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

Ain Shams University20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Periodontal Disease, AVDC Stage 3

Melatonin gel mixed with xenograftDRUG

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.

XenograftOTHER

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

Eligibility

Sex: ALLMin age: 35 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

- Radiographic evaluation of the changes in the intrabony defect

The amount of bone gain in millimeters in follow up radiograph compared to preoperative radiograph

Time frame: 6 months

Secondary Outcomes

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

Time frame: 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.

Time frame: 1 and 2 weeks after surgery.