Wound Heal
Conditions
Keywords
Gelatin sponge, melatonin
Brief summary
The aim of the study is to assess the effect of topical melatonin loaded gelatin sponge on donor palatal site healing, after palatal graft harvesting.
Detailed description
Autogenous soft tissue grafts can be considered the gold standard treatment for many muco-gingival problems. The most common site for harvesting soft tissue grafts is the palate. Many harvesting techniques have emerged, but the epithelialized graft harvesting technique is one of the most reliable and effective techniques as it imparts the superficial section of the connective tissue which contains the highest amount of lamina propria. Unfortunately, it leaves an open palatal wound healed by secondary intention, increasing pain and post-operative morbidity. In order to overcome these inadequacies investigators will cover the donor site with melatonin loaded gelatin sponge and evaluate its effect on the healing process.
Interventions
DRUGMelatonin
The donor site will be dressed with melatonin loaded gelatin sponge
DRUGCarbopol
The donor site will be dressed with carbopol loaded gelatin sponge (placebo).
Sponsors
Salma Nabil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
This study will be double-blinded where the patients and the statistician will be unaware of the treatment assignment till the end of the trial.
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who have at least one site of natural dentition or dental implants that need to be treated by free palatal graft surgery for indications including progressive recession, planned prosthodontics, presence of a mucogingival deformity, or a lack of keratinized gingiva. 2. Patients who have at least 4 mm thickness of palatal mucosa (at donor site)
Exclusion criteria
1. History of smoking. 2. Patients who have any known disease that interfere with periodontal surgery. 3. Patients who have any dermal or autoimmune diseases. 4. Patients who have any previous adverse reactions to the products (or similar products) used in this study. 5. Pregnant and lactating women. 6. Patients who have a palatal infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| palatal wound healing | Up to 2 weeks | Standardized clinical photographs of the palatal surgical sites will be taken and will be imported into a software program (ImageJ 1.49v) and wound areas will be calculated by computerized planimetry (Difference in remaining wound area \[mm2\]) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of pain | Up 2 weeks | by visual analogue scale Patients will be asked to grade the severity of their symptoms on VAS that ranges from (0-100 mm) |
Countries
Egypt
Contacts
Primary ContactSalma Nabil, BDS
Backup ContactAhmed haggag, BDS
Outcome results
None listed