Tooth ExtractionNCT07761195
IMMEDIATE IMPLANTS: GRAFT VS NO GRAFT
A study testing BONE GRAFTING and NO BONE GRAFT in people with Tooth Extraction and Immediate Dental Implant Placement, run by sema kaya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Tooth Extraction, Immediate Dental Implant Placement, Alveolar Bone Healing After Dental Extraction
- What is being tested?
- BONE GRAFTING and NO BONE GRAFT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: IMMEDIATE IMPLANTOLOGY: EFFECTS OF BONE GRAFTING ON MANDIBULAR BONE MICROSTRUCTURE USING FRACTAL ANALYSIS
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
- Being tested
- BONE GRAFTING, NO BONE GRAFT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BONE GRAFTINGProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: NO BONE GRAFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 1 month and 3 months after immediate implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- sema kaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, sema kaya, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761195
- Sponsor's protocol ID
- YYU-OMFS-2026-002
- Status last verified
- Apr 2026
- First submitted
- 4 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMMEDIATE IMPLANTOLOGY: EFFECTS OF BONE GRAFTING ON MANDIBULAR BONE MICROSTRUCTURE USING FRACTAL ANALYSIS
- ClinicalTrials.gov ID
- NCT07761195
- Acronym / sponsor ID
- YYU-OMFS-2026-002
- Conditions
- Tooth Extraction, Immediate Dental Implant Placement, Alveolar Bone Healing After Dental Extraction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- sema kayaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BONE GRAFT GROUP | Experimental | Procedure: BONE GRAFTINGIMMEDIATE 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. |
| NO BONE GRAFT GROUP | Active comparator | Other: NO BONE GRAFTIMMEDIATE 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BONE GRAFTINGGEN-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. | Procedure or surgery | BONE GRAFT GROUP |
| NO BONE GRAFTImmediate 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. | Other | NO BONE GRAFT GROUP |
Primary outcome
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.
1 secondary outcome
CHANGE IN FRACTAL DIMENSION VALUE MEASURED USING IMAGEJ SOFTWARE
Time frame: 1 month and 3 months after immediate implant placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing BONE GRAFTING and NO BONE GRAFT in people with Tooth Extraction and Immediate Dental Implant Placement, run by sema kaya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEMA KAYA, ASSOCIATE PROFESSOR (+905540062682, semakaya@yyu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FRACTAL DIMENSION VALUE MEASURED USING IMAGEJ SOFTWARE (time frame: 1 month after immediate implant placement and 3 months after immediate implant placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.