Comparing two types of dental implants for immediate placement
Immediate Implant Using an Inverted Co-Axis at 12º Versus a Conventional Conical Implant: A Randomised Clinical Trial With 1 Year Follow-up
This study is testing whether a new type of dental implant works better than a traditional one for immediate placement in the front of the mouth, to see which one gives better results and looks nicer over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitat Internacional de Catalunya Academic / other |
| Locations | 1 site (Sant Cugat Del Vallès, Barcelona) |
| Trial ID | NCT06059105 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of an innovative Inverted Co-Axis implant with a 12º angled platform compared to a conventional conical implant for immediate placement in the maxillary anterior region. Patients will receive immediate implants along with provisional crowns, and the study will assess success rates, primary stability, and marginal bone loss over a one-year follow-up period. The trial involves random assignment of participants to either implant type, with a focus on achieving optimal prosthetic emergence and aesthetic outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with a single maxillary tooth requiring extraction and sufficient bone for implant placement.
Not a fit: Patients with contraindications for oral surgery or those with significant bone loss or soft tissue recession may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the success rates and aesthetic outcomes of immediate dental implants for patients with maxillary anterior tooth loss.
How similar studies have performed: While the specific design of the Inverted Co-Axis implant is novel, similar studies on immediate implants have shown promising results in improving outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who presented with a good well-being status and no contraindication for undergoing an oral surgical procedure * Patients aged 18 and over * Adequate oral hygiene, with patient's presenting a plaque index lower than 15% using the Index Scale publish by Löe et al. * Patients who demonstrated motivation and compiled by attending the allocated follow-up appointments * One single tooth indicated to be extracted due to having a poor prognosis in the maxilla (central or lateral incisors, canines or premolars) * Absence of vestibular dehiscence in the bone table and presence of soft tissue without recession (Alveolus type I according to the classification of Elian et al. which could be determined on the day of surgery * Sufficient bone to allow implant placement with primary stability * To avoid image blurring or artefacts during CBCT, patients were included if they did not have a bridge or amalgam restoration close to the implant placement. Exclusion Criteria: * If the patient presented with an acute infection in the tooth where the implant is to be placed * Absence of posterior sector in which it would cause an occlusal overload * Alveolus with enough space to place an implant with a diameter of 4.5mm (since implants with a 3.5 coronal diameter have a widening in the middle third of the implant of 4.5mm) * Patients with an unstable periodontal status * Patients who smoked more than 10 cigarettes a day * Patients who had medical histories which contraindicate implant surgery.
Where this trial is running
Sant Cugat Del Vallès, Barcelona
- Universitat Internacional de Catalunya — Sant Cugat Del Vallès, Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Andrea Galve
- Email: andreagalve@UIC.es
- Phone: +34659051487
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.