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IMMEDIATE IMPLANTS: GRAFT VS NO GRAFT

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07761195
Enrollment
40
Registered
2026-08-12
Start date
2026-09-01
Completion date
2027-06-01
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

PROCEDUREBONE GRAFTING

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.

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.

Sponsors

sema kaya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
FRACTAL DIMENSION VALUE MEASURED USING IMAGEJ SOFTWARE1 month after immediate implant placement and 3 months after immediate implant placementFractal 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

MeasureTime frameDescription
CHANGE IN FRACTAL DIMENSION VALUE MEASURED USING IMAGEJ SOFTWARE1 month and 3 months after immediate implant placementFractal 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.

Contacts

CONTACTSEMA KAYA, ASSOCIATE PROFESSOR
semakaya@yyu.edu.tr+905540062682

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026