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

Tooth Loss Clinical Trial

— 240101  

Official title:

5-Years Multicentric Prospective Post-Market Clinical Follow-up (PMCF) Comparative Study of CeraRoot Ceramic Dental Implants One-piece Versus Two-piece.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06287346
• Other study ID #: 240101
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: January 1, 2030

Study information

• Verified date: February 2024
• Source: CeraRoot SL
• Contact: JOSEP Oliva, Dentist, DDS MSC
• Phone: 800-485-1613
• Email: josep.oliva[@]cerarootclinic.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 652
• Est. completion date: January 1, 2030
• Est. primary completion date: January 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edentulism
• Tooth Loss

Intervention

Device:
• dental implant
ceramic dental implant

Locations

Country	Name	City	State
Spain	CeraRoot CLINIC	Les Franqueses del Vallès	Barcelona
United States	Family Holistic Dentistry	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
CeraRoot SL

Countries where clinical trial is conducted

United States,  Spain, 

References & Publications (1)

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	The implant is osseointegrated and in function in the patient's jaw without pain and no mobility.	From enrolment to the end of treatment 12 months or more.
Secondary	Complications	Implantitis, mucositis, pain, implant fracture, prosthetic fracture, bone loss,	1 year after treatment