Laser TherapyNCT07615361
Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy
A study testing Autogenous Tooth-Derived Bone Graft and Low-Level Laser Therapy (LLLT) in people with Laser Therapy and Periodontal Diseases, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
This clinical trial aims to evaluate the effectiveness of an odontogenic graft obtained from extracted human teeth, with and without adjunctive low-level laser therapy (LLLT), on bone regeneration following posterior tooth extraction in systemically healthy adult patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laser Therapy, Periodontal Diseases, Bone Loss in Jaw
- What is being tested?
- Autogenous Tooth-Derived Bone Graft and Low-Level Laser Therapy (LLLT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2026to 1 Sep 2026
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Health Sciences University
Istanbul, Uskudar, 34668
About this study
Official title: Use of Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy
This clinical trial aims to evaluate the effectiveness of an odontogenic graft obtained from extracted human teeth, with and without adjunctive low-level laser therapy (LLLT), on bone regeneration following posterior tooth extraction in systemically healthy adult patients. The study investigates whether the combination of autogenous tooth-derived graft material and LLLT enhances alveolar bone healing and preservation compared to grafting alone, prior to implant-supported posterior rehabilitation.
Read the 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.
- Conditions
- Laser Therapy, Periodontal Diseases, Bone Loss in Jaw, Alveolar Bone Loss, Periodontal Bone Loss, Periodontal Atrophy
- Being tested
- Autogenous Tooth-Derived Bone Graft, Low-Level Laser Therapy (LLLT)
- Medical subject headings
- Periodontal Diseases, Alveolar Bone Loss, Periodontal Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenous Tooth-Derived Bone GraftBiological
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.
Low-Level Laser Therapy (LLLT)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Dentin graft socket preservation Receives: Biological: Autogenous Tooth-Derived Bone Graft |
| Test Group | Experimental | Dentin graft socket preservation+LLLT Receives: Device: Low-Level Laser Therapy (LLLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in horizontal alveolar ridge width (mm) from baseline to 4 months (CBCT)
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.
Measured: Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)
Secondary outcomes (1)
Mean change in vertical alveolar ridge height (mm) from baseline to 4 months (CBCT)
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.
Measured: Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start2 Feb 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laser TherapyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Toraman, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615361
- Sponsor's protocol ID
- 85
- Status last verified
- May 2026
- First submitted
- 23 Feb 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy
- ClinicalTrials.gov ID
- NCT07615361
- Acronym / sponsor ID
- 85
- Conditions
- Laser Therapy, Periodontal Diseases, Bone Loss in Jaw, Alveolar Bone Loss, Periodontal Bone Loss, Periodontal Atrophy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 29 May 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 clinical trial aims to evaluate the effectiveness of an odontogenic graft obtained from extracted human teeth, with and without adjunctive low-level laser therapy (LLLT), on bone regeneration following posterior tooth extraction in systemically healthy adult patients. The study investigates whether the combination of autogenous tooth-derived graft material and LLLT enhances alveolar bone healing and preservation compared to grafting alone, prior to implant-supported posterior rehabilitation.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Biological: Autogenous Tooth-Derived Bone GraftDentin graft socket preservation |
| Test Group | Experimental | Device: Low-Level Laser Therapy (LLLT)Dentin graft socket preservation+LLLT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Autogenous Tooth-Derived Bone GraftAutogenous 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. | Biological | Control Group |
| Low-Level Laser Therapy (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. | Device | Test Group |
Primary outcome
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.
1 secondary outcome
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)]
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 29 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenous Tooth-Derived Bone Graft and Low-Level Laser Therapy (LLLT) in people with Laser Therapy and Periodontal Diseases, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 29 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.