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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Heal
• Intervention / Treatment: Drug: Melatonin; Drug: Carbopol

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 Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Salma Nabil, BDS; Phone Number: 002 01099076119; Email: Salma.Nabil.dent@alexu.edu.eg
• Study Contact Backup: Name: Ahmed haggag, BDS; Phone Number: 002 01066292227; Email: ahmedhagag90@gmail.com

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria University
    • Contact: Phone Number: 4869690
    • Sub-Investigator: Salma Nabil, BDS
    • Principal Investigator: Gehan Kotry, PhD
    • Principal Investigator: yasmine Gaweesh, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Melatonin group; 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.	Drug: Melatonin; The donor site will be dressed with melatonin loaded gelatin sponge; Other Names: N-ACETYL-5-METHOXY TRYPTAMINE
Placebo Comparator: Placebo group; •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	Drug: Carbopol; The donor site will be dressed with carbopol loaded gelatin sponge (placebo).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Salma Nabil
• Investigators: Principal Investigator: salma Nabil, BDS, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2021
• Primary Completion (Anticipated): September 20, 2022
• Study Completion (Anticipated): December 20, 2022

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: melatonin; Gelatin sponge
• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: 0252-06/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No