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

Ain Shams University

Status and phase: Not yet enrolling; Phase 4

Conditions: Periodontal Disease, AVDC Stage 3

Treatments: Other: Xenograft; Drug: Melatonin gel mixed with xenograft

Study type: Interventional

Funder types: Other

Identifiers

NCT06821425

FDASU-RecIM122330

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 35 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Melatonin gel with Xenograft group

Experimental group

Description:

Ten patients with stage III periodontitis with vertical bone defects will be subjected to application of particulate xenograft mixed with 5% melatonin gel.

Treatment:

Drug: Melatonin gel mixed with xenograft

Xenograft Only group

Active Comparator group

Description:

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

Treatment:

Other: Xenograft