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

Not Applicable

Completed

• Conditions: Soft Tissue Wound Healing

• Registration Number: NCT05099718
• Lead Sponsor: Malmö University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-09
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-10-29
• Study Start: 2022-01-10
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-02
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
pain / discomfort (burning) perception by means of a 100 mm VAS	21 days	0 indicates no pain, 100 indicates maximum pain

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Odontology, Malmo University; 🇸🇪 Malmo, Sweden