Customized vs Standard Healing Abutments for Dental Implants

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: East Carolina University

Must not be taking: Bisphosphonates, RANKL inhibitors, PPIs

Disqualifiers: Active periodontal disease, Caries, Smoking, Diabetes, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether customized healing abutments (connectors that help gums heal around dental implants) are more effective than standard ones after dental implant surgery. The researchers aim to determine if personalized abutments improve gum and bone health, as well as the overall appearance and function of the implant. Participants will also report their satisfaction levels regarding comfort and appearance. This trial is for individuals needing a single dental implant for a missing molar and who have sufficient bone and neighboring teeth to support it. As an unphased trial, it offers participants the chance to contribute to innovative dental research that could enhance future implant procedures.

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

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications that can impair bone healing, like bisphosphonates, RANKL inhibitors, or proton pump inhibitors.

What prior data suggests that these healing abutments are safe for dental implants?

Research has shown that custom-made healing caps used after dental implants are generally well-accepted by patients. One study found that these custom caps lead to better bone and tissue health compared to regular ones. Patients reported no major side effects, indicating safety. Another study found that custom titanium caps put less stress on the bone, which supports their safety. Additionally, materials like PEEK used in these caps may benefit the soft tissues around the implant. Overall, studies suggest that custom healing caps are safe with few reported problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of customized healing abutments for dental implants because they offer a tailored fit using advanced CAD/CAM technology. Unlike standard stock abutments, which are one-size-fits-all, customized abutments are designed specifically for each patient's unique dental anatomy. This personalized approach could improve healing outcomes and enhance the overall success of dental implants by better supporting the surrounding gum tissue and promoting optimal healing conditions.

What evidence suggests that customized CAD/CAM healing abutments are effective for dental implants?

This trial will compare customized CAD/CAM healing abutments with standard stock healing abutments for dental implants. Research has shown that custom-made healing caps can lead to better results. These custom caps help maintain the stability of surrounding gums and bone, which is crucial for the implant's long-term success. They also tend to look more natural than standard options. Additionally, custom caps have been linked to better control of plaque and bleeding, which are important for maintaining a healthy area. Overall, evidence suggests that custom caps could provide a more stable and attractive outcome. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are missing a molar tooth that can be replaced with an implant, have adjacent teeth on both sides, and enough bone volume without needing extra grafting. It's not for those with less than 3mm of gum tissue at the site, drug or heavy alcohol use, uncontrolled diabetes, recent chemotherapy or radiation in head/neck area, pregnant women, or heavy smokers.

Inclusion Criteria

You possess neighboring teeth (mesial and distal).

No further bone grafting or tissue enhancement is required.

You have enough bone density for regular-sized implants.

Exclusion Criteria

<3mm of keratinized tissue at implant site

You use illegal drugs.

Presence of caries or periapical pathology in adjacent teeth

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Placement of either standard or customized CAD/CAM healing abutments after implant placement

6 months

Visits at crown delivery, 3 months, and 6 months

Follow-up

Participants are monitored for soft and hard tissue changes, clinical measurements, and patient satisfaction

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Placement of customized CAD/CAM healing abutment
• Placement of dental implant
• Placement of stock healing abutment

Trial Overview

The study tests if customized CAD/CAM healing abutments improve soft and hard tissue stability around dental implants compared to standard ones. Participants will receive either the custom-made or standard abutment randomly and will be monitored for six months after getting their implant crowns.

How Is the Trial Designed?

Group I: Customized Healing Abutments Experimental Treatment 2 Interventions

Placement of a customized CAD/CAM healing abutment after implant placement.

Group II: Stock Healing Abutments Active Control 2 Interventions

Placement of a stock healing abutment after implant placement.

Who Is Running the Clinical Trial?

East Carolina University

Lead Sponsor

Trials

111

Recruited

42,400+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12419190/

Effectiveness of customized healing abutments in ...

This study evaluated the influence of a customized healing abutment (CHA) placed on immediate implants. It also assessed bone ridge volume, ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S002239132500770X

Systematic Review Clinical outcome of custom healing ...

Custom healing abutments have been claimed to provide better esthetic and peri-implant hard and soft tissue outcomes after implant placement ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12385633/

Comparative Evaluation of Customized CAD/CAM vs. Stock ...

Many studies indicate that custom abutments yield superior soft tissue adaptation and esthetic outcomes compared to stock abutments. For example ...

4.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT05989061

PEEK Versus Titanium Customized Healing Abutments

The study suggests that if the investigators used customized healing abutments synthesized from PEEK may have a favorable effect on peri-implant soft ...

5.

mdpi.com

mdpi.com/2673-1592/6/3/42

Soft-Tissue Management Dental Implants with Digitally ...

This pilot study aimed to evaluate the effectiveness of digitally crafted customized healing abutments in stabilizing peri-implant soft tissues following tooth ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S002239132500770X?dgcid=rss_sd_all

Clinical outcome of custom healing abutments in ...

Custom healing abutments have been claimed to provide better esthetic and peri-implant hard and soft tissue outcomes after implant placement ...

7.

journalimplantdent.springeropen.com

journalimplantdent.springeropen.com/articles/10.1186/s40729-024-00581-8

Systematic review of peri-implant conditions and aesthetic ...

The aim of this study was to evaluate clinical differences between customized and conventional healing abutments in patients with dental ...