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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-20

Study Completion Date

2022-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Melatonin Gel as an Adjuvant in the Surgical Management of Intrabony Defects

NCT06821425

Periodontal Disease, AVDC Stage 3

COMPLETED PHASE4

Adjunctive Use of an Antibacterial Honey Dressing for Palatal Wound Healing After Harvesting a Free Gingival Graft

NCT04269694

Healing Wound

UNKNOWN PHASE4

Efficacy of Collagen Sponge on Palatal Wound Healing

NCT05287763

Gingival Recession Inadequately Attached Gingiva

RECRUITING NA

Assessment of a Carvacrol-loaded Absorbable Gelatin Sponge Used As a Palatal Dressing Following Free Gingival Graft Harvesting: a Randomized Clinical Study

NCT06806566

Palatal Wound

RECRUITING NA

Clinical Comparison of Application of Curcumin Gel in Pain Management After Free Gingival Graft Harvesting

NCT05819632

Palate; Wound

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wound Heal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

The donor site will be dressed with melatonin loaded gelatin sponge

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

Group Type PLACEBO_COMPARATOR

Carbopol

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Melatonin

The donor site will be dressed with melatonin loaded gelatin sponge

Intervention Type DRUG

Carbopol

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

N-ACETYL-5-METHOXY TRYPTAMINE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No