Using custom healing abutments for immediate dental implants
Dimensional Changes of Peri-implant Tissue in Immediate Implants With Individualized Healing Abutments Using a CAD/CAM Technique: Randomized Controlled Clinical Trial
NA · Universitat Internacional de Catalunya · NCT06455436
This study is testing if custom-made healing abutments can better protect the gums and bone around immediate dental implants than standard ones.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 25 Years and up |
| Sex | All |
| Sponsor | Universitat Internacional de Catalunya (other) |
| Locations | 1 site (Barcelona, Catalonia) |
| Trial ID | NCT06455436 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of custom healing abutments made with CAD/CAM technology in maintaining the stability of peri-implant tissues compared to standard healing abutments in immediate dental implants. After tooth extraction, participants will receive an immediate implant filled with a bone substitute and will be randomly assigned to either the control group with standard abutments or the test group with custom abutments. The goal is to determine if the custom abutments can better preserve the dimensions of the surrounding tissues during the healing process.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 and older who require extraction of a molar or premolar tooth and meet specific criteria regarding gum and bone health.
Not a fit: Patients with significant gum dehiscence, active infections, or insufficient bone structure for implant placement may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved healing outcomes and reduced complications for patients receiving immediate dental implants.
How similar studies have performed: While the use of immediate implants is established, the specific application of CAD/CAM custom healing abutments is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient ( 25 years old). * Need for extraction of an irrational tooth to be treated in the molar/premolar position of the upper/lower arch. * Presence of 2mm of keratinized gingiva. * Bone dehiscence in the alveolar walls of 2 mm. 2 mm. * Adequate amount of bone in the interradicular septum to stabilize the implant (minimum height 10 mm, minimum width 4 mm at the base of the septum). * Plaque index (FMSPI, full mouth score plaque index) \< 10%. * Non-smokers or smokers of less than 10 cigarettes per day. * Absence of systemic diseases that contraindicate implant surgery. Exclusion Criteria: * Presence of alveoli with dehiscence \>2mm. * Presence of adjacent implants. * \< 2mm of keratinized gingiva. * Presence of active infection (fistula, suppuration) at the extraction site. * Presence of apical granuloma \>2mm in diameter in the root(s) of the tooth or teeth to be extracted. * Residual bone apical to the extraction insufficient to anchor the implant. * Pregnant or lactating women. * Severe cognitive or psychiatric disorders. * Compromised general health status ( ASA IV). * Use of drugs that alter bone metabolism and healing. * Absence of manual primary stability of the implant * Bone dehiscence or fenestration after implant placement (manual rotation). * Gap 2mm between the implant and the vestibular bone wall.
Where this trial is running
Barcelona, Catalonia
- Universitat Internacional de Catalunya — Barcelona, Catalonia, Spain (RECRUITING)
Study contacts
- Principal investigator: Matteo Albertini, PhD — Universidad Internacional de Catalunya
- Study coordinator: Javi Vilarrasa, MSc
- Email: jvilarrasa@uic.es
- Phone: +34 628553000
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.
Conditions: Dental Implant, Immediate Dental Implant, Wound Heal, implant, soft tissue