Augmenting bone in tooth extraction sites
Extraction Socket Augmentation Using GTO vs. Apatos. A Randomized Controlled Clinical Study
This study tests which of two different bone graft materials helps people who need tooth extractions grow more bone for dental implants.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universidad de Granada Academic / other |
| Locations | 1 site (Granada) |
| Trial ID | NCT06378112 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two different bone graft materials used during guided bone regeneration procedures for patients requiring tooth extraction and subsequent implant placement. Participants will be divided into two groups: one receiving GTO® as the graft material and the other receiving Apatos Mix®. The study aims to compare the amount of bone regeneration and the histological outcomes between the two graft materials in cases where there is significant loss of the buccal ridge wall. All materials used are commercially available and approved for human use.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old in good health requiring single-tooth implants with significant buccal ridge loss.
Not a fit: Patients with systemic health issues or those under treatments that compromise wound healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve bone regeneration techniques, leading to better outcomes for patients receiving dental implants.
How similar studies have performed: Previous studies have shown promising results with similar bone grafting techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: ≥ 18 years. * Good general health. * Single-tooth implant treatment. Presence of adjacent teeth and opposing occluding teeth (for measurement stent indexing). * Incisors, canines and premolars. * Presence of three intact socket walls after tooth extraction with a defect of more than 50% loss of the buccal ridge wall and no fragment of root should be left. * Reasons for tooth extraction: carious lesion, endodontic complication, root fracture and prosthetic reason. * Good oral and periodontal health. * Full-mouth plaque and bleeding \< 20%. * Able and willing to follow study procedures and instructions. * Informed consent. Exclusion Criteria: * ≤ 18 years. * Comprised health. Existence of any systemic condition such as uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, intravenous and oral bisphosphonate therapy, bone metabolic diseases, history of irradiation of the head and neck area, or any other immunosuppressive therapy that would contraindicate oral surgical treatment. * Absence of any adjacent teeth or the opposing occluding teeth. * Molars. * More than one bone wall defect. * Sinus pathology. * Allergy or hypersensitivity to medications or any of the products used throughout the study. * Heavy smokers (defined as \>10 cigarettes per day or \>1 cigar per day) or chew tobacco, including within 3 months prior to enrollment. * Untreated periodontitis. * Periapical or periodontal infection. * Full-mouth plaque and bleeding \> 20%. * No informed consent
Where this trial is running
Granada
- Dental School — Granada, Spain (Recruiting)
Study contacts
- Principal investigator: Manuel Toledano, Professor — Universidad de Granada
- Study coordinator: Manuel Toledano, Professor
- Email: toledano@ugr.es
- Phone: 34 958 243788
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.