Effect of Hyaluronic Acid on Oral Mucosal Wound Healing - Focus on Pain and Re-epithelisation

July 2, 2023 updated by: Andreas Stavropoulos, Malmö University
Establishment of a sufficiently wide and thick keratinized gingival/mucosal tissue cuff around teeth/implants is considered of importance for long-term stability. This can more readily be achieved by means of autogenous soft tissue grafts harvested from the palate than with soft tissue substitutes. However, this often implies the creation of an open palatal wound involving secondary intention healing. The aim of this randomized controlled, split-mouth, clinical trial is to assess the effect of a hyaluronic acid containing commercial product on wound healing and patient morbidity after palatal soft tissue harvesting. Altogether, 20 volunteers will be recruited. An individualized splint containing 2 symmetrically located contralateral cylindrical openings will be used for standardized soft tissue harvesting (6 mm in Ø, 2 mm in depth). Soft tissue grafts will be harvested randomly from the right or left side and patients will be monitored for 3 weeks followed by a 1-month wash-out period prior to harvesting the second soft tissue graft from the other side. Participants will randomly start treating the palatal wound either with the test product (GUM Aftaclear Gel, Sunstar Suisse SA, Etoy, Switzerland; 0.3%) or saline solution for 7 days to promote the healing process, which will be reversed for the second round. Patient-related outcomes (morbidity, discomfort, taste alteration, pain killer consumption), frequency of bleeding events, defect closure (area, volume), and microbial colonisation will be recorded and analysed for any differences between the control and test product. Further, in 6 additional volunteers, biopsies of the healing wound are collected in a similar fashion as described above, but with the use of a larger stent in order to harvest also pristine surrounding tissues for histological analysis; biopsies are collected up to 14 days of healing.

Study Overview

Status

Status

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

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.

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 (Actual)

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.
25

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 Locations

  • Sweden
      • Malmo, Sweden
        • Faculty of Odontology, Malmo University

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18-65 years,
  • systemically healthy,
  • healthy periodontal conditions at the experimental region or conditions not interfering with proper biopsy harvesting,
  • no known sensitivity to HY,
  • no uncontrolled diabetes mellitus,
  • no radiotherapy or chemotherapy,
  • no current pregnancy or breastfeeding,
  • no hormonal diseases,
  • no infectious diseases,
  • no autoimmune diseases or under immunotherapy,
  • no systemic bone disease,
  • no wound healing disorders or acute inflammatory/infectious processes,
  • no systemic diseases with implications on mucous membranes (e.g., Morbus Crohn),
  • no increased risk of bleeding (i.e., patient with coagulation disorders or under anticoagulant therapy, and
  • no heavy smokers (i.e., no regular tobacco consumption > 10 cigarettes/day).

Exclusion Criteria:

  • not meeting the inclusion criteria.

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: Crossover 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.
Experimental: Hyaluronic acid
Application 3-times per day for 7 days.
Procedure: palatal soft tissue harvesting
A 6x2mm palatal soft tissue graft will be harvested.
Device: Hyaluronic acid
application 3-times per day for 7 days
Placebo Comparator: Saline solution
Application 3-times per day for 7 days.
Procedure: palatal soft tissue harvesting
A 6x2mm palatal soft tissue graft will be harvested.
Other: Saline solution (placebo)
application 3-times per day for 7 days

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
pain / discomfort (burning) perception by means of a 100 mm VAS
Time Frame: 3 days
0 indicates no pain, 100 indicates maximum pain
3 days
pain / discomfort (burning) perception by means of a 100 mm VAS
Time Frame: 7 days
0 indicates no pain, 100 indicates maximum pain
7 days
pain / discomfort (burning) perception by means of a 100 mm VAS
Time Frame: 14 days
0 indicates no pain, 100 indicates maximum pain
14 days
pain / discomfort (burning) perception by means of a 100 mm VAS
Time Frame: 21 days
0 indicates no pain, 100 indicates maximum pain
21 days

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
pain killer consumption
Time Frame: 3 days
amount of pills taken
3 days
pain killer consumption
Time Frame: 7 days
amount of pills taken
7 days
pain killer consumption
Time Frame: 14 days
amount of pills taken
14 days
pain killer consumption
Time Frame: 21 days
amount of pills taken
21 days
disturbance while eating or drinking by means of a 100 mm VAS
Time Frame: 3 days
0 indicates no disturbance, 100 indicates maximum disturbance
3 days
disturbance while eating or drinking by means of a 100 mm VAS
Time Frame: 7 days
0 indicates no disturbance, 100 indicates maximum disturbance
7 days
disturbance while eating or drinking by means of a 100 mm VAS
Time Frame: 14 days
0 indicates no disturbance, 100 indicates maximum disturbance
14 days
disturbance while eating or drinking by means of a 100 mm VAS
Time Frame: 21 days
0 indicates no disturbance, 100 indicates maximum disturbance
21 days
taste alteration experience by means of a 100 mm VAS
Time Frame: 3 days
0 indicates no alteration, 100 indicates maximum alteration
3 days
taste alteration experience by means of a 100 mm VAS
Time Frame: 7 days
0 indicates no alteration, 100 indicates maximum alteration
7 days
taste alteration experience by means of a 100 mm VAS
Time Frame: 14 days
0 indicates no alteration, 100 indicates maximum alteration
14 days
taste alteration experience by means of a 100 mm VAS
Time Frame: 21 days
0 indicates no alteration, 100 indicates maximum alteration
21 days
frequency of re-bleeding
Time Frame: 3 days
number of events
3 days
frequency of re-bleeding
Time Frame: 7 days
number of events
7 days
frequency of re-bleeding
Time Frame: 14 days
number of events
14 days
frequency of re-bleeding
Time Frame: 21 days
number of events
21 days
re-epithelialised defect area (by means of standardized photographs)
Time Frame: 3 days
mm2
3 days
re-epithelialised defect area (by means of standardized photographs)
Time Frame: 7 days
mm2
7 days
re-epithelialised defect area (by means of standardized photographs)
Time Frame: 14 days
mm2
14 days
re-epithelialised defect area (by means of standardized photographs)
Time Frame: 21 days
mm2
21 days
re-epithelisation by colorimetric digital assessment of the calibrated photographs
Time Frame: 3 days
colorimetric assessment
3 days
re-epithelisation by colorimetric digital assessment of the calibrated photographs
Time Frame: 7 days
colorimetric assessment
7 days
re-epithelisation by colorimetric digital assessment of the calibrated photographs
Time Frame: 14 days
colorimetric assessment
14 days
re-epithelisation by colorimetric digital assessment of the calibrated photographs
Time Frame: 21 days
colorimetric assessment
21 days
changes in total and specific bacterial counts
Time Frame: 3 days
log values
3 days
changes in total and specific bacterial counts
Time Frame: 7 days
log values
7 days
changes in total and specific bacterial counts
Time Frame: 14 days
log values
14 days
defect volume fill by overlay of the intraoral scans
Time Frame: 3 days
mm3
3 days
defect volume fill by overlay of the intraoral scans
Time Frame: 7 days
mm3
7 days
defect volume fill by overlay of the intraoral scans
Time Frame: 14 days
mm3
14 days
defect volume fill by overlay of the intraoral scans
Time Frame: 21 days
mm3
21 days
food restrictions (yes/no)
Time Frame: 3 days
3 days
food restrictions (yes/no)
Time Frame: 7 days
7 days
food restrictions (yes/no)
Time Frame: 14 days
14 days
food restrictions (yes/no)
Time Frame: 21 days
21 days

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.
Malmö University

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.
January 10, 2022

Primary Completion (Actual)

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.
May 31, 2023

Study Completion (Actual)

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.
May 31, 2023

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).
October 9, 2021

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.
October 21, 2021

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.
October 29, 2021

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.
July 5, 2023

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.
July 2, 2023

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.
July 1, 2023

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.
  • 2020-01018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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