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

Wound Heal Clinical Trial

Official title:

Effect of Topically Applied Melatonin (N-ACETYL-5-METHOXY TRYPTAMINE) Loaded Gelatin Sponge on Palatal Wound Healing (Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05122130
• Other study ID #: 0252-06/2021
• Status: Recruiting
• Phase: Phase 2
• Start date: November 20, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: January 2022
• Source: Alexandria University
• Contact: Salma Nabil, BDS
• Phone: 01099076119
• Email: Salma.Nabil.dent[@]alexu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: December 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wound Heal
• Wounds and Injuries

Intervention

Drug:
• Melatonin
The donor site will be dressed with melatonin loaded gelatin sponge
• Carbopol
The donor site will be dressed with carbopol loaded gelatin sponge (placebo).

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Salma Nabil

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	palatal wound healing	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])	Up to 2 weeks
Secondary	Intensity of pain	by visual analogue scale Patients will be asked to grade the severity of their symptoms on VAS that ranges from (0-100 mm)	Up 2 weeks