Back to results

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

Primary Purpose

Wound Heal

Status

Recruiting

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Melatonin

Carbopol

About this trial

This is an interventional treatment trial for Wound Heal focused on measuring Gelatin sponge, melatonin

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

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)

Exclusion Criteria:

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.

Sites / Locations

Alexandria UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin group

Placebo group

Arm Description

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.

•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

Outcomes

Primary Outcome Measures

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])

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT05122130

First Posted

November 5, 2021

Last Updated

January 11, 2022

Sponsor

Salma Nabil

1. Study Identification

Unique Protocol Identification Number

NCT05122130

Brief Title

Effect of Melatonin on Palatal Wound Healing (Randomized Controlled 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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 20, 2021 (Actual)

Primary Completion Date

September 20, 2022 (Anticipated)

Study Completion Date

December 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Salma Nabil

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wound Heal

Keywords

Gelatin sponge, melatonin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes 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.

Allocation

Randomized

Enrollment

26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Melatonin group

Arm Type

Experimental

Arm Description

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Melatonin

Other Intervention Name(s)

N-ACETYL-5-METHOXY TRYPTAMINE

Intervention Description

The donor site will be dressed with melatonin loaded gelatin sponge

Intervention Type

Drug

Intervention Name(s)

Carbopol

Intervention Description

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

Primary Outcome Measure Information:

Title

palatal wound healing

Description

Time Frame

Up to 2 weeks

Secondary Outcome Measure Information:

Title

Intensity of pain

Description

by visual analogue scale Patients will be asked to grade the severity of their symptoms on VAS that ranges from (0-100 mm)

Time Frame

Up 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria 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) Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Salma Nabil, BDS

Phone

01099076119

Ext

002

Salma.Nabil.dent@alexu.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed haggag, BDS

Phone

01066292227

Ext

002

ahmedhagag90@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

salma Nabil, BDS

Organizational Affiliation

Alexandria University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alexandria University

City

Alexandria

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

Phone

4869690

First Name & Middle Initial & Last Name & Degree

Salma Nabil, BDS

First Name & Middle Initial & Last Name & Degree

Gehan Kotry, PhD

First Name & Middle Initial & Last Name & Degree

yasmine Gaweesh, PhD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs