Efficacy of Collagen Sponge on Palatal Wound Healing

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The included patients will be randomized into two groups. The patients in control group will be treated with gelatin sponge and those in the test group will be treated with collagen sponge. The postoperative pain will be assessed by VAS scale at day 1, 3 and 7 after surgery. Epithelialization of the palatal wound will be evaluated by hydrogen peroxide test and digital photography at 1 week postoperatively. Additionally, postoperative pain, consumption of analgesics, willingness to repeat the treatment and the existence of delayed bleeding will be recorded at 1 week. At 2 weeks, 3 weeks and 1 month after surgery, epithelialization of the palatal wound and aesthetic scores will be evaluated.

Official Title
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Efficacy of Collagen Sponge on Palatal Wound Healing: a Randomized Controlled Clinical Trial

Conditions
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Gingival Recession, Inadequately Attached Gingiva

Intervention / Treatment
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* Procedure: Palatal soft tissue graft harvesting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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% Exclusion Criteria: Smoking Pregnancy or lactation Untreated periodontal disease Severe systemic conditions that contraindicate surgery (diabetes, heart disease, cancer etc.) Presence of coagulation disorders (history of Haemophilia, von Wille-brand disease, or anticoagulant therapy) Taking medications affecting periodontal health or healing Previous surgery for a palate graft harvested from the experimental sites

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gelatin Sponge<br>The palatal wound will be protected with an absorbable gelatin sponge, which will be stabilized by non-resorbable sling sutures. | Procedure: Palatal soft tissue graft harvesting<br>* After 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.<br>|
| Experimental: Collagen Sponge<br>The palatal wound will be protected with a collagen sponge, which will be stabilized by non-resorbable sling sutures. | Procedure: Palatal soft tissue graft harvesting<br>* After 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | at 1 week | 
| 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). | at 2 weeks | 
| 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). | at 3 weeks | 
| 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). | at 1 month | 
| epithelialization of the palatal wound evaluated by digital photography | The epithelialization of the palatal wound will be recorded as yes or no according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline. | at 1 week | 
| epithelialization of the palatal wound evaluated by digital photography | The epithelialization of the palatal wound will be recorded as yes or no according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline. | at 2 weeks | 
| epithelialization of the palatal wound evaluated by digital photography | The epithelialization of the palatal wound will be recorded as yes or no according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline. | at 3 weeks | 
| epithelialization of the palatal wound evaluated by digital photography | The epithelialization of the palatal wound will be recorded as yes or no according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline. | at 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable) | at day 1 | 
| postoperative pain | using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable) | at day 3 | 
| postoperative pain | using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable) | at day 7 | 
| consumption of analgesics | to answer the following question: Did you take any analgesics due to the palatal pain since the procedure was completed? | at 1 week | 
| willingness to repeat the treatment | using a VAS ranging from 0 to 10 (0 = strong unwilling and 10 = strong willing) | at 1 week | 
| the existence of delayed bleeding | the occurrence of prolonged hemorrhaging during the first week | at 1 week | 
| aesthetic score | assessed by judging on the color, contour, and texture of the donor sites. The total score will vary between 0 and 6 by scoring each subject from 0 to 2 (0=inharmonious with adjacent tissue, 1=moderately harmonious with adjacent tissue and 2=very harmonious with adjacent tissue). | at 3 weeks | 
| aesthetic score | assessed by judging on the color, contour, and texture of the donor sites. The total score will vary between 0 and 6 by scoring each subject from 0 to 2 (0=inharmonious with adjacent tissue, 1=moderately harmonious with adjacent tissue and 2=very harmonious with adjacent tissue). | at 1 month |