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

Sponsor
Salma Nabil (Other)
Overall Status
Recruiting
CT.gov ID
NCT05122130
Collaborator
(none)
26
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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.
Primary Purpose:
Treatment
Official Title:
Effect of Topically Applied Melatonin (N-ACETYL-5-METHOXY TRYPTAMINE) Loaded Gelatin Sponge on Palatal Wound Healing (Randomized Controlled Clinical Trial)
Actual Study Start Date :
Nov 20, 2021
Anticipated Primary Completion Date :
Sep 20, 2022
Anticipated Study Completion Date :
Dec 20, 2022

Arms and Interventions

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).

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alexandria University Alexandria Egypt

    Sponsors and Collaborators

    • Salma Nabil

    Investigators

    • Principal Investigator: salma Nabil, BDS, Alexandria University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Salma Nabil, principle investigator, Alexandria University
    ClinicalTrials.gov Identifier:
    NCT05122130
    Other Study ID Numbers:
    • 0252-06/2021
    First Posted:
    Nov 16, 2021
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Salma Nabil, principle investigator, Alexandria University
    Gelatin sponge
    melatonin
    Additional relevant MeSH terms:
    Wounds and Injuries
    Melatonin

    Study Results

    No Results Posted as of Jan 26, 2022