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Effect of simvastatin 20mg in bone formation after Removal of lower third molar teeth

Efficacy of simvastatin 20mg on bone regeneration after lower third molar extraction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-523n7r
Enrollment
Unknown
Registered
2020-02-20
Start date
2019-07-08
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

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Interventions

D02.455.426.559.847.638.400.900
This is a randomized, double-blind, split-mouth clinical trial to assess the osteoinductive action of 20mg simvastatin, using the post-extraction socket of the lower third molars as a study model. On
on the control side (group B) only the clot remained. A total of 22 patients underwent two extractions of third molars at the same surgical time, each performed in different sides of the mandible. All
Drug
Procedure/surgery

Sponsors

Faculdade de Odontologia de Pernambuco, Universidade de Pernambuco - UPE
Lead Sponsor
Universidade Federal de Pernambuco
Collaborator

Eligibility

Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria were as follows: adult patients aged between 18-40 years old, of both genres, of any ethnicity, healthy, without allergy to the drugs used in the research or its components and who are not using any other medication. All patients must have both lower third molars, included, with the same inclusion pattern according to the Pell & Gregory classification, healthy, with indication of extraction and without signs of pericoronitis or inflammation.

Exclusion criteria

Exclusion criteria: The exclusion criteria were: patients with an inability to open their mouth for surgery; exceed 40 minutes in any surgery; fracture or postoperative infection; recent history of chemotherapy and / or radiation to the head and neck; giving up participating in the research at some point; make use of medications that have a known interaction with any drugs used in the study; smokers, pregnant or lactating women; did not perform the tests requested in the postoperative period.

Design outcomes

Primary

MeasureTime frame
The bone volume, verified by the analysis of 2 cone-beam scans for each patient, based on the observation of a variation of at least 4.23 mm³ in favor of the intervention group.;The Percentage of bone volume (BV / TV), verified by analysis of 2 cone-beam tomographies for each patient, based on the observation of a variation of at least 0.07 mm³ in favor of the intervention group.

Secondary

MeasureTime frame
The pain was verified using the visual analog scale (VAS), based on the observation of a significant difference between the groups at the following times: 2, 4, 6, 8, 24, 48 and 72h (p <0.05).;The swelling, verified through the evaluation through the measurement of three facial measures, from the verification of a variation of at least 2.23mm in favor of the test group after 72h.;Alveolar healing, verified through the Landry index, based on the finding of a worse local tissue repair profile in the test group (p <0.01) compared to the control group.

Countries

Brazil

Contacts

Public ContactJiordanne Diniz

Faculdade de Odontologia de Pernambuco, Universidade de Pernambuco - UPE

jiordannediniz18@hotmail.com+55-081-979064365

Outcome results

None listed

Source: REBEC (via WHO ICTRP)