Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy
Use of Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
Uskudar
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Istanbul, Uskudar, Turquie (Türkiye), 34668
- Health Sciences University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Control Group
Dentin graft socket preservation
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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.
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Expérimental: Test Group
Dentin graft socket preservation+LLLT
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean change in horizontal alveolar ridge width (mm) from baseline to 4 months (CBCT)
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean change in vertical alveolar ridge height (mm) from baseline to 4 months (CBCT)
Délai: 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)]
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Newly Formed Bone Measured by Histomorphometric Analysis of Bone Biopsy Specimens
Délai: Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]
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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.
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Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 85
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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