Efficacy of Collagen Sponge on Palatal Wound Healing

Gingival Recession Clinical Trial

Official title:

Efficacy of Collagen Sponge on Palatal Wound Healing: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05287763
• Other study ID #: DHZhejiangU-2022(024)
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: September 2023
• Source: The Dental Hospital of Zhejiang University School of Medicine
• Contact: Weida Li, master
• Phone: 0571-87219287
• Email: kyb[@]zjkq.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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.

Locations

Country	Name	City	State
China	The Affiliated Stomatology Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Dental Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	epithelialization of the palatal wound evaluated by hydrogen peroxide test	The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).	at 1 week
Primary	epithelialization of the palatal wound evaluated by hydrogen peroxide test	The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).	at 2 weeks
Primary	epithelialization of the palatal wound evaluated by hydrogen peroxide test	The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).	at 3 weeks
Primary	epithelialization of the palatal wound evaluated by hydrogen peroxide test	The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).	at 1 month
Primary	epithelialization of the palatal wound evaluated by digital photography	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.	at 1 week
Primary	epithelialization of the palatal wound evaluated by digital photography	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.	at 2 weeks
Primary	epithelialization of the palatal wound evaluated by digital photography	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.	at 3 weeks
Primary	epithelialization of the palatal wound evaluated by digital photography	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.	at 1 month
Secondary	postoperative pain	using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)	at day 1
Secondary	postoperative pain	using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)	at day 3
Secondary	postoperative pain	using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)	at day 7
Secondary	consumption of analgesics	to answer the following question: Did you take any analgesics due to the palatal pain since the procedure was completed?	at 1 week
Secondary	willingness to repeat the treatment	using a VAS ranging from 0 to 10 (0 = strong unwilling and 10 = strong willing)	at 1 week
Secondary	the existence of delayed bleeding	the occurrence of prolonged hemorrhaging during the first week	at 1 week
Secondary	aesthetic score	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).	at 3 weeks
Secondary	aesthetic score	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).	at 1 month