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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the shape of a dental implant crown affects the surrounding gum tissue. Researchers are testing two designs: one with a straight shape under the gums and another with a concave shape. They aim to determine which design promotes better gum healing around implants. Suitable participants have a dental implant ready for a crown and have participated in another related study. This trial offers a chance to contribute to improved dental care for those with gum disease. As an unphased trial, it provides a unique opportunity to directly impact future dental treatments and improve outcomes for others with similar conditions.

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 prior data suggests that this implant crown design is safe for gum disease?

Research has shown that implant-supported crowns, like those in this study, succeed in at least 90% of cases over five years, indicating that most people do not experience major problems. Studies on straight crowns that pass through the gum demonstrate their effectiveness, with few issues reported.

For both straight and slightly curved crowns that pass through the gum, evidence suggests they are well-tolerated, with few side effects. These findings come from studies involving many patients over several years, suggesting that the crowns under study are likely safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the implant crown designs being tested for gum disease because they offer new ways to enhance gum health and implant stability. Unlike traditional crown designs, these crowns use either a straight or concave transmucosal contour. The straight contour aims to provide a more natural fit, potentially reducing irritation, while the concave contour is designed to improve gum tissue integration, which could enhance healing and reduce the risk of infections. This approach might lead to better long-term outcomes for patients with gum disease, improving the success rates of dental implants.

What evidence suggests that this trial's implant crown designs could be effective for gum disease?

Research shows that the design of implant crowns significantly affects gum health around dental implants. Studies indicate that implant-supported crowns succeed at least 90% of the time. The shape of the crown where it meets the gums, known as the transmucosal contour, is crucial to this success. A review of studies found that different crown designs influence the health of the bone around the implant, which is vital for the implant's overall health. This trial will compare two designs: one group will receive crowns with a straight transmucosal contour, while another group will receive crowns with a concave transmucosal contour. Early results suggest that both straight and curved crown designs perform well, but ongoing research seeks to determine which design better supports healthy gums. ^{2 3 4 6 7}

Who Is on the Research Team?

Muhammad Saleh, BDS, MSD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

withpower.com

withpower.com/trial/phase-gingival-diseases-11-2023-4de45

Implant Crown Design for Gum Disease · Info for Participants

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 ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06185075?cond=Gum&lastUpdPost=2020-02-06_&viewType=Table&rank=5

Influence of Implant Crown Transmucosal Contour Design ...

An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3.

aging.networkofcare.org

aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06185075?keyword=%22Gum%20Disease%22

Influence of Implant Crown Transmucosal Contour Design ...

This research is studying the transmucosal contour, or shape of crowns (white-colored tooth structure that sits above the gum) under the gums on dental ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12273757/

The influence of prosthetic designs on peri‐implant bone loss

Implant prosthetic design significantly impacts peri‐implant health. This systematic review and meta‐analysis explored emerging concepts in prosthetic ...

5.

bmcoralhealth.biomedcentral.com

bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-024-05417-w

Peri-implant soft tissue conditioning of immediate posterior ...

At base line (1 week after crown delivery) as well as after 12 months, SSA group showed statistically significantly higher gum appearance score ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06185075

Influence of Implant Crown Transmucosal Contour Design ...

Study Overview. This study will evaluate how the crown's shape under the gums will influence the gum tissue around dental implants. This research is studying ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11891029/

Effect of CAD/CAM Abutment Morphology on the Outcomes ...

Variations in transmucosal abutment contour design may affect the outcomes of implant therapy. This randomized controlled trial was primarily ...