name: Peihui Ding, Doctor
role: PRINCIPAL_INVESTIGATOR
References: