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Completed

NCT Number: NCT05099718

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Odontology, Malmo University

Malmö, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

palatal soft tissue harvesting

Procedure

A 6x2mm palatal soft tissue graft will be harvested.

Hyaluronic Acid

Device

application 3-times per day for 7 days

Saline solution (placebo)

Other

application 3-times per day for 7 days

Primary outcomes

  1. pain / discomfort (burning) perception by means of a 100 mm VAS

    Time frame: 3 days

    0 indicates no pain, 100 indicates maximum pain

  2. pain / discomfort (burning) perception by means of a 100 mm VAS

    Time frame: 7 days

    0 indicates no pain, 100 indicates maximum pain

  3. pain / discomfort (burning) perception by means of a 100 mm VAS

    Time frame: 14 days

    0 indicates no pain, 100 indicates maximum pain

  4. pain / discomfort (burning) perception by means of a 100 mm VAS

    Time frame: 21 days

    0 indicates no pain, 100 indicates maximum pain

Secondary outcomes

  1. pain killer consumption

    Time frame: 3 days

    amount of pills taken

  2. pain killer consumption

    Time frame: 7 days

    amount of pills taken

  3. pain killer consumption

    Time frame: 14 days

    amount of pills taken

  4. pain killer consumption

    Time frame: 21 days

    amount of pills taken

  5. disturbance while eating or drinking by means of a 100 mm VAS

    Time frame: 3 days

    0 indicates no disturbance, 100 indicates maximum disturbance

  6. 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. disturbance while eating or drinking by means of a 100 mm VAS

    Time frame: 14 days

    0 indicates no disturbance, 100 indicates maximum disturbance

  8. disturbance while eating or drinking by means of a 100 mm VAS

    Time frame: 21 days

    0 indicates no disturbance, 100 indicates maximum disturbance

  9. taste alteration experience by means of a 100 mm VAS

    Time frame: 3 days

    0 indicates no alteration, 100 indicates maximum alteration

  10. taste alteration experience by means of a 100 mm VAS

    Time frame: 7 days

    0 indicates no alteration, 100 indicates maximum alteration

  11. taste alteration experience by means of a 100 mm VAS

    Time frame: 14 days

    0 indicates no alteration, 100 indicates maximum alteration

  12. taste alteration experience by means of a 100 mm VAS

    Time frame: 21 days

    0 indicates no alteration, 100 indicates maximum alteration

  13. frequency of re-bleeding

    Time frame: 3 days

    number of events

  14. frequency of re-bleeding

    Time frame: 7 days

    number of events

  15. frequency of re-bleeding

    Time frame: 14 days

    number of events

  16. frequency of re-bleeding

    Time frame: 21 days

    number of events

  17. re-epithelialised defect area (by means of standardized photographs)

    Time frame: 3 days

    mm2

  18. re-epithelialised defect area (by means of standardized photographs)

    Time frame: 7 days

    mm2

  19. re-epithelialised defect area (by means of standardized photographs)

    Time frame: 14 days

    mm2

  20. re-epithelialised defect area (by means of standardized photographs)

    Time frame: 21 days

    mm2

  21. re-epithelisation by colorimetric digital assessment of the calibrated photographs

    Time frame: 3 days

    colorimetric assessment

  22. re-epithelisation by colorimetric digital assessment of the calibrated photographs

    Time frame: 7 days

    colorimetric assessment

  23. re-epithelisation by colorimetric digital assessment of the calibrated photographs

    Time frame: 14 days

    colorimetric assessment

  24. re-epithelisation by colorimetric digital assessment of the calibrated photographs

    Time frame: 21 days

    colorimetric assessment

  25. changes in total and specific bacterial counts

    Time frame: 3 days

    log values

  26. changes in total and specific bacterial counts

    Time frame: 7 days

    log values

  27. changes in total and specific bacterial counts

    Time frame: 14 days

    log values

  28. defect volume fill by overlay of the intraoral scans

    Time frame: 3 days

    mm3

  29. defect volume fill by overlay of the intraoral scans

    Time frame: 7 days

    mm3

  30. defect volume fill by overlay of the intraoral scans

    Time frame: 14 days

    mm3

  31. defect volume fill by overlay of the intraoral scans

    Time frame: 21 days

    mm3

  32. food restrictions (yes/no)

    Time frame: 3 days

  33. food restrictions (yes/no)

    Time frame: 7 days

  34. food restrictions (yes/no)

    Time frame: 14 days

  35. food restrictions (yes/no)

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Malmö University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 29, 2021
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.