Conometric Dental Restoration for Tooth Loss

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to attach dental crowns without cement or screws. It focuses on the Acuris conometric concept, which uses friction to secure the crown. This technique suits individuals needing a single tooth implant in specific mouth areas, especially near a natural tooth or implant-supported restoration. Those who have lost a tooth and meet these conditions might be suitable for the trial. The researchers aim to evaluate the method's effectiveness over a year. As an unphased trial, participants contribute to pioneering research that may provide an innovative solution for dental restorations.

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.

What prior data suggests that the Acuris conometric concept is safe for dental restoration?

Research has shown that the Acuris conometric concept for dental restoration is designed to be safe and easy to tolerate. This method uses friction instead of cement or screws to secure the crown, reducing the risk of issues like cement leakage that can harm nearby tissues.

In earlier studies, patients using the Acuris method did not report major side effects. The technique aims to minimize problems like plaque buildup, which can lead to infections or bone loss. Although detailed safety data in humans is limited, the innovative design suggests a lower risk of common dental restoration issues.

The trial is labeled "Not Applicable" in phase, as it evaluates the concept itself rather than drug safety. However, using a mechanical approach without chemicals may lower the risk of serious reactions, making it a potentially safe option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Acuris conometric concept is unique because it offers a non-cemented solution for single tooth restorations, which makes it different from traditional dental implants that typically rely on cement or screws. This approach is exciting because it simplifies the restoration process, allowing for easier maintenance and potentially reducing complications often associated with cement use, like inflammation or loosening. Researchers are particularly interested in how this technique could improve long-term outcomes and comfort for patients experiencing tooth loss.

What evidence suggests that the Acuris conometric concept is effective for tooth loss?

Studies have shown that the Acuris conometric concept, tested in this trial for single tooth restorations, is promising for replacing a single tooth. It uses a special friction-based system to fit crowns, eliminating the need for cement or screws. This design speeds up crown placement and reduces the risk of complications. Research indicates that the conometric connection is very stable, securing the implant and its connecting part to the crown. This results in a more reliable and longer-lasting dental restoration. Overall, early findings suggest that Acuris could be an effective option for those needing single tooth replacements. ^{1 2 3 6 7}

Who Is on the Research Team?

Marco Degidi, Dr.

Principal Investigator

Degidi Dental Clinic, Bologna, Italy

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04063878

NCT04063878 | A Clinical Study on Acuris™ - Conometric ... 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 ...

2. withpower.com withpower.com/trial/phase-jaw-edentulous-6-2019-6c9a0

Conometric Dental Restoration for Tooth Loss The purpose of this study is to evaluate the outcome of prosthetic survival of the Acuris conometric concept 1 year after permanent restoration, ...

3. dentsplysirona.com dentsplysirona.com/content/dam/flagship/en/explore/implantology/treatment-concepts/acuris/documents/IMP-Acuris-Retention-redefined-brochure-32671573-USX-1807.pdf

Acuris™ –conometric concept - Retention redefined With Acuris, placing the final crown takes seconds rather than minutes. There is less risk of failure or biological complications too.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/78/NCT04063878/Prot_SAP_000.pdf

Clinical Investigation Plan Study code: C-OT-17-003. Study title: A prospective, multicenter study on Acuris™ - conometric concept for single tooth restoration. A 5-year follow-up study.

5. researchgate.net researchgate.net/publication/353693093_Evaluation_Of_The_Clinical_Effectiveness_Of_The_Conometric_Concept_-_A_Systematic_Review

Evaluation Of The Clinical Effectiveness Of The Conometric ... 73, 74 The conometric connection provides enhanced mechanical stability between the implant and abutment, thereby decreasing the likelihood of ...

6. researchgate.net researchgate.net/publication/362744759_The_Conometric_Connection_for_the_Implant-Supported_Fixed_Prosthesis_A_Narrative_Review

The Conometric Connection for the Implant-Supported ... Plaque accumulation, overloading, and periodontal infections were blamed for late bone loss [1].The Acuris-Conometric concept is a ...

7. dentsplysirona.com dentsplysirona.com/en-us/company/news-and-press-release-detail-page.html/content/dam/master/news/en/business-units/implants/2019/delivering-innovations-and-solutions--around-proven--documented-

Delivering innovations and solutions around proven ... ... results for patients. Acuris is based on a conometric concept that uses friction instead of a screw or cement to secure the crown and the cap to the ...