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

NCT07610876 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-05-28

No results posted yet for this study

Summary

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.

Conditions

  • Dental Implants
  • Immediate Implant Placement
  • Osseointegration

Interventions

PROCEDURE

Autologous Demineralized Dentin Graft

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.

DRUG

Melatonin gel

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.

Sponsors & Collaborators

  • Suez Canal University

    lead OTHER

Principal Investigators

  • Hany Kamel Shalaby · Professor of Oral Medicine and Periodontology, Dean Faculty of Dentistry

  • Shaima Mohammed Morsy · Assistant Professor of Oral Medicine and Periodontology

  • Rasha El-Sayed Afifi · Lecturer of Oral Medicine and Periodontology

  • Abd El Fattah ELSaid Attia, B.S.D · B.S.D

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2026-10-10
Completion
2026-11-10

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07610876 on ClinicalTrials.gov