IMMEDIATE IMPLANTS: GRAFT VS NO GRAFT

This prospective, randomized, controlled, split-mouth clinical trial aims to evaluate the effect of bone grafting on mandibular bone microstructure following immediate implant placement using fractal analysis of panoramic radiographs. Forty systemically healthy adults requiring bilateral immediate implant placement in the mandibular anterior region will be enrolled. In each participant, one implant site will receive a bone graft (Gen-Os), while the contralateral site will serve as the non-grafted control. Panoramic radiographs obtained during routine postoperative follow-up at 1 and 3 months will be analyzed using ImageJ software to calculate fractal dimension values. The primary outcome is the comparison of fractal dimension values between grafted and non-grafted implant sites. The results are expected to provide evidence regarding the effect of bone grafting on early bone healing and microstructural changes following immediate implant placement.

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Key information

Conditions

Tooth Extraction Alveolar Bone Healing After Dental Extraction Immediate Dental Implant Placement

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adults aged 18 to 40 years. Requiring bilateral immediate implant placement in the mandibular anterior region.

Indication for tooth extraction in the mandibular anterior region. Systemically healthy (ASA I). Adequate bone volume for immediate implant placement. Willing and able to attend the scheduled follow-up visits. Routine panoramic radiographs suitable for fractal analysis. Provided written informed consent.

Exclusion criteria

Age younger than 18 years or older than 40 years. Systemic diseases affecting bone metabolism. Uncontrolled diabetes mellitus, osteoporosis, or other metabolic bone disorders.

Current use of bisphosphonates, corticosteroids, immunosuppressive drugs, or other medications affecting bone healing.

Pregnancy or breastfeeding. Active infection at the implant site. Heavy smoking or tobacco use. Previous radiotherapy to the head and neck region. Inadequate bone volume preventing immediate implant placement. Inability to attend follow-up visits. Refusal or inability to provide written informed consent.

Treatment and study plan

Bone grafting

Procedure

GEN-OS BONE GRAFT MATERIAL WILL BE PLACED IN THE EXTRACTION SOCKET DURING IMMEDIATE IMPLANT PLACEMENT ACCORDING TO THE STUDY PROTOCOL. NO ADDITIONAL EXPERIMENTAL PROCEDURES WILL BE PERFORMED.

NO BONE GRAFT

Other

Immediate implant placement without bone grafting following tooth extraction. Bone healing will be evaluated using fractal analysis of routine panoramic radiographs obtained at 1 and 3 months.

Primary outcomes

FRACTAL DIMENSION VALUE MEASURED USING IMAGEJ SOFTWARE

Time frame: 1 month after immediate implant placement and 3 months after immediate implant placement

Fractal dimension values of the peri-implant bone will be measured on digital panoramic radiographs using ImageJ software. Fractal dimension is a unitless numerical parameter used to assess trabecular bone microstructure. Higher values indicate greater trabecular complexity.

Secondary outcomes

CHANGE IN FRACTAL DIMENSION VALUE MEASURED USING IMAGEJ SOFTWARE

Time frame: 1 month and 3 months after immediate implant placement

Fractal dimension values of the peri-implant bone will be measured on digital panoramic radiographs using ImageJ software. The change in fractal dimension values between the 1-month and 3-month assessments will be evaluated separately for grafted and non-grafted implant sites.

Study contacts

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

SEMA KAYA, ASSOCIATE PROFESSOR

CONTACT

[email protected]

+905540062682

Sponsors and collaborators

Lead sponsor

sema kaya

Other

Registry information

Official study title

IMMEDIATE IMPLANTOLOGY: EFFECTS OF BONE GRAFTING ON MANDIBULAR BONE MICROSTRUCTURE USING FRACTAL ANALYSIS

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Aug 12, 2026
Registry last updated: Aug 12, 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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