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

Suez Canal University

Status: Enrolling

Conditions: Dental Implants; Immediate Implant Placement; Osseointegration

Treatments: Drug: Melatonin gel; Procedure: Autologous Demineralized Dentin Graft

Study type: Interventional

Funder types: Other

Identifiers

NCT07610876

854/2024

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

ADDG Alone

Experimental group

Description:

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.

Treatment:

Procedure: Autologous Demineralized Dentin Graft

ADDG + Melatonin Gel

Experimental group

Description:

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.

Treatment:

Drug: Melatonin gel