- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07573761
Evaluation of the Effectiveness of Odontogenic Grafts Obtained From Human Teeth on Bone Formation
Socket Preservation and Odontogenic Graft Obtained From Human Tooth
Tooth extraction triggers a cascade of biological events mediated by the local inflammatory response following surgical intervention and by the loss of masticatory stimulation to the periodontium. These factors disrupt the homeostasis and structural integrity of the periodontal tissues. Following tooth loss, bone remodeling is initiated and continues for several months, with the majority of dimensional and morphological changes occurring within the first three months. This early alveolar bone resorption may compromise future implant placement and prosthetic rehabilitation.
Previous studies by Schmidt-Schultz and Schultz have demonstrated that biologically intact growth factors can be preserved within the collagenous extracellular matrix of ancient human bone and teeth. These findings suggest that stored dentin may retain biologically active growth factors and provide regenerative benefits comparable to those of freshly prepared dentin, while eliminating the need for simultaneous multiple surgical interventions. Moreover, the volume of particulate dentin exceeds twice the original root volume, allowing for the acquisition of sufficient graft material for clinical application.
Based on these biological and volumetric advantages, the use of autogenous stored mineralized dentin grafts (ASMDG) has emerged as a promising approach for alveolar socket preservation. ASMDG may contribute to limiting post-extraction alveolar ridge resorption and maintaining ridge dimensions during the critical early healing period.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
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Uskudar
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Istanbul, Uskudar, Turecko (Türkiye), 34668
- Health Sciences University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Study Group
Dentin graft socket preservation
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Control Group
Spontaneous healing
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Mean change in horizontal alveolar ridge width (mm) from baseline to 4 months (CBCT)
Časové okno: Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)
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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)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Mean change in vertical alveolar ridge height (mm) from baseline to 4 months (CBCT)
Časové okno: Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)
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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)
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 24/4
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