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

Melatonin Gel as an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects (A Randomized Controlled Clinical Study)

Surgical periodontal therapy is a commonly employed treatment approach aimed at arresting disease progression and promoting tissue regeneration. Despite advancements in surgical techniques, adjunctive therapies are being explored to enhance the outcomes of periodontal surgical debridement. Melatonin, a hormone primarily known for its role in regulating the sleep-wake cycle, has emerged as a promising candidate for periodontal therapy. It possesses potent antioxidant, anti-inflammatory, and immunomodulatory properties, which make it an attractive therapeutic agent for treating periodontitis. Additionally, melatonin has been linked to bone metabolism, with evidence suggesting its involvement in bone formation and remodeling processes. Bone regeneration is a vital aspect of periodontal therapy, as the restoration of lost osseous structures is crucial for long-term stability of affected teeth. Previous studies have suggested that melatonin may exert positive effects on bone formation by promoting osteoblast differentiation, stimulating matrix synthesis, and inhibiting osteoclast activity. However, limited research has been conducted to specifically evaluate its influence on bone regeneration in the context of surgical periodontal flap therapy.

Study Overview

• Status: Completed
• Conditions: Periodontal Disease, AVDC Stage 3
• Intervention / Treatment: Drug: Melatonin gel mixed with xenograft; Other: Xenograft

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Faculty of dentistry, Ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Both genders within age range of 35-55 years.

2. Patients diagnosed with periodontitis Stage III (Caton et al., 2018; Papapanou et al., 2018).

   Test site criteria: (probing pocket depth ≥6mm and CAL ≥5mm and 3-wall intrabondy defect). All these criteria will be determined after phase I conventional periodontal therapy.

3. Patients with three-wall intrabony defects.
4. Systemically free patients as evidenced by Burket's oral health history questionnaire (Glick et al., 2008)
5. Ability to attend the treatment sessions and comply with the procedures, recall visits and oral hygiene measures.

Exclusion Criteria:

1. Smokers. (Reynolds et al., 2015)
2. Drug abusers.
3. Pregnant or lactating females.
4. Patients under any medication that affect periodontal healing.
5. Vulnerable individuals.

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 gel with Xenograft group; Ten patients with stage III periodontitis with vertical bone defects will be subjected to application of particulate xenograft mixed with 5% melatonin gel.	Drug: Melatonin gel mixed with xenograft; This study will be conducted to evaluate the effect of melatonin (5% gel) when used as an adjunct to xenograft for the surgical management of intrabony periodontal defects.
Active Comparator: Xenograft Only group; Ten patients with stage III periodontitis with vertical bone defects will be subjected to application of particulate xenograft alone.	Other: Xenograft; Application of Xenograft alone for the surgical management of intrabony periodontal defects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- Radiographic evaluation of the changes in the intrabony defect	The amount of bone gain in millimeters in follow up radiograph compared to preoperative radiograph	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical evaluation of the changes in periodontal parameters	The amount of reduction in Probing pocket depth (PD) in mm The new level of clinical attachment (CAL) in relation the CEJ in mm	Baseline and 6 months
Evaluation of surgical wound healing	Early Healing Index (EHI) to assess the quality of a wound in the days or weeks following a procedure, developed by Wachtel et al. to evaluate flap closure, the presence and amount of fibrin (a blood clot component), and the degree of tissue necrosis. A lower EHI score (such as 1-3) indicates better, complete healing, whereas higher scores (e.g., 4-5) suggest incomplete or poor healing.	1 and 2 weeks after surgery.

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: February 9, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Xenograft; Stage III periodontitis; Melatonin gel
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontitis; Periodontal Diseases; Surgical Procedures, Operative; Transplantation; Transplantation, Heterologous
• Other Study ID Numbers: FDASU-RecIM122330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No