Efficacy of Collagen Sponge on Palatal Wound Healing

September 14, 2023 updated by: Peihui Ding, The Dental Hospital of Zhejiang University School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Weida Li, master
  • Phone Number: 0571-87219287
  • Email: kyb@zjkq.com.cn

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gelatin Sponge
The palatal wound will be protected with an absorbable gelatin sponge, which will be stabilized by non-resorbable sling sutures.
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.
Experimental: Collagen Sponge
The palatal wound will be protected with a collagen sponge, which will be stabilized by non-resorbable sling sutures.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
epithelialization of the palatal wound evaluated by hydrogen peroxide test
Time Frame: at 1 week
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
epithelialization of the palatal wound evaluated by hydrogen peroxide test
Time Frame: at 2 weeks
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
epithelialization of the palatal wound evaluated by hydrogen peroxide test
Time Frame: at 3 weeks
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
epithelialization of the palatal wound evaluated by hydrogen peroxide test
Time Frame: 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).
at 1 month
epithelialization of the palatal wound evaluated by digital photography
Time Frame: at 1 week
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
epithelialization of the palatal wound evaluated by digital photography
Time Frame: at 2 weeks
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
epithelialization of the palatal wound evaluated by digital photography
Time Frame: at 3 weeks
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
epithelialization of the palatal wound evaluated by digital photography
Time Frame: 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.
at 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: at day 1
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
at day 1
postoperative pain
Time Frame: at day 3
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
at day 3
postoperative pain
Time Frame: at day 7
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
at day 7
consumption of analgesics
Time Frame: at 1 week
to answer the following question: Did you take any analgesics due to the palatal pain since the procedure was completed?
at 1 week
willingness to repeat the treatment
Time Frame: at 1 week
using a VAS ranging from 0 to 10 (0 = strong unwilling and 10 = strong willing)
at 1 week
the existence of delayed bleeding
Time Frame: at 1 week
the occurrence of prolonged hemorrhaging during the first week
at 1 week
aesthetic score
Time Frame: at 3 weeks
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
aesthetic score
Time Frame: 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).
at 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Dental Hospital of Zhejiang University School of Medicine

Investigators

  • Principal Investigator: Peihui Ding, Doctor, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2022

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHZhejiangU-2022(024)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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