Health Sciences University
Istanbul, Uskudar, 34668, Turkey (Türkiye)
NCT Number: NCT07615361
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Istanbul, Uskudar, 34668, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
Istanbul Saglik Bilimleri University
Other
Use of Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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