Assessment of the Impact of Neobone® (Biphasic Calcium Phosphate) on Bone Volume in Alveolar Ridge Preservation After Tooth Extraction

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEgas Moniz - Cooperativa de Ensino Superior, CRL

About this trial

The goal of this randomized clinical trial is to assess whether BCP (Biphasic Calcium Phosphate) improves alveolar ridge preservation (ARP) in patients who need tooth extraction. The main question it aims to answer is whether using BCP for alveolar ridge preservation has a positive effect on bone volume compared with natural healing.

The main questions it aims to answer are:

Does BCP improve ridge preservation compared with natural healing?

Researchers will compare BCP grafted sockets to natural healing sockets to see if BCP better preserves ridge volume.

Participants will:

Have a tooth indicated for extraction.

Be assigned to either BCP 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years or older

Acceptance of informed consent

Type 1 or 2 extraction sockets (Elian et al. 2007)

Disqualifiers

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%)

Trial design

Design model

Single group

Treatments tested in this trial

  • Neobone® (Biphasic Calcium Phosphate)

    Device

    After tooth extraction the socket will be grafted with Neobone® (Biphasic Calcium Phosphate)

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Neobone® (Biphasic Calcium Phosphate)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in alveolar ridge volume after tooth extraction

Change in alveolar ridge volume after tooth extraction on sockets grafted with Biphasic Calcium Phosphate

Time frame
From enrollment to the end of treatment at 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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