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IRCT20251201068171N1 IRCT 2026-01-30 Tabriz University of Medical Sciences The effect of topical melatonin combined with xenogeneic bone graft powder on bone formation and the width of keratinized gingiva in the extraction site. The effect of using melatonin hormone locally along with xenograft on bone regeneration and improving the quality of soft tissue in the extracted tooth area 2026-01-20 anticipated 20 Complete https://irct.ir/trial/87850 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Randomization method: In this split-mouth study, each patient served as their own control. Sites within the mouth (e.g., right or left side) were randomly assigned to the intervention or control. Random allocation was performed using a random number table to minimize bias, Blinding description: 1 Patient Blinding • Patients were unaware of which side of the mouth was assigned to the intervention group (melatonin + xenograft) and which side was assigned to the control group (xenograft only) 2 Surgeon and Evaluator Blinding • The surgeon was unaware of the allocation during the intervention and tissue sampling • Clinical and histological evaluators were also blinded to the allocation of each site 3 Allocation Control • Group allocation was performed by an independent person and the information was kept in sealed envelopes • The envelopes were opened only at the time of the intervention by the responsible operator. N/A Dental socket preservation. Intervention 1: Intervention group: In the intervention group, following tooth extraction, the extraction socket is filled with xenograft bone powder combined with melatonin.This study is designed as a split-mouth trial, in which one side of each patient’s mouth is randomly assigned to receive the intervention (xenograft with melatonin), while the contralateral side serves as the control group and receives xenograft bone powder alone without melatonin. Intervention 2: Control group: In the control group, following tooth extraction, the extraction socket is filled with xenograft bone powder without melatonin. Yes - There is a plan to make this available What will be shared: The data will be published as part of a peer-reviewed article When: Access to the data will be available after final publication of the article. To whom: The data may be accessible by the general public Conditions: provided that proper citation to the published article is made. Where to obtain: Requests for access to the data should be directed to the corresponding author via email. How to obtain: Correspondence via email with the corresponding author. Comments:
public Mahdi Nozhati Maleki
Golestan Boys' Dormitory, Sari Zamin, First Uphill of Mirdamad, University Square, Tabriz, East Azerbaijan
Tabriz Iran (Islamic Republic of) 5165995131 +98 41 3784 2502 Mahdinozhati2002@gmail.com Tabriz University of Medical Sciences scientific Farzain Ahmadpour pournak
Golestan Boys' Dormitory, Sari Zamin, First Uphill of Mirdamad, University Square, Tabriz, East Azerbaijan
Tabriz Iran (Islamic Republic of) 5165995131 +98 41 3784 2502 phoenixinfire@ymail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with non-restorable teeth who are candidates for implant treatment 18 years 50 years Both Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, following tooth extraction, the extraction socket is filled with xenograft bone powder combined with melatonin.This study is designed as a split-mouth trial, in which one side of each patient’s mouth is randomly assigned to receive the intervention (xenograft with melatonin), while the contralateral side serves as the control group and receives xenograft bone powder alone without melatonin. Control group: In the control group, following tooth extraction, the extraction socket is filled with xenograft bone powder without melatonin. Primary Outcome Variable Description:The primary outcome variable is the amount of newly formed bone in the dental socket after using melatonin combined with xenograft compared to xenograft alone. Timepoint: Time Points of Measurement: 1. Baseline (before tooth extraction / intervention): Measurement of attached gingiva thickness as a reference for soft tissue evaluation 2. Immediately after material placement in the dental socket: Initial clinical observations recorded 3. Week 1 and Week 2 post-surgery: Clinical follow-up including suture closure, swelling, infection, and unpleasant odor 4. Two months post-surgery: • Bone sampling from both intervention and control sites before implant placement • Radiographic assessment to evaluate bone status and structural changes. Method of measurement: The bone formation is measured using histological analysis (histomorphometry) or image analysis software (Image-Pro Plus) • Results are reported as the percentage of new bone relative to the total tissue section area. The secondary outcome variable is attached gingiva thickness around the dental socket, reflecting soft tissue changes after using melatonin combined with xenograft compared to xenograft alone. Timepoint: 1. Baseline (before tooth extraction / intervention): Measurement of attached gingiva thickness using a periodontal probe 2. Immediately after material placement in the dental socket: Recording initial clinical observations of the gingiva 3. Week 1 and Week 2 post-surgery: Clinical assessment of the gingiva, including swelling, inflammation, and soft tissue healing 4. Two months post-surgery: Re-measurement of attached gingiva thickness to evaluate soft tissue changes. Method of measurement: Measurements are performed using a periodontal probe and recorded at predefined time points. Tabriz University of Medical Sciences Approved 2025-11-22 Ethics committee of Tabriz University of Medical Sciences Golestan Boys' Dormitory, Sari Zamin, First Uphill of Mirdamad, University Square, Tabriz, East Azerbaijan Tabriz East Azarbaijan Iran (Islamic Republic of)