Impact of Implant Shape on Gum Health Around Dental Implants
Lnfluence of the Prosthetic Emergence Profile on the Prevalence of Peri-implant Diseases: a Cross Sectional Study
This study is testing how different shapes of dental implants affect gum health in patients who have had their implants for over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Universitat Internacional de Catalunya Academic / other |
| Locations | 1 site (Sant Cugat del Vallès, Barcelona) |
| Trial ID | NCT05592314 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate how the shape and contour of implant-supported restorations affect the health of soft and hard tissues around dental implants. A total of 120 patients will undergo a clinical and radiographic evaluation, including a digital scan of their crowns using an intraoral scanner. Participants will also complete a questionnaire regarding their dental care routines. The study focuses on patients who have had their implants loaded for over three years and are receiving maintenance therapy.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-80 with properly positioned dental implants that have been loaded for more than three years.
Not a fit: Patients with uncontrolled systemic diseases, pregnant or lactating women, and heavy smokers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved design and maintenance of dental implants, reducing the prevalence of peri-implant diseases.
How similar studies have performed: While the specific approach of this study is novel, similar studies have indicated that implant design can influence peri-implant health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18-80 years, * Implant properly positioned (≥ 2 mm from the buccal plate and \>1 mm from the lingual plate or in the ideal occlusal plane horizontally, 5 to 2 mm from the adjacent CEJ or from 2 mm below the residual ridge to crestal position (0 mm) apico-coronally and with an angulation of 70 to 90 degrees from the adjacent tooth long axis or from the ridge parallelism) (21), * Implant loading for more than 3 years, * Partial or total edentulism being restored with dental implants in the molar and premolar region with single or partial restorations. * Patients who have not taken any antibiotic and regular NSAIDs in the last 2 months prior to the clinical examination, Exclusion Criteria: * Uncontrolled systemic diseases (i.e., diabetes mellitus) * Pregnancy or lactation patients, * Smokers of ≥10 cig/day. * Zygomatic or pterygoid implants, * Removable prostheses and cement-retained implant prostheses, * Patients who have undergone non-surgical peri-implant treatment with prosthesis modifications, peri-implantitis surgical treatment or soft tissue augmentation procedures at the implant site. * Intake of medications known to modify bone metabolism (i.e., hyperparathyroidism, osteoporosis, and vitamin D deficiency), * Uncontrolled or active periodontal disease that required treatment.
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: Leire Izaskun, DDS
- Email: leiizas@uic.es
- Phone: 628362896
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.