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Evaluation of the effectiveness and safety of a health product.

Double blind controlled clinical study for biological evaluation of Calcium Phosphate and Synthetic Biopolymers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-324wqpv
Enrollment
Unknown
Registered
2021-06-28
Start date
2021-08-23
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental caries

Interventions

After administration of local anesthesia, intrasulcular and crest incisions will be performed to allow exposure of the roots and the alveolar crest. The detachments periosteal mucus will be performed

Sponsors

DentsCare Ltda.
Lead Sponsor
DentsCare Ltda.
Collaborator

Eligibility

Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Healthy patients; older than 20 years and with a maximum age of 60 years; do not present any disease at the moment; not using any medication that may alter or compromise the bone healing response (medication for diabetes, autoimmune dysfunction, prolonged corticosteroid therapy or chemotherapy), they cannot be smokers and if in the case of ex-smokers, they must be at least 6 months without smoking before the study); patient should not report a history of anxiety, mood, eating and / or psychotic disorders that could compromise their participation and collaboration in the study

Exclusion criteria

Exclusion criteria: Age less than 20 years and more than 60 years; pregnant volunteers; drinkers; active smokers; diabetics; osteoporosis patients; participants using medication that can alter or compromise the bone healing response such as prolonged use of corticosteroids and bisphosphonates.

Design outcomes

Primary

MeasureTime frame
Assess whether there will be recovery of bone tissue lost after tooth extraction in the studied groups, through histomorphometric evaluation and imaging tests.

Secondary

MeasureTime frame
Perform the quantification of bone formed in sites filled with synthetic biomaterial from group 1 (G1) using synthetic biomaterial or similarity in groups

Countries

Brazil

Contacts

Public ContactBruno Paim
bruno.paim@fgm.ind.br+55 47 34416147

Outcome results

None listed

Source: REBEC (via WHO ICTRP)