Efficacy of Collagen Sponge on Palatal Wound Healing

Not Applicable

Recruiting

• Conditions: Gingival Recession; Inadequately Attached Gingiva
• Interventions: Procedure: Palatal soft tissue graft harvesting

• Registration Number: NCT05287763
• Lead Sponsor: The Dental Hospital of Zhejiang University School of Medicine

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.

Study Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-18
• Study Start: 2022-04-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gelatin Sponge	Palatal soft tissue graft harvesting	The palatal wound will be protected with an absorbable gelatin sponge, which will be stabilized by non-resorbable sling sutures.
Collagen Sponge	Palatal soft tissue graft harvesting	The palatal wound will be protected with a collagen sponge, which will be stabilized by non-resorbable sling sutures.

Primary Outcome Measures

Name	Time	Method
epithelialization of the palatal wound evaluated by hydrogen peroxide test	at 1 month	The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
epithelialization of the palatal wound evaluated by digital photography	at 1 month	The epithelialization of the palatal wound will be recorded as "yes" or "no" according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline.

Secondary Outcome Measures

Name	Time	Method
consumption of analgesics	at 1 week	to answer the following question: Did you take any analgesics due to the palatal pain since the procedure was completed?
willingness to repeat the treatment	at 1 week	using a VAS ranging from 0 to 10 (0 = strong unwilling and 10 = strong willing)
the existence of delayed bleeding	at 1 week	the occurrence of prolonged hemorrhaging during the first week
postoperative pain	at day 7	using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
aesthetic score	at 1 month	assessed by judging on the color, contour, and texture of the donor sites. The total score will vary between 0 and 6 by scoring each subject from 0 to 2 (0=inharmonious with adjacent tissue, 1=moderately harmonious with adjacent tissue and 2=very harmonious with adjacent tissue).

Trial Locations

Locations (1)

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China