Efficacy of Collagen Sponge on Palatal Wound Healing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe Dental Hospital of Zhejiang University School of Medicine
About this trial
The aim of this study is to compare the efficacy of collagen sponge and gelatin sponge on the palatal wound healing and postoperative pain following gingival graft harvesting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Clinical indications utilizing free gingival grafts or de-epithelialized gingival grafts to treat either insufficient keratinized tissue or gingival recession defects
Full-mouth plaque score and full-mouth bleeding score lower than 20%
Disqualifiers
Smoking
Pregnancy or lactation
Untreated periodontal disease
Severe systemic conditions that contraindicate surgery (diabetes, heart disease, cancer etc.)
Trial design
Design model
Parallel
Treatments tested in this trial
Palatal soft tissue graft harvesting
Procedure/SurgeryAfter local anaesthesia, a horizontal incision 2 mm apically from the gingival margin will be carried out using a #15C blade. The standardized rectangular graft with a thickness of 1.5 mm will be harvested from distal aspect of canine till first molar. The graft will be lifted and separated using tissue forceps and a blade till it is free from all sides.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Gelatin SpongeActive comparator 1 intervention
Group B: Collagen SpongeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
epithelialization of the palatal wound evaluated by hydrogen peroxide test
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
Time frame
at 1 week2
epithelialization of the palatal wound evaluated by hydrogen peroxide test
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
Time frame
at 2 weeks3
epithelialization of the palatal wound evaluated by hydrogen peroxide test
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
Time frame
at 3 weeks4
epithelialization of the palatal wound evaluated by hydrogen peroxide test
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
Time frame
at 1 monthSecondary outcomes
1
postoperative pain
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
Time frame
at day 12
postoperative pain
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
Time frame
at day 33
postoperative pain
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
Time frame
at day 74
consumption of analgesics
to answer the following question: Did you take any analgesics due to the palatal pain since the procedure was completed?
Time frame
at 1 weekSponsors and contacts
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Source ClinicalTrials.gov