Implant Crown Design for Gum Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Dental implant crown delivered

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

Compensation: Varies

Number of Visits: 6

Duration: Immediate upon crown delivery

30 Participants Needed

Trial Summary

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

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Implant Crown Delivery for gum disease?

Research shows that using implants and double-crown prosthetic support can lead to successful long-term outcomes in patients with severe gum disease. Additionally, implant therapy has been effective in patients with aggressive gum disease, suggesting that similar treatments can be beneficial. ^{1 2 3 4 5}

Is the Implant Crown Design treatment generally safe for humans?

Research shows that dental implants, including those used for crowns, have been studied for safety and effectiveness. A study involving 700 patients over 5 years found that implant-supported prostheses were successful in at least 90% of cases, with complications and adverse responses being thoroughly evaluated. ^{4 6 7 8 9}

How is the Implant Crown Delivery treatment for gum disease different from other treatments?

The Implant Crown Delivery treatment is unique because it uses custom-designed ceramic abutments created with CAD/CAM technology, which allows for precise and aesthetic integration with the surrounding gum tissue. This approach is particularly beneficial for patients with severe periodontal disease, as it combines implants with double-crown prosthetic support to maintain soft-tissue contour and stability. ^{1 10 11 12 13}

What is the purpose of this trial?

This study will evaluate how the crown's shape under the gums will influence the gum tissue around dental implants.

Research Team

Muhammad Saleh, BDS, MSD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals with gum or periodontal disease who are receiving dental implants. Specific eligibility criteria have not been provided, so it's important to contact the study organizers for detailed requirements.

Inclusion Criteria

Be a current participant of HUM00208140 main study

My dental implant, placed over 3 months ago, is ready for its final restoration.

Exclusion Criteria

The dental implant crown was already delivered.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dental implants with either a straight or concave transmucosal contour

Immediate upon crown delivery

Follow-up

Participants are monitored for soft and hard tissue clinical outcomes after crown delivery

12 months

Regular visits at 6 months and 12 months

Treatment Details

Interventions

• Implant Crown Delivery

Trial Overview The study focuses on how different shapes of the part of a dental implant crown that sits under the gums affect the surrounding soft and hard tissues in patients with gum diseases.

Participant Groups

Group I: Straight transmucosal contour Active Control 1 Intervention

Implant crown will be designed with a straight transmucosal contour

Group II: Concave transmucosal contour Active Control 1 Intervention

Implant crown will be designed with a concave transmucosal contour

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

References

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

Prosthodontic Treatment Outcomes in Periodontally Compromised Patients: A 6- to 20-Year Long-Term Cohort Study. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Outcomes of implant therapy in patients with a history of aggressive periodontitis. A systematic review and meta-analysis. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Clinical assessment of different implant-supported esthetic crown systems fabricated with semi-digital workflow: Two-year prospective study. [2022]

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

The Influence of Crown-to-Implant Ratio on Crestal Bone Loss at Implants with Single Crowns and Bridges. [2023]

5. China pubmed.ncbi.nlm.nih.gov

[Research on gingival healing situation after stage II surgery of dental implantation for periodontitis patients]. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a novel dental implant system as single implants under immediate loading conditions - 4-month post-loading results from a multicentre randomised controlled trial. [2021]

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

The influence of implant design, application, and site on clinical performance and crestal bone: a multicenter, multidisciplinary clinical study. Dental Implant Clinical Research Group (Planning Committee). [2019]

8. Denmark pubmed.ncbi.nlm.nih.gov

Five-year retrospective study on success, survival and incidence of complications of single crowns supported by dental implants. [2022]

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

Clinical trials on placement of implants in existing bone. [2019]

10. Romania pubmed.ncbi.nlm.nih.gov

Biologic and Esthetic Outcome of CAD/CAM Custom Ceramic Implant Abutment: A Clinical Report. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

Complex fixed implant-supported restoration in a site compromised by periodontitis: a case report. [2021]

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

Replacing Hopeless Maxillary Incisors With Adjacent Implants via an Integrative Biologically Oriented Approach. [2019]

13. Denmark pubmed.ncbi.nlm.nih.gov

Association between periodontitis treatment outcomes and peri-implantitis: A long-term retrospective cohort study. [2021]