Efficacy of Collagen Sponge on Palatal Wound Healing

August 6, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Dental Hospital of Zhejiang University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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