Conometric Dental Restoration for Tooth Loss

Recruiting at 8 trial locations

Overseen By Lyndon Cooper, Prof. Dr.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dentsply Sirona Implants

Must not be taking: Corticosteroids, iv bisphosphonates

Disqualifiers: Uncontrolled diabetes, malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

160 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those taking medications that could affect healing or implant integration, like corticosteroids or certain bone medications.

Is Conometric Dental Restoration generally safe for humans?

Dental materials, including those used in Conometric Dental Restoration, are considered among the safest medical devices with very few reports of adverse reactions or injuries. This is due to strict regulations, responsible manufacturing, and clinical vigilance, which help ensure they do not pose a risk to patients. ^{1 2 3 4 5}

How does the Acuris treatment for tooth loss differ from other treatments?

Acuris is unique because it uses a conometric concept, which means it relies on friction retention rather than cement or screws to hold dental restorations in place, making the process simpler and potentially more comfortable for patients. ^{6 7 8 9 10}

What is the purpose of this trial?

The purpose of this study is to evaluate the outcome of prosthetic survival of the Acuris conometric concept 1 year after permanent restoration, since this is a new mode of retention using friction for seating the crown of single tooth restorations without using cement or screws.

Research Team

Marco Degidi, Dr.

Principal Investigator

Degidi Dental Clinic, Bologna, Italy

Eligibility Criteria

This trial is for adults aged 18-75 needing a dental implant in specific positions of the jaw, with adjacent teeth or implants. They must understand and consent to the study, be likely to have stable implant placement, and commit to follow-up visits for five years. Exclusions include major bone grafting needs, non-compliance risks, recent head/neck radiation therapy, uncontrolled oral diseases or diabetes, certain medication use that affects healing/osseointegration, heavy smoking (>10 cigarettes/day), and recent participation in conflicting studies.

Inclusion Criteria

You have a dental restoration (either natural or implanted) located towards the front of your mouth.

The investigator believes that your implant is stable and unlikely to cause any immediate problems.

I have at least one natural tooth or dental implant in the jaw opposite to where my new crown will be.

Exclusion Criteria

You currently have a problem with alcohol or drug abuse.

Severe non-compliance to CIP as judged by the Investigator and/or Dentsply Sirona Implants.

Involvement in the planning and conduct of the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Acuris conometric concept for single tooth restoration

1 year

Follow-up

Participants are monitored for prosthetic survival and other outcomes

5 years

Treatment Details

Interventions

• Acuris

Trial Overview The Acuris conometric concept is being tested for single tooth restoration without cement or screws. It uses friction to secure crowns on natural roots or implants. The study aims to assess how well these restorations survive after one year.

Participant Groups

Group I: Single tooth restorations using Acuris conometric concept Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Dentsply Sirona Implants

Lead Sponsor

Trials

63

Recruited

4,600+

Simon Campion

Dentsply Sirona Implants

Chief Executive Officer since 2022

PhD in Chemistry from Texas A&M University

Dr. David Ferguson

Dentsply Sirona Implants

Chief Medical Officer

MD from Harvard Medical School

Dentsply Sirona Implants and Consumables

Lead Sponsor

Trials

68

Recruited

4,800+

Simon Campion

Dentsply Sirona Implants and Consumables

Chief Executive Officer since 2022

PhD in Chemistry from Texas A&M University

Dr. Patrizia Cavazzoni

Dentsply Sirona Implants and Consumables

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

Out of 16,060 patients treated at the School of Dentistry, only 0.26% (43 patients) reported adverse events, highlighting that such incidents are relatively rare but still significant.

A striking 97.7% of these adverse events were deemed preventable, with the majority occurring during clinical treatments by postgraduate students, indicating a need for improved training and safety protocols in dental education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of the adverse events reported to the office of the clinical director at a dental school in Bogotá, Colombia. Huertas, MF., Gonzalez, J., Camacho, S., et al.[2018]

In a randomized trial involving 41 patients, the clinical performance of nanofill, a nanohybrid, and a microhybrid composite in posterior tooth restorations was evaluated over 12 months.

The study found that the materials used showed acceptable clinical performance after one year, suggesting they are a viable option for dental restorations, although further long-term evaluations are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of nanofill and nanohybrid composite in Class I restorations: a 12-month randomized trial. Andrade, AK., Duarte, RM., Silva, FD., et al.[2012]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Longevity of posterior composite restorations in children suffering from early childhood caries-results from a retrospective study. [2021]

2. Argentina pubmed.ncbi.nlm.nih.gov

Analysis of the adverse events reported to the office of the clinical director at a dental school in Bogotá, Colombia. [2018]

3. Denmark pubmed.ncbi.nlm.nih.gov

Reporting on adverse reactions to dental materials--intraoral observations at a clinical follow-up. [2019]

4. England pubmed.ncbi.nlm.nih.gov

The safety and biocompatibility of direct aesthetic restorative materials. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of nanofill and nanohybrid composite in Class I restorations: a 12-month randomized trial. [2012]

6. Brazil pubmed.ncbi.nlm.nih.gov

Influence of anatomic reference on the buccal contour of prosthetic crowns. [2019]

7. Singapore pubmed.ncbi.nlm.nih.gov

Esthetic recovery of smile using composite resin and "biological posts" and crowns. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Digital workflow to rehabilitate worn dentition on a non-hinge simulated patient. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Full-mouth rehabilitation in a completely digital workflow using partially adhesive monolithic zirconia restorations. [2023]

10. China pubmed.ncbi.nlm.nih.gov

[Clinical criteria for the assessment of dental restoration]. [2019]