5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece.

Recruiting

• Conditions: Edentulism; Tooth Loss
• Interventions: Device: dental implant

• Registration Number: NCT06287346
• Lead Sponsor: CeraRoot SL

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.

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-02-29
• Last Update Submitted: 2024-02-29
• Study First Posted: 2024-03-01
• Last Update Posted: 2024-03-01
• Primary Completion: 2029-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 652

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Two-piece (TL)	dental implant	Two-piece CeraRoot TL dental implants
One-piece	dental implant	One-piece CeraRoot dental implants

Primary Outcome Measures

Name	Time	Method
Survival rate	From enrolment to the end of treatment 12 months or more.	The implant is osseointegrated and in function in the patient's jaw without pain and no mobility.

Secondary Outcome Measures

Name	Time	Method
Complications	1 year after treatment	Implantitis, mucositis, pain, implant fracture, prosthetic fracture, bone loss,

Trial Locations

Locations (2)

Family Holistic Dentistry; 🇺🇸 Boulder, Colorado, United States

CeraRoot CLINIC; 🇪🇸 Les Franqueses del Vallès, Barcelona, Spain