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

NCT07610876 | Recruiting

• 1 other identifier: 854/2024
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Melatonin; Dentin graft; Immediate implant; ADDG; Osseointegration; CBCT; Dental implant stability

Outcome Measures

Primary Outcomes (4)

• Implant Stability Quotient (ISQ)

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

  Baseline and 6 months

• Jumping Distance

  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.

  Immediate postoperative and 9 months after implant placement

• Marginal Bone Loss

  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.

  Immediate postoperative and 9 months after implant placement

• Bone Density

  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.

  Immediate postoperative and 9 months after implant placement

Secondary Outcomes (4)

• Buccal Bone Thickness (BBT)

  Preoperative, immediate postoperative, and 9 months after implant placement

• Buccal Bone Height (BBH)

  Preoperative, immediate postoperative, and 9 months after implant placement

• Peri-Implant Sulcus Depth (PISD)

  Baseline, 6 months, and 9 months

• Modified Bleeding on Probing Index (MBOP)

  Baseline, 6 months, and 9 months

Study Arms (2)

ADDG Alone

EXPERIMENTAL

Participants in this arm will receive immediate implant placement in the maxillary premolar region with jumping gap filling using autologous demineralized dentin graft (ADDG) alone after extraction of non-restorable teeth. Clinical and radiographic evaluation will be performed during the follow-up period.

Procedure: Autologous Demineralized Dentin Graft

ADDG + Melatonin Gel

EXPERIMENTAL

Participants in this arm will receive immediate implant placement in the maxillary premolar region with jumping gap filling using autologous demineralized dentin graft (ADDG) mixed with melatonin gel after extraction of non-restorable teeth. Clinical and radiographic evaluation will be performed during the follow-up period.

Drug: Melatonin gel

Interventions

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.

ADDG Alone

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.

ADDG + Melatonin Gel

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University, Faculty of Dentistry

Ismailia, Egypt

RECRUITING

Study Officials

• Hany Kamel Shalaby

  Professor of Oral Medicine and Periodontology, Dean Faculty of Dentistry

  STUDY CHAIR

• Shaima Mohammed Morsy

  Assistant Professor of Oral Medicine and Periodontology

  STUDY DIRECTOR

• Rasha El-Sayed Afifi

  Lecturer of Oral Medicine and Periodontology

  STUDY DIRECTOR

• Abd El Fattah ELSaid Attia, B.S.D

  B.S.D

  PRINCIPAL INVESTIGATOR

Central Study Contacts

B.S.D Abd El Fattah ELSaid Attia

CONTACT

+20100465932; PGS.230043@dent.suez.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Abd El Fattah ELSaid Attia Mowafy

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 28, 2026
• Study Start: August 11, 2025
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

EG (1)