Faculty of Odontology, Malmo University
Malmö, Sweden
NCT Number: NCT05099718
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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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Malmö, Sweden
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 3 days
0 indicates no pain, 100 indicates maximum pain
Time frame: 7 days
0 indicates no pain, 100 indicates maximum pain
Time frame: 14 days
0 indicates no pain, 100 indicates maximum pain
Time frame: 21 days
0 indicates no pain, 100 indicates maximum pain
Time frame: 3 days
amount of pills taken
Time frame: 7 days
amount of pills taken
Time frame: 14 days
amount of pills taken
Time frame: 21 days
amount of pills taken
Time frame: 3 days
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Time frame: 7 days
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Time frame: 14 days
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Time frame: 21 days
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Time frame: 3 days
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Time frame: 7 days
0 indicates no alteration, 100 indicates maximum alteration
Time frame: 14 days
0 indicates no alteration, 100 indicates maximum alteration
Time frame: 21 days
0 indicates no alteration, 100 indicates maximum alteration
Time frame: 3 days
number of events
Time frame: 7 days
number of events
Time frame: 14 days
number of events
Time frame: 21 days
number of events
Time frame: 3 days
mm2
Time frame: 7 days
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Time frame: 14 days
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Time frame: 21 days
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Time frame: 3 days
colorimetric assessment
Time frame: 7 days
colorimetric assessment
Time frame: 14 days
colorimetric assessment
Time frame: 21 days
colorimetric assessment
Time frame: 3 days
log values
Time frame: 7 days
log values
Time frame: 14 days
log values
Time frame: 3 days
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Time frame: 7 days
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Time frame: 14 days
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Time frame: 21 days
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Time frame: 3 days
Time frame: 7 days
Time frame: 14 days
Time frame: 21 days
Malmö University
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