IMMEDIATE IMPLANTS: GRAFT VS NO GRAFT

N/ANot Yet RecruitingNCT07761195

sema kaya40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

BONE GRAFTINGPROCEDURE

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 GRAFTOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

FRACTAL DIMENSION VALUE MEASURED USING IMAGEJ SOFTWARE

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.

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

Secondary Outcomes

CHANGE IN FRACTAL DIMENSION VALUE MEASURED USING IMAGEJ SOFTWARE

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.

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