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

NCT06821425 | Completed Phase 4 DMC

• 1 other identifier: FDASU-RecIM122330
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Disease, AVDC Stage 3

Keywords

Stage III periodontitis; Melatonin gel; Xenograft

Outcome Measures

Primary Outcomes (1)

• - 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 Outcomes (2)

• Clinical evaluation of the changes in periodontal parameters

  Baseline and 6 months

• Evaluation of surgical wound healing

  1 and 2 weeks after surgery.

Study Arms (2)

Melatonin gel with Xenograft group

EXPERIMENTAL

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

Xenograft Only group

ACTIVE COMPARATOR

Ten patients with stage III periodontitis with vertical bone defects will be subjected to application of particulate xenograft alone.

Other: Xenograft

Interventions

Melatonin gel mixed with xenograft DRUG

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.

Melatonin gel with Xenograft group

Xenograft OTHER

Application of Xenograft alone for the surgical management of intrabony periodontal defects.

Xenograft Only group

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders within age range of 35-55 years.
• 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.
• Patients with three-wall intrabony defects.
• Systemically free patients as evidenced by Burket's oral health history questionnaire (Glick et al., 2008)
• Ability to attend the treatment sessions and comply with the procedures, recall visits and oral hygiene measures.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, 11511, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Interventions

Transplantation, Heterologous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: February 12, 2025
• Study Start: January 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-01

Locations

EG (1)