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

NCT05122130 | Unknown Phase 2

• 1 other identifier: 0252-06/2021
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Heal

Keywords

Gelatin sponge; melatonin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Intensity of pain

  Up 2 weeks

Study Arms (2)

Melatonin group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

•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

Interventions

Melatonin DRUG

The donor site will be dressed with melatonin loaded gelatin sponge

Also known as: N-ACETYL-5-METHOXY TRYPTAMINE

Melatonin group

Carbopol DRUG

The donor site will be dressed with carbopol loaded gelatin sponge (placebo).

Placebo group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Patients who have at least 4 mm thickness of palatal mucosa (at donor site)

You may not qualify if:

• History of smoking.
• Patients who have any known disease that interfere with periodontal surgery.
• Patients who have any dermal or autoimmune diseases.
• Patients who have any previous adverse reactions to the products (or similar products) used in this study.
• Pregnant and lactating women.
• Patients who have a palatal infection.

Sponsors & Collaborators

• Salma Nabil: lead

Study Sites (1)

Alexandria University

Alexandria, Egypt

RECRUITING

MeSH Terms

Interventions

Melatonin; carboxypolymethylene

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• salma Nabil, BDS

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salma Nabil, BDS

CONTACT

01099076119; Salma.Nabil.dent@alexu.edu.eg

Ahmed haggag, BDS

CONTACT

01066292227; ahmedhagag90@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 16, 2021
• Study Start: November 20, 2021
• Primary Completion: September 20, 2022
• Study Completion: December 20, 2022
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

EG (1)