- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07615361
Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy
Use of Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective clinical trial will include systemically healthy adult patients who require extraction of at least two posterior teeth with a hopeless prognosis due to periodontal disease, root caries, or root fractures, and who are candidates for implant-supported posterior rehabilitation. Following atraumatic tooth extraction, only sites with intact alveolar socket walls will be included.
Extracted teeth will be processed to obtain an autogenous odontogenic graft material. Eligible extraction sockets will be allocated to one of the study groups: (1) odontogenic graft alone or (2) odontogenic graft combined with adjunctive low-level laser therapy. In the laser group, LLLT will be applied according to a standardized protocol during the early healing period to promote cellular activity and bone regeneration.
Clinical and radiographic evaluations will be performed at baseline and at predefined follow-up intervals to assess soft tissue healing, bone dimensional changes, and quality of regenerated bone prior to implant placement. The primary outcome measure will be the amount and quality of newly formed bone, while secondary outcomes will include socket healing, postoperative morbidity, and implant feasibility.
The results of this study aim to provide clinical evidence on the potential benefits of combining autogenous tooth-derived grafts with low-level laser therapy for alveolar ridge preservation and to support optimized treatment protocols for implant-supported posterior rehabilitation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Uskudar
-
Istanbul, Uskudar, Turkey (Türkiye), 34668
- Health Sciences University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients requiring tooth extraction due to periodontal reasons (teeth with a hopeless prognosis), root caries, or root fractures, who are simultaneously candidates for posterior replacement with an osseointegrated implant, and who require extraction of at least two teeth.
- Integrity of the alveolar socket walls following tooth extraction.
- Patients who accept the study conditions, sign written informed consent, and agree to attend the scheduled follow-up visits.
Exclusion Criteria:
- General contraindications for dental and/or surgical treatments.
- Inflammatory or autoimmune diseases of the oral cavity.
- Uncontrolled diabetes mellitus (HbA1c > 7%).
- History of malignancy requiring chemotherapy or radiotherapy within the past 5 years.
- Previous treatment with immunosuppressive agents, bisphosphonates, or high-dose corticosteroids.
- Smoking more than 10 cigarettes per day.
- Pregnant or breastfeeding women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control Group
Dentin graft socket preservation
|
Autogenous Tooth-Derived Bone Graft prepared using the BonMaker® ATB device from extracted human teeth.
Following atraumatic tooth extraction, teeth will be mechanically ground and chemically processed according to the manufacturer's standardized protocol to obtain particulate autogenous graft material containing dentin and enamel components.
The graft material will be placed immediately into extraction sockets for alveolar ridge preservation prior to implant placement.
|
|
Experimental: Test Group
Dentin graft socket preservation+LLLT
|
Adjunctive low-level laser therapy (LLLT) performed using a 650 nm diode laser device (Woodpecker DTE D-Laser Blue) with a 6 mm fiber applicator in continuous contact mode at an output power of 25 mW and an energy density of 0.500 J/cm².
Laser irradiation will be applied to grafted extraction sockets immediately after extraction, after flap closure, and during postoperative follow-up visits according to a standardized treatment protocol to enhance soft tissue healing and bone regeneration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean change in horizontal alveolar ridge width (mm) from baseline to 4 months (CBCT)
Time Frame: Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)
|
Horizontal alveolar ridge width will be measured in millimeters using cone-beam computed tomography (CBCT) at baseline (immediately after tooth extraction) and at 4 months postoperatively prior to implant placement. The primary outcome will be defined as the mean change in ridge width (Δ width = width at 4 months - width at baseline), expressed in millimeters. |
Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean change in vertical alveolar ridge height (mm) from baseline to 4 months (CBCT)
Time Frame: Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]
|
Vertical alveolar ridge height will be measured in millimeters using cone-beam computed tomography (CBCT) at baseline (immediately after tooth extraction) and at 4 months postoperatively prior to implant placement. The secondary outcome will be defined as the mean change in ridge height (Δ height = height at 4 months - height at baseline), expressed in millimeters. |
Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Newly Formed Bone Measured by Histomorphometric Analysis of Bone Biopsy Specimens
Time Frame: Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]
|
Bone biopsy specimens obtained from grafted extraction sockets during implant placement surgery will be processed with hematoxylin and eosin (H&E) staining and evaluated under light microscopy.
Histomorphometric analysis will be used to quantify the percentage of newly formed bone within the biopsy samples.
|
Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 85
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Periodontal Diseases
-
Tel Aviv UniversityRecruitingPeriodontal Disease | Periodontal Attachment Loss | Periodontal PocketsIsrael
-
Riga Stradins UniversityUniversity of TurkuRecruitingPeriodontitis | Periodontal Diseases | Periodontal Bone Loss | Periodontal Disease | Periodontal Regeneration | Periodontal Healing | Periodontal Granulation Tissue | Vertical Periodontal Bone DefectsLatvia
-
Ohio State UniversityNot yet recruitingPeriodontal Disease | Periodontal SurgeryUnited States
-
G. d'Annunzio UniversityRecruitingPeriodontal Diseases | Intrabony Periodontal Defect | Periodontal Attachment Loss | Pocket, PeriodontalAlbania
-
University of Roma La SapienzaActive, not recruitingPeriodontal Disease | Periodontal Disease, AVDC Stage 3 | Periodontal Disease Stage 2Italy
-
Saglik Bilimleri UniversitesiRecruitingPeriodontitis | Periodontal Diseases | Periodontal Bone Loss | Intrabony Periodontal Defect | Periodontal DefectTurkey (Türkiye)
-
Siddharth ShanbhagUniversidad Complutense de MadridNot yet recruitingPeriodontal Disease | Intrabony Periodontal DefectsNorway, Spain
-
Kafrelsheikh UniversityActive, not recruitingPeriodontal Diseases | Periodontal Attachment LossEgypt
-
Krishnadevaraya College of Dental Sciences & HospitalCompletedPeriodontitis | Periodontal Attachment Loss | Periodontal Inflammation | Pocket, PeriodontalIndia
-
University of BeykentCompletedPeriodontal Diseases | Periodontal Attachment Loss | Periodontal Inflammation | Periodontal Disease, AVDC Stage 3 | Periodontal Disease, AVDC Stage 4Turkey
Clinical Trials on Autogenous Tooth-Derived Bone Graft
-
Semmelweis UniversityEnrolling by invitation
-
Kafrelsheikh UniversityCompletedPeri-Implantitis | Alveolar Bone Loss | Dental Implant Failure NosEgypt
-
Haifaa Mohammed Al-hussiniActive, not recruitingAlveolar Bone Grafting | Bone Regeneration Following Wisdom Teeth Extraction | Tooth Extraction Site HealingYemen
-
Tanta UniversityCompleted
-
Mahsa UniversityEnrolling by invitation
-
National University of MalaysiaNot yet recruitingBone Defects | Dentin Graft | Impacted Mandibular Third Molar Extraction | XenograftMalaysia
-
University of Bari Aldo MoroRecruitingTooth Diseases | Tooth Loss | Reimplant; ComplicationsItaly
-
Semmelweis UniversityRecruitingAlveolar Bone LossHungary
-
Cairo UniversityRecruitingIntrabony Periodontal DefectEgypt
-
Semmelweis UniversityActive, not recruitingCleft Lip and PalateHungary