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

Phase 4

Not yet recruiting

• Conditions: Periodontal Disease, AVDC Stage 3
• Interventions: Drug: Melatonin gel mixed with xenograft; Other: Xenograft

• Registration Number: NCT06821425
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-02-09
• Last Update Submitted: 2025-02-09
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Study Start: 2025-02-25
• Primary Completion: 2025-09
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin gel with Xenograft group	Melatonin gel mixed with xenograft	Ten patients with stage III periodontitis with vertical bone defects will be subjected to application of particulate xenograft mixed with 5% melatonin gel.
Xenograft Only group	Xenograft	Ten patients with stage III periodontitis with vertical bone defects will be subjected to application of particulate xenograft alone.

Primary Outcome Measures

Name	Time	Method
- Radiographic evaluation of the changes in the intrabony defect	6 months	The amount of bone gain in millimeters in follow up radiograph compared to preoperative radiograph

Secondary Outcome Measures

Name	Time	Method
Clinical evaluation of the changes in periodontal parameters	Baseline and 6 months	The amount of reduction in Probing pocket depth (PD) in mm The new level of clinical attachment (CAL) in relation the CEJ in mm
Evaluation of surgical wound healing	1 and 2 weeks after surgery.	Landry's Healing Index which measures five clinical outcome parameters: tissue colour, bleeding on palpation, presence of granulation tissue, incision margin (epithelialisation and connective tissue exposure), and suppuration. Scores range from 0 (poor healing) to 5 (excellent healing).