Effect of Hyaluronic Acid on Oral Mucosal Wound Healing - Focus on Pain and Re-epithelisation
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2021
CompletedFirst Posted
Study publicly available on registry
October 29, 2021
CompletedStudy Start
First participant enrolled
January 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedJuly 5, 2023
July 1, 2023
1.4 years
October 9, 2021
July 2, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
pain / discomfort (burning) perception by means of a 100 mm VAS
0 indicates no pain, 100 indicates maximum pain
3 days
pain / discomfort (burning) perception by means of a 100 mm VAS
0 indicates no pain, 100 indicates maximum pain
7 days
pain / discomfort (burning) perception by means of a 100 mm VAS
0 indicates no pain, 100 indicates maximum pain
14 days
pain / discomfort (burning) perception by means of a 100 mm VAS
0 indicates no pain, 100 indicates maximum pain
21 days
Secondary Outcomes (35)
pain killer consumption
3 days
pain killer consumption
7 days
pain killer consumption
14 days
pain killer consumption
21 days
disturbance while eating or drinking by means of a 100 mm VAS
3 days
- +30 more secondary outcomes
Study Arms (2)
Hyaluronic acid
EXPERIMENTALApplication 3-times per day for 7 days.
Saline solution
PLACEBO COMPARATORApplication 3-times per day for 7 days.
Interventions
A 6x2mm palatal soft tissue graft will be harvested.
Eligibility Criteria
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Malmö Universitylead
Study Sites (1)
Faculty of Odontology, Malmo University
Malmo, Sweden
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
October 9, 2021
First Posted
October 29, 2021
Study Start
January 10, 2022
Primary Completion
May 31, 2023
Study Completion
May 31, 2023
Last Updated
July 5, 2023
Record last verified: 2023-07