Effect of Melatonin on Palatal Wound Healing (Randomized Controlled Clinical Trial)

Phase 2

• Conditions: Wound Heal
• Interventions: Drug: Melatonin; Drug: Carbopol

• Registration Number: NCT05122130
• Lead Sponsor: Salma Nabil

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.

Study Timeline

• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-16
• Study Start: 2021-11-20
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-26
• Primary Completion: 2022-09-20
• Study Completion: 2022-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin group	Melatonin	Melatonin loaded Carbopol hydrogel will be synthesized as follows: 1 gm of Carbopol will be dissolved in 100 ml deionized water while stirring at 600 rpm for 25°C. Melatonin (3gm) will be dissolved in 1 ml ethanol and added to the formed gel while stirring at 600 rpm at 25 °C. The pH will be adjusted to 7.4 using triethanolamine until a gel is formed and it will be loaded on gelatin sponge and will be applied to the donor site.
Placebo group	Carbopol	•Topical placebo carbopol gel will be prepared as follows: 1 gm of Carbopol will be dissolved in 100ml deionized water while stirring at 600 rpm for 25°C. The pH will be adjusted to 7.4 using triethanolamine until a gel is formed

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt