Recruiting

Ceramic Implants

Sponsor:

CeraRoot SL

Code:

NCT06287346

Conditions

Edentulism

Tooth Loss

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

dental implant

Study Details

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.

Conditions

Edentulism

Tooth Loss

Study ID

NCT06287346

Start date

Jan 1, 2024

Status verified date

Feb, 2024

Completion date

Jan 1, 2030

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

652 participants

Anticipated

Interventions and Outcome Measures

Arms

One-piece

One-piece CeraRoot dental implants

Two-piece (TL)

Two-piece CeraRoot TL dental implants

Interventions

dental implant

ceramic dental implant

Primary outcome measure

  • Survival rate [ Time Frame: From enrolment to the end of treatment 12 months or more. ]

Central Contacts and Locations

Central contacts

Locations

Family Holistic Dentistry

Recruiting

Boulder, Colorado, United States, 80303

Contacts

Principal Investigator:

CARMEN BURKE, DDS

More Information

Sponsor

CeraRoot SL

Last update posted

Mar 1, 2024

Last verified

Feb, 2024

Keywords

  • dental implant
  • ceramic dental implant
  • zirconia implant
  • y-tzp
  • metal-free

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CeraRoot SL on 2024-03-01.