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NCT Number: NCT07610876

Autologous Demineralized Dentin Graft With or Without Melatonin for Immediate Implant Osseointegration

This randomized clinical study aims to evaluate the effect of autologous demineralized dentin graft (ADDG) with or without melatonin gel on the osseointegration of immediately placed dental implants in the maxillary premolar region. Sixteen patients requiring extraction and immediate implant placement will be randomly allocated into two groups. Clinical and radiographic outcomes including implant stability, peri-implant probing depth, modified bleeding index, marginal bone loss, buccal bone thickness, and bone density will be evaluated over a 9-month follow-up period.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University, Faculty of Dentistry

Ismailia, Egypt

Location status: Recruiting

Location contact

Dean, Faculty of Dentistry, Suez Canal University

CONTACT

[email protected]

(+2064) 3223007

About this study

Patients requiring extraction and immediate implant placement in the maxillary premolar region often present with peri-implant defects and jumping gaps that may compromise osseointegration and long-term implant success. Autogenous bone grafts are considered the gold standard for bone augmentation because of their osteogenic, osteoinductive, and osteoconductive properties; however, they are associated with donor-site morbidity, limited availability, and increased surgical time. Recently, autologous demineralized dentin graft (ADDG) derived from extracted teeth has been introduced as a promising alternative grafting material due to its chemical and histological similarity to alveolar bone.

Dentin and bone share a common embryologic origin and similar composition, including type I collagen and low crystalline hydroxyapatite. Demineralized dentin graft material has demonstrated favorable osteoconductive and osteoinductive properties and has been successfully used in guided bone regeneration and immediate implant procedures. In immediate implant placement, the extracted tooth may be processed and reused as graft material to fill the jumping gap around the implant.

Melatonin (N-acetyl-5-methoxytryptamine) is an antioxidant molecule that has demonstrated beneficial effects on bone metabolism and osseointegration. Melatonin reduces osteoclastic activity, promotes osteoblast differentiation, enhances bone formation, and decreases oxidative stress during healing. Previous studies have suggested that local application of melatonin around dental implants may improve early osseointegration and bone healing.

The purpose of this randomized clinical study is to evaluate clinically and radiographically the effect of using melatonin gel in conjunction with autologous demineralized dentin graft on the osseointegration of immediately placed implants.

Sixteen patients with non-restorable maxillary premolar teeth indicated for extraction and immediate implant placement will be recruited from the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University. Eligible patients will be randomly allocated into two equal groups. In Group I, immediate implants will be placed and the jumping gap will be filled using autologous demineralized dentin graft alone. In Group II, immediate implants will be placed and the jumping gap will be filled using autologous demineralized dentin graft mixed with melatonin gel.

Clinical assessment will include implant stability measurement using the Penguin device, peri-implant sulcus depth, and modified bleeding on probing index. Radiographic evaluation will be performed using cone beam computed tomography (CBCT) to assess marginal bone loss, buccal bone thickness, buccal bone height, jumping distance, and bone density at baseline, immediately after implant placement, and during follow-up periods up to 9 months postoperatively.

The results of this study may help determine whether the addition of melatonin gel to autologous demineralized dentin graft improves osseointegration and peri-implant bone healing in immediate implant placement procedures.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age above 20 years
  • Non-restorable maxillary premolar teeth
  • Candidates for immediate implant placement
  • Intact socket walls
  • Jumping gap >2 mm
  • Non-smokers or light smokers
  • No acute infection
  • Adequate bone for primary stability

Exclusion criteria

  • Heavy smokers
  • Bruxism or clenching
  • Uncontrolled systemic disease
  • Chemotherapy/radiotherapy
  • Immunocompromised patients

Treatment and study plan

Autologous Demineralized Dentin Graft

Procedure

Autologous demineralized dentin graft prepared from extracted non-restorable teeth will be used for filling the jumping gap around immediately placed dental implants. Tooth preparation includes removal of restorations, caries, periodontal ligament, pulp tissue, calculus, and cementum, followed by grinding and demineralization using 2% nitric acid before graft placement.

Melatonin gel

Drug

Melatonin gel will be mixed with autologous demineralized dentin graft and used for filling the jumping gap around immediately placed dental implants in the maxillary premolar region to enhance osseointegration and peri-implant bone healing.

Primary outcomes

  1. Implant Stability Quotient (ISQ)

    Time frame: Baseline and 6 months

    Measured using Penguin device immediately after implant placement and after 6 months.

  2. Jumping Distance

    Time frame: Immediate postoperative and 9 months after implant placement

    The horizontal bucco-implant gap (jumping distance) will be measured radiographically using CBCT at 0 mm, 2 mm, and 5 mm apical to the implant shoulder as the perpendicular distance from the implant surface to the inner buccal bone plate.

  3. Marginal Bone Loss

    Time frame: Immediate postoperative and 9 months after implant placement

    Marginal bone loss will be assessed radiographically using cone beam computed tomography (CBCT) as the vertical distance from the implant platform to the alveolar crest around the implant.

  4. Bone Density

    Time frame: Immediate postoperative and 9 months after implant placement

    Bone density around the implant will be measured radiographically using CBCT and expressed in Hounsfield units (HU) to evaluate peri-implant bone maturation and osseointegration.

Secondary outcomes

  1. Buccal Bone Thickness (BBT)

    Time frame: Preoperative, immediate postoperative, and 9 months after implant placement

    Buccal bone thickness will be measured radiographically using standardized CBCT scans at 0 mm, 2 mm, and 5 mm apical to the implant shoulder to evaluate horizontal buccal bone dimensional changes around immediately placed implants.

  2. Buccal Bone Height (BBH)

    Time frame: Preoperative, immediate postoperative, and 9 months after implant placement

    Buccal bone height will be assessed radiographically using CBCT as the vertical distance from the implant shoulder to the most coronal buccal bone point.

  3. Peri-Implant Sulcus Depth (PISD)

    Time frame: Baseline, 6 months, and 9 months

    Peri-implant sulcus depth will be measured clinically using a periodontal probe at the buccal, palatal, mesial, and distal aspects around the implant.

  4. Modified Bleeding on Probing Index (MBOP)

    Time frame: Baseline, 6 months, and 9 months

    Modified bleeding on probing index will be recorded clinically using a periodontal probe to evaluate peri-implant soft tissue inflammation around the implant.

Study contacts

Contact information is provided by the study sponsor or research team.

B.S.D Abd El Fattah ELSaid Attia

CONTACT

[email protected]

+20100465932

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

Effect of Autologous Demineralized Dentin Graft With or Without Melatonin Gel on the Osseo Integration of Immediately Placed Implants: A Randomized Clinical Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 28, 2026
Registry last updated
May 28, 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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