Evaluating a new bioceramic with statin for bone regeneration after tooth extraction
Clinical Study to Analyze the Osteogenic Action of a Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model (Galibone+) in Bone Regeneration Following the Extraction of Impacted Mandibular Third Molars
This study is testing a new bone treatment using a special bioceramic and a medication to see if it helps people heal better after having their wisdom teeth removed.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Santiago de Compostela Academic / other |
| Locations | 2 sites (Santiago De Compostela, A Coruña and 1 other locations) |
| Trial ID | NCT06338241 on ClinicalTrials.gov |
What this trial studies
This clinical study assesses the osteogenic effects of a biphasic bioceramic combined with simvastatin in promoting bone regeneration following the extraction of impacted mandibular third molars. Conducted as a double-blind, randomized split-mouth trial, it involves 30 patients who will receive either the experimental treatment or a standard material (Bio-Oss). The study will monitor clinical outcomes such as pain and inflammation, as well as radiological assessments of bone volume and mineral density over a six-month period. The aim is to determine the efficacy of the new treatment in enhancing recovery and improving surgical outcomes in dental procedures.
Who should consider this trial
Good fit: Ideal candidates are adults requiring extraction of both impacted mandibular third molars with similar complexity.
Not a fit: Patients with severe mental disorders or contraindications to dental surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve bone regeneration and recovery for patients undergoing third molar extractions.
How similar studies have performed: Other studies have shown promising results with similar bioceramic approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must be of legal age. * Participants must provide informed consent for participation in the study. * Participants must require extraction of both impacted mandibular third molars. * Both impacted molars must exhibit a similar level of complexity for extraction. * Participants must have no history of infection in the impacted molars prior to extraction. * Participants must not have any contraindications to undergoing oral surgical procedures (ASA I/II classification). Exclusion Criteria: * Participants with severe mental disorders that may impair their ability to provide informed consent or follow study instructions. * Participants currently receiving medications contraindicated for dental extractions. * Participants under the age of legal consent. * Participants who have undergone head and neck radiotherapy within the past 18 months.
Where this trial is running
Santiago De Compostela, A Coruña and 1 other locations
- Faculty of Dentistry of Universidade de Santiago de Compostela — Santiago De Compostela, A Coruña, Spain (Recruiting)
- Faculty of Dentistry University of Murcia — Murcia, Spain (Recruiting)
Study contacts
- Study coordinator: Mario Perez Sayans Garcia, Phd, Phd
- Email: mario.perez@usc.es
- Phone: +34626233504
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.