Bone preservation after molar extraction using laser and grafting
Evaluation of Alveolar Bone Preservation After Early Molar Extraction Using Photobiomodulation Combined With Grafting With Scaffold Biomaterial: Clinical, Randomized, Triple-blind Study.
This study is testing whether using a laser and special grafting materials after tooth extraction can help preserve bone better for adults who have had their molars removed.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Nove de Julho Academic / other |
| Locations | 1 site (São Paulo, SP) |
| Trial ID | NCT06164626 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of photobiomodulation combined with biomaterial grafting in preserving bone after the extraction of first and second permanent molars. It involves 60 patients aged 18 and older who will be randomized into four groups: extraction only, extraction with laser treatment, extraction with biomaterial grafting, and extraction with both grafting and laser treatment. The study aims to develop a protocol that enhances bone healing and integration of graft materials using an 808 nm infrared laser. The outcomes will help determine the best approach for managing alveolar bone preservation post-extraction.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who require extraction of first or second permanent molars and have no significant comorbidities.
Not a fit: Patients with ongoing neurological or psychiatric treatments, current smoking habits, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve bone healing and reduce deformities after tooth extraction.
How similar studies have performed: While the combination of photobiomodulation and biomaterial grafting is promising, further research is needed to establish its efficacy, as similar approaches have shown mixed results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All genders, * Aged over 18 years, * Without comorbidities, * Present satisfactory oral hygiene, * Present a condition of loss of first or second permanent molar. Exclusion Criteria: * Habitual use of analgesic and anti-inflammatory medication for other comorbidities, * Present allergies to the proposed drug protocol, * In neurological/psychiatric treatment, * Presence of teeth with lesions to be treated in the same hemiarch of the tooth to be removed, * Current smoking habit, * Pregnant or breast-feeding, * Presenting photosensitivity disorders, * With the presence of neoplasia in the oral region, * Patients with operative complications whose surgical time exceeds 90 minutes
Where this trial is running
São Paulo, SP
- Uniersidade Nove de Julho — São Paulo, Sp, Brazil (Recruiting)
Study contacts
- Study coordinator: Sandra Kalil Bussadori, PhD
- Email: sandra.skb@gmail.com
- Phone: 551132283400
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.