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Completed

NCT Number: NCT07829393

Topical Melatonin for Immediate Implants in Chronically Infected Extraction Sockets

The purpose of this study is to evaluate the effect of topical 2% melatonin gel on implant stability and osseointegration of immediate implants placed in chronically infected extraction sockets. Sixty patients requiring extraction of non-restorable teeth associated with chronic apical lesions will be randomly assigned to receive either conventional immediate implant placement with bone graft only or immediate implant placement with adjunctive topical melatonin. Implant stability will be assessed using resonance frequency analysis over a 12-month follow-up period. Secondary outcomes will include marginal bone loss, peri-implant bone density, postoperative pain, soft tissue healing, postoperative infection, and implant survival.

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Key information

Conditions

Chronic Apical Periodontitis DENTAL IMPLANTATION Infected Extraction Socket

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura University

Al Mansurah, 35516, Egypt

About this study

Immediate implant placement has become a predictable treatment modality that shortens treatment time and helps preserve alveolar bone architecture. Although successful outcomes have been reported in chronically infected extraction sockets following meticulous debridement and infection control, the inflammatory environment may adversely affect early bone healing and osseointegration.

Melatonin (N-acetyl-5-methoxytryptamine) exhibits antioxidant, anti-inflammatory, antimicrobial, and osteogenic properties that may enhance peri-implant bone regeneration. Previous studies have suggested that topical melatonin can stimulate osteoblastic activity, increase bone formation, and improve implant stability. However, evidence regarding its effectiveness in immediate implant placement within chronically infected extraction sockets remains limited.

This study is designed as a quadruple-blinded, parallel-arm randomized controlled clinical trial involving 60 participants. Following atraumatic extraction, thorough socket debridement, immediate implant placement, and grafting of the peri-implant jumping gap, participants will be allocated to one of two treatment groups. In the experimental group, a sterile 2% melatonin gel will be applied to the implant surface and mixed with the grafting material before placement. Clinical and radiographic outcomes will be evaluated for 12 months following implant placement.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients aged 18-50 years.
  • Non-restorable teeth associated with chronic apical lesions persisting after previous endodontic treatment and/or periapical surgery.
  • Adequate interarch relationship and interocclusal space for prosthetic rehabilitation.
  • Expected peri-implant jumping gap ≥2 mm.
  • Good oral hygiene and willingness to comply with follow-up visits.
  • The chronic periapical lesion of a predefined radiographic size range of [4 - 10 mm], measured as the maximum lesion diameter on preoperative CBCT.

Exclusion criteria

  • Smokers.
  • Alcohol or drug abuse.
  • Pregnancy.
  • Systemic conditions contraindicating implant placement.
  • Bruxism or other parafunctional habits.
  • Inability or unwillingness to maintain oral hygiene or attend follow-up visits.

Treatment and study plan

Topical Melatonin

Drug

Participants will undergo immediate implant placement in chronically infected extraction sockets. A sterile 2% melatonin gel will be applied to the implant surface immediately before implant insertion and mixed with Si-β-TCP putty bone substitute prior to grafting of the peri-implant jumping gap.

Intervention: Topical Melatonin Gel 2%

Control

Other

Participants will undergo immediate implant placement in chronically infected extraction sockets followed by grafting of the peri-implant jumping gap with Si-β-TCP putty bone substitute alone.

Primary outcomes

  1. Implant Stability Quotient (ISQ)

    Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months after implant placement.

    Implant stability will be assessed using resonance frequency analysis (Osstell Mentor device). The mean value of four measurements obtained around each implant will be recorded.

Secondary outcomes

  1. Marginal Bone Loss

    Time frame: Baseline and 6 months.

    Marginal bone loss will be assessed using CBCT imaging by comparing crestal bone levels around implants.

  2. Relative Peri-implant Bone Density

    Time frame: 6 months.

    Relative peri-implant bone density will be evaluated using CBCT gray-value analysis.

  3. Postoperative Pain

    Time frame: Postoperative days 1, 3, and 7.

    Pain intensity will be evaluated using an 11-point Numeric Rating Scale (0-10).

  4. Soft Tissue Healing

    Time frame: 7 and 14 days postoperatively.

    Soft tissue healing will be evaluated using the Landry Wound Healing Index.

  5. Implant Survival

    Time frame: 12 months after implant placement.

    Implant survival will be defined as the implant remaining in situ and functional without mobility or removal.

  6. Postoperative Infection

    Time frame: 7 days, 14 days, and 4 weeks postoperatively.

    Presence or absence of infection will be assessed clinically.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Effect of Topical Melatonin on Osseointegration of Immediate Implants Placed in Chronically Infected Extraction Sockets: A Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

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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