Assessment of the Impact of Neocement Inject P® (Beta-Tricalcium Phosphate) on Bone Volume in Alveolar Ridge Preservation After Tooth Extraction (BTCPARPBV)
Assessment of Safety and Performance of Neobone®: A Prospective Observational Study in the Field of Dentistry
The goal of this randomized clinical trial is to assess whether β-TCP (Beta-Tricalcium Phosphate) improves alveolar ridge preservation (ARP) in patients who need tooth extraction. The main question it aims to answer is whether using β-TCP for alveolar ridge preservation has a positive effect on bone volume compared with natural healing.
The main questions it aims to answer are:
Does β-TCP improve ridge preservation compared with natural healing?
Researchers will compare β-TCP grafted sockets to natural healing sockets to see if β-TCP better preserves ridge volume.
Participants will:
Have a tooth indicated for extraction.
Be assigned to either β-TCP or natural healing.
Undergo CBCT (Cone Beam Computed Tomography) and intra-oral scanning after extraction and after six months of healing to measure horizontal and vertical resorption and bone density.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Angel Lobito, Masters' in Dentistry
- Telefonnummer: 00351924347050
- E-mail: alobito@egasmoniz.edu.pt
Studiesteder
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Monte Da Caparica
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Caparica, Monte Da Caparica, Portugal, 2829-511
- Rekruttering
- Clinica Dentária Egas Moniz
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Kontakt:
- Angel Lobito, Masters' in Dentistry
- Telefonnummer: 00351924347050
- E-mail: alobito@egasmoniz.edu.pt
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 18 years or older
- Acceptance of informed consent
- Type 1 or 2 extraction sockets (Elian et al. 2007)
Exclusion Criteria:
- Presence of active infection or severe inflammation in the intervention zone
- Relevant medical history that contraindicates implant surgery
- Patients with poor oral hygiene (full-mouth plaque score and full-mouth bleeding score >15%) and lack of motivation
- Uncontrolled diabetes (reported levels of glycated haemoglobin exceeding 7%)
- Uncontrolled and /or untreated periodontal disease
- Heavy smokers (more than 10 cigarettes per day)
- Immunosuppression
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Neocement Inject P® (Beta-Tricalcium Phosphate)
After tooth extraction the socket will be grafted with Neocement Inject P® (Beta-Tricalcium Phosphate).
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After tooth extraction the socket will be grafted with Neocement Inject P® (Beta-Tricalcium Phosphate).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in alveolar ridge volume after tooth extraction
Tidsramme: From enrollment to the end of treatment at 6 months
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Change in alveolar ridge volume after tooth extraction on sockets grafted with Beta-Tricalcium Phosphate
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From enrollment to the end of treatment at 6 months
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Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: João Botelho, PhD in Biomedical Sciences, Clinical Research Unit (CRU), Egas Moniz Center for Interdisciplinary Research (CiiEM), Egas Moniz School of Health & Science
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EM1651
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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