NCT07615361

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Feb 2026Sep 2026

Study Start

First participant enrolled

February 2, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

February 23, 2026

Last Update Submit

May 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]

Other Outcomes (1)

  • Percentage of Newly Formed Bone Measured by Histomorphometric Analysis of Bone Biopsy Specimens

    Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]

Study Arms (2)

Control Group

EXPERIMENTAL

Dentin graft socket preservation

Biological: Autogenous Tooth-Derived Bone Graft

Test Group

EXPERIMENTAL

Dentin graft socket preservation+LLLT

Device: Low-Level Laser Therapy (LLLT)

Interventions

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.

Control Group

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.

Test Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences University

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal DiseasesAlveolar Bone LossPeriodontal Atrophy

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesBone ResorptionBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 23, 2026

First Posted

May 29, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

May 29, 2026

Record last verified: 2026-05

Locations