Impact of Abutment Design on Tissue Around Dental Implants
Effect of Abutment 3-dimensional Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial
NA · Semmelweis University · NCT06407271
This study tests how different designs of dental abutments affect the healing and appearance of the gums and bone around dental implants for people with a missing tooth in the front of their mouth.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Semmelweis University (other) |
| Locations | 1 site (Budapest, Pest County) |
| Trial ID | NCT06407271 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of different abutment configurations on the hard and soft tissue around dental implants placed in the aesthetic zone of the maxilla. Patients with a single missing tooth will receive either custom or cylindrical healing abutments, followed by screw-retained ceramic crowns. The study will measure tissue volume changes, keratinized mucosa thickness, and blood flow during the healing process. Outcomes will be assessed using aesthetic scores and monitoring for complications over a three-year period.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a single missing tooth in the maxillary anterior region and a thick phenotype.
Not a fit: Patients with general health issues, active periodontal disease, or those who smoke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the aesthetic outcomes and tissue health around dental implants, leading to improved patient satisfaction.
How similar studies have performed: Previous studies have shown promising results with custom abutment designs, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients over 18 years * good general health * good oral hygiene (FMPS \< 25%) * healthy periodontium (PPD \< 4mm) * thick phenotype * maxilla anterior region (extended to 15-25 positions) * solo missing teeth, intact adjacent teeth * type 1 alveolar shape after extraction 1 * retained occlusion * baseline buccal bone wall thickness at least 1.5 mm, based on intact CBCT scan * patient voluntarily accepts and signs the information and consent form for the study Exclusion Criteria: * general ill health * general surgical or oral surgery contraindication * a patient who has undergone local radiotherapy * active periodontal inflammation, inflammation of the alveolar cavity * smoking * posterior region * pregnancy, lactation * psychological or mental involvement affecting individual plaque control * presence of an implant adjacent to the planned implant * inadequate oral hygiene * need for vertical bone augmentation * gingival recession * Inappropriate implant position for screw fixation * bruxism
Where this trial is running
Budapest, Pest County
- Semmelweis University, Department of Prosthodontics — Budapest, Pest County, Hungary (RECRUITING)
Study contacts
- Principal investigator: Krisztina Mikulás, PhD — Semmelweis University, Department of Prosthodontics
- Study coordinator: Krisztina Mikulás, PhD
- Email: mikulas.krisztina1@semmelweis.hu
- Phone: +36309365144
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 Implants, Single-Tooth, Dental Implant-Abutment Design, Peri-Implant Tissue Management, CAD-CAM