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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
A 6x2mm palatal soft tissue graft will be harvested.
application 3-times per day for 7 days
application 3-times per day for 7 days
Faculty of Odontology, Malmo University
Malmo, Sweden
pain / discomfort (burning) perception by means of a 100 mm VAS
0 indicates no pain, 100 indicates maximum pain
Time frame: 3 days
pain / discomfort (burning) perception by means of a 100 mm VAS
0 indicates no pain, 100 indicates maximum pain
Time frame: 7 days
pain / discomfort (burning) perception by means of a 100 mm VAS
0 indicates no pain, 100 indicates maximum pain
Time frame: 14 days
pain / discomfort (burning) perception by means of a 100 mm VAS
0 indicates no pain, 100 indicates maximum pain
Time frame: 21 days
pain killer consumption
amount of pills taken
Time frame: 3 days
pain killer consumption
amount of pills taken
Time frame: 7 days
pain killer consumption
amount of pills taken
Time frame: 14 days
pain killer consumption
amount of pills taken
Time frame: 21 days
disturbance while eating or drinking by means of a 100 mm VAS
0 indicates no disturbance, 100 indicates maximum disturbance
Time frame: 3 days
disturbance while eating or drinking by means of a 100 mm VAS
0 indicates no disturbance, 100 indicates maximum disturbance
Time frame: 7 days
disturbance while eating or drinking by means of a 100 mm VAS
0 indicates no disturbance, 100 indicates maximum disturbance
Time frame: 14 days
disturbance while eating or drinking by means of a 100 mm VAS
0 indicates no disturbance, 100 indicates maximum disturbance
Time frame: 21 days
taste alteration experience by means of a 100 mm VAS
0 indicates no alteration, 100 indicates maximum alteration
Time frame: 3 days
taste alteration experience by means of a 100 mm VAS
0 indicates no alteration, 100 indicates maximum alteration
Time frame: 7 days
taste alteration experience by means of a 100 mm VAS
0 indicates no alteration, 100 indicates maximum alteration
Time frame: 14 days
taste alteration experience by means of a 100 mm VAS
0 indicates no alteration, 100 indicates maximum alteration
Time frame: 21 days
frequency of re-bleeding
number of events
Time frame: 3 days
frequency of re-bleeding
number of events
Time frame: 7 days
frequency of re-bleeding
number of events
Time frame: 14 days
frequency of re-bleeding
number of events
Time frame: 21 days
re-epithelialised defect area (by means of standardized photographs)
mm2
Time frame: 3 days
re-epithelialised defect area (by means of standardized photographs)
mm2
Time frame: 7 days
re-epithelialised defect area (by means of standardized photographs)
mm2
Time frame: 14 days
re-epithelialised defect area (by means of standardized photographs)
mm2
Time frame: 21 days
re-epithelisation by colorimetric digital assessment of the calibrated photographs
colorimetric assessment
Time frame: 3 days
re-epithelisation by colorimetric digital assessment of the calibrated photographs
colorimetric assessment
Time frame: 7 days
re-epithelisation by colorimetric digital assessment of the calibrated photographs
colorimetric assessment
Time frame: 14 days
re-epithelisation by colorimetric digital assessment of the calibrated photographs
colorimetric assessment
Time frame: 21 days
changes in total and specific bacterial counts
log values
Time frame: 3 days
changes in total and specific bacterial counts
log values
Time frame: 7 days
changes in total and specific bacterial counts
log values
Time frame: 14 days
defect volume fill by overlay of the intraoral scans
mm3
Time frame: 3 days
defect volume fill by overlay of the intraoral scans
mm3
Time frame: 7 days
defect volume fill by overlay of the intraoral scans
mm3
Time frame: 14 days
defect volume fill by overlay of the intraoral scans
mm3
Time frame: 21 days
food restrictions (yes/no)
Time frame: 3 days
food restrictions (yes/no)
Time frame: 7 days
food restrictions (yes/no)
Time frame: 14 days
food restrictions (yes/no)
Time frame: 21 days
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