Assessment of the Impact of Neocement Inject P® (Beta-Tricalcium Phosphate) on Bone Volume in Alveolar Ridge Preservation After Tooth Extraction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neocement Inject P® (Beta-Tricalcium Phosphate).
- Who it may be relevant to
- Registry conditions: Tooth Extraction, Tooth Extraction Site Healing, Alveolar Bone Grafting, Alveolar Bone Loss. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Safety and Performance of Neobone®: A Prospective Observational Study in the Field of Dentistry
Overview
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.
Interventions
- Device Neocement Inject P® (Beta-Tricalcium Phosphate)
After tooth extraction the socket will be grafted with Neocement Inject P® (Beta-Tricalcium Phosphate).
Primary outcome measures
- Change in alveolar ridge volume after tooth extraction [Time frame: From enrollment to the end of treatment at 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Portugal · 1 center
- Clinica Dentária Egas Moniz — Caparica
Publications
- Mishchenko O, Yanovska A, Kosinov O, Maksymov D, Moskalenko R, Ramanavicius A, Pogorielov M. Synthetic Calcium-Phosphate Materials for Bone Grafting. Polymers (Basel). 2023 Sep 19;15(18):3822. doi: 10.3390/polym15183822. PMID 37765676
Identifiers
NCT: NCT07638319 · EM1651