IMMEDIATE IMPLANTS: GRAFT VS NO GRAFT

NCT07761195 | Not Yet Recruiting

• 1 other identifier: YYU-OMFS-2026-002
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month after immediate implant placement and 3 months after immediate implant placement

Secondary Outcomes (1)

• CHANGE IN FRACTAL DIMENSION VALUE MEASURED USING IMAGEJ SOFTWARE

  1 month and 3 months after immediate implant placement

Study Arms (2)

BONE GRAFT GROUP

EXPERIMENTAL

IMMEDIATE IMPLANT SITES RECEIVING GEN-OS BONE GRAFT MATERIAL FOLLOWING TOOTH EXTRACTION. BONE HEALING WILL BE EVALUATED USING FRACTAL ANALYSIS OF ROUTINE PANORAMIC RADIOGRAPHS OBTAINED AT 1 AND 3 MONTHS.

Procedure: BONE GRAFTING

NO BONE GRAFT GROUP

ACTIVE COMPARATOR

IMMEDIATE IMPLANT SITES WITHOUT BONE GRAFTING FOLLOWING TOOTH EXTRACTION. BONE HEALING WILL BE EVALUATED USING FRACTAL ANALYSIS OF ROUTINE PANORAMIC RADIOGRAPHS OBTAINED AT 1 AND 3 MONTHS.

Other: NO BONE GRAFT

Interventions

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.

BONE GRAFT GROUP

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.

NO BONE GRAFT GROUP

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• sema kaya: lead

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Central Study Contacts

SEMA KAYA, ASSOCIATE PROFESSOR

CONTACT

+905540062682; semakaya@yyu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR, DEPARTMENT OF ORAL AND MAXILLOFACIAL RADIOLOGY

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share