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Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy

22 maj 2026 uppdaterad av: Ayşe Toraman, Istanbul Saglik Bilimleri University

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.

Studieöversikt

Status

Anmälan via inbjudan

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

21

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Turkiet (Türkiye)
    • Uskudar
      • Istanbul, Uskudar, Turkiet (Türkiye), 34668
        • Health Sciences University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Control Group
Dentin graft socket preservation
Biologisk: Autogenous Tooth-Derived Bone Graft
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.
Experimentell: Test Group
Dentin graft socket preservation+LLLT
Enhet: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean change in horizontal alveolar ridge width (mm) from baseline to 4 months (CBCT)
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean change in vertical alveolar ridge height (mm) from baseline to 4 months (CBCT)
Tidsram: 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)]

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Newly Formed Bone Measured by Histomorphometric Analysis of Bone Biopsy Specimens
Tidsram: 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)]

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Istanbul Saglik Bilimleri University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

2 februari 2026

Primärt slutförande (Beräknad)

1 augusti 2026

Avslutad studie (Beräknad)

1 september 2026

Studieregistreringsdatum

Först inskickad

23 februari 2026

Först inskickad som uppfyllde QC-kriterierna

22 maj 2026

Första postat (Faktisk)

29 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 85

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Ja

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