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

Primary Purpose

Soft Tissue Wound Healing

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
palatal soft tissue harvesting
Hyaluronic acid
Saline solution (placebo)
Sponsored by
Malmö University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Wound Healing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Odontology, Malmo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hyaluronic acid

Saline solution

Arm Description

Application 3-times per day for 7 days.

Application 3-times per day for 7 days.

Outcomes

Primary Outcome Measures

pain / discomfort (burning) perception by means of a 100 mm VAS
0 indicates no pain, 100 indicates maximum pain
pain / discomfort (burning) perception by means of a 100 mm VAS
0 indicates no pain, 100 indicates maximum pain
pain / discomfort (burning) perception by means of a 100 mm VAS
0 indicates no pain, 100 indicates maximum pain
pain / discomfort (burning) perception by means of a 100 mm VAS
0 indicates no pain, 100 indicates maximum pain

Secondary Outcome Measures

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

Full Information

First Posted
October 9, 2021
Last Updated
July 2, 2023
Sponsor
Malmö University
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1. Study Identification

Unique Protocol Identification Number
NCT05099718
Brief Title
Effect of Hyaluronic Acid on Oral Mucosal Wound Healing - Focus on Pain and Re-epithelisation
Official Title
Effect of Hyaluronic Acid on Oral Mucosal Wound Healing - Focus on Pain and Re-epithelisation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Malmö University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Wound Healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic acid
Arm Type
Experimental
Arm Description
Application 3-times per day for 7 days.
Arm Title
Saline solution
Arm Type
Placebo Comparator
Arm Description
Application 3-times per day for 7 days.
Intervention Type
Procedure
Intervention Name(s)
palatal soft tissue harvesting
Intervention Description
A 6x2mm palatal soft tissue graft will be harvested.
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid
Intervention Description
application 3-times per day for 7 days
Intervention Type
Other
Intervention Name(s)
Saline solution (placebo)
Intervention Description
application 3-times per day for 7 days
Primary Outcome Measure Information:
Title
pain / discomfort (burning) perception by means of a 100 mm VAS
Description
0 indicates no pain, 100 indicates maximum pain
Time Frame
3 days
Title
pain / discomfort (burning) perception by means of a 100 mm VAS
Description
0 indicates no pain, 100 indicates maximum pain
Time Frame
7 days
Title
pain / discomfort (burning) perception by means of a 100 mm VAS
Description
0 indicates no pain, 100 indicates maximum pain
Time Frame
14 days
Title
pain / discomfort (burning) perception by means of a 100 mm VAS
Description
0 indicates no pain, 100 indicates maximum pain
Time Frame
21 days
Secondary Outcome Measure Information:
Title
pain killer consumption
Description
amount of pills taken
Time Frame
3 days
Title
pain killer consumption
Description
amount of pills taken
Time Frame
7 days
Title
pain killer consumption
Description
amount of pills taken
Time Frame
14 days
Title
pain killer consumption
Description
amount of pills taken
Time Frame
21 days
Title
disturbance while eating or drinking by means of a 100 mm VAS
Description
0 indicates no disturbance, 100 indicates maximum disturbance
Time Frame
3 days
Title
disturbance while eating or drinking by means of a 100 mm VAS
Description
0 indicates no disturbance, 100 indicates maximum disturbance
Time Frame
7 days
Title
disturbance while eating or drinking by means of a 100 mm VAS
Description
0 indicates no disturbance, 100 indicates maximum disturbance
Time Frame
14 days
Title
disturbance while eating or drinking by means of a 100 mm VAS
Description
0 indicates no disturbance, 100 indicates maximum disturbance
Time Frame
21 days
Title
taste alteration experience by means of a 100 mm VAS
Description
0 indicates no alteration, 100 indicates maximum alteration
Time Frame
3 days
Title
taste alteration experience by means of a 100 mm VAS
Description
0 indicates no alteration, 100 indicates maximum alteration
Time Frame
7 days
Title
taste alteration experience by means of a 100 mm VAS
Description
0 indicates no alteration, 100 indicates maximum alteration
Time Frame
14 days
Title
taste alteration experience by means of a 100 mm VAS
Description
0 indicates no alteration, 100 indicates maximum alteration
Time Frame
21 days
Title
frequency of re-bleeding
Description
number of events
Time Frame
3 days
Title
frequency of re-bleeding
Description
number of events
Time Frame
7 days
Title
frequency of re-bleeding
Description
number of events
Time Frame
14 days
Title
frequency of re-bleeding
Description
number of events
Time Frame
21 days
Title
re-epithelialised defect area (by means of standardized photographs)
Description
mm2
Time Frame
3 days
Title
re-epithelialised defect area (by means of standardized photographs)
Description
mm2
Time Frame
7 days
Title
re-epithelialised defect area (by means of standardized photographs)
Description
mm2
Time Frame
14 days
Title
re-epithelialised defect area (by means of standardized photographs)
Description
mm2
Time Frame
21 days
Title
re-epithelisation by colorimetric digital assessment of the calibrated photographs
Description
colorimetric assessment
Time Frame
3 days
Title
re-epithelisation by colorimetric digital assessment of the calibrated photographs
Description
colorimetric assessment
Time Frame
7 days
Title
re-epithelisation by colorimetric digital assessment of the calibrated photographs
Description
colorimetric assessment
Time Frame
14 days
Title
re-epithelisation by colorimetric digital assessment of the calibrated photographs
Description
colorimetric assessment
Time Frame
21 days
Title
changes in total and specific bacterial counts
Description
log values
Time Frame
3 days
Title
changes in total and specific bacterial counts
Description
log values
Time Frame
7 days
Title
changes in total and specific bacterial counts
Description
log values
Time Frame
14 days
Title
defect volume fill by overlay of the intraoral scans
Description
mm3
Time Frame
3 days
Title
defect volume fill by overlay of the intraoral scans
Description
mm3
Time Frame
7 days
Title
defect volume fill by overlay of the intraoral scans
Description
mm3
Time Frame
14 days
Title
defect volume fill by overlay of the intraoral scans
Description
mm3
Time Frame
21 days
Title
food restrictions (yes/no)
Time Frame
3 days
Title
food restrictions (yes/no)
Time Frame
7 days
Title
food restrictions (yes/no)
Time Frame
14 days
Title
food restrictions (yes/no)
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Odontology, Malmo University
City
Malmo
Country
Sweden

12. IPD Sharing Statement

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

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