Clinical trial NCT06821425: Melatonin Gel As an Adjuvant in the Surgical Management of Intrabony Defects
Official title: Melatonin Gel As an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects (A Randomized Controlled Clinical Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Periodontal Disease, AVDC Stage 3
Keywords: Stage III periodontitis
Melatonin gel
Xenograft
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: - Radiographic evaluation of the changes in the intrabony defect
timeFrame: 6 months
Secondary outcomes:
measure: Clinical evaluation of the changes in periodontal parameters
timeFrame: Baseline and 6 months
measure: Evaluation of surgical wound healing
timeFrame: 1 and 2 weeks after surgery.
Other outcomes:
Locations:
Study officials:
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