Clinical trial NCT06287346: 5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece.
Official title: 5-Years Multicentric Prospective Post-Market Clinical Follow-up (PMCF) Comparative Study of CeraRoot Ceramic Dental Implants One-piece Versus Two-piece.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Edentulism
Tooth Loss
Keywords: dental implant
ceramic dental implant
zirconia implant
y-tzp
metal-free
Lead sponsor: CeraRoot SL
Sponsor class: INDUSTRY
First posted: 2024-03-01
Enrollment: 652
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The geographic population of study will be the patients in two different private dental centers located in Barcelona (Spain) and Boulder (Colorado, USA).

Brief summary: The goal of this cohort observational study is to compare in the survival rate of ceramic dental implants placed in patients with missing or hopeless teeth . The main question\[s\] it aims to answer are:

* Are there any significant differences in survival rate between the use of one-piece ceramic implant versus the two-piece (TL) variant?
* What are the complications associated to the procedure and differences between the two groups.

Detailed description: The present clinical study protocol has the objective to compare the performance of different CeraRoot ceramic implant models (16,11,21,12,14,34,34L) and the different sub-variants (one-piece versus two-piece).

The geographic population of study will be the patients in two different dental centers located in Barcelona (Spain) and Boulder (Colorado, USA). The intended population as described in the device instruction for use (3) is " Intended Population: All fully-grown patients (men or women) requiring dental reconstruction using dental implants and who have no contraindications. The CeraRoot® dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of partial or total edentulism.
* Specially indicated for patients with metal allergies and chronic illness due to metal allergies.

Exclusion Criteria:

1. General Contraindications:

   1. Local and Systemic contraindications for surgery.
   2. Poor oral hygiene
   3. Patients with health problems, disease or any physical or psychological condition to which an oral surgery may be contraindicated.
2. Relative Contraindications:

   1. Previously irradiated bone
   2. diabetes
   3. anticoagulant medication
   4. hemodynamic problems
   5. bruxism
   6. Para functional habits
   7. bad bone anatomy
   8. smokers
   9. none controlled periodontitis
   10. malocclusions
   11. TMJ problems
   12. diseases in the oral cavity
   13. pregnancy
   14. insufficient oral hygiene for adequate health.
3. Local contraindications

   1. insufficient bone quantity or quality
   2. remaining of roots
   3. localized periodontal disease
   4. Any pathology in the neighboring teeth.

Primary outcomes:
measure: Survival rate
timeFrame: From enrolment to the end of treatment 12 months or more.
Secondary outcomes:
measure: Complications
timeFrame: 1 year after treatment
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Family Holistic Dentistry
state: Colorado
city: Les Franqueses del Vallès
country: Spain
facility: CeraRoot CLINIC
state: Barcelona
Study officials:
References:
citation: undefined