Efficacy of Collagen Sponge on Palatal Wound Healing

The Dental Hospital of Zhejiang University School of Medicine

Status: Enrolling

Conditions: Gingival Recession; Inadequately Attached Gingiva

Treatments: Procedure: Palatal soft tissue graft harvesting

Study type: Interventional

Funder types: Other

Identifiers

NCT05287763

DHZhejiangU-2022(024)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Gelatin Sponge

Active Comparator group

Description:

The palatal wound will be protected with an absorbable gelatin sponge, which will be stabilized by non-resorbable sling sutures.

Treatment:

Procedure: Palatal soft tissue graft harvesting

Collagen Sponge

Experimental group

Description:

The palatal wound will be protected with a collagen sponge, which will be stabilized by non-resorbable sling sutures.

Treatment:

Procedure: Palatal soft tissue graft harvesting