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Completed

NCT Number: NCT06821425

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

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.

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Key information

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Dentistry, Ain Shams University

Cairo, 11511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Xenograft

Other

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

Primary outcomes

  1. - Radiographic evaluation of the changes in the intrabony defect

    Time frame: 6 months

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

Secondary outcomes

  1. Clinical evaluation of the changes in periodontal parameters

    Time frame: 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

  2. Evaluation of surgical wound healing

    Time frame: 1 and 2 weeks after surgery.

    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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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