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Customized vs Standard Healing Abutments for Dental Implants
N/A
Recruiting
Research Sponsored by East Carolina University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months after crown delivery
Awards & highlights
Study Summary
This trial will compare the effects of using customized CAD/CAM healing abutments vs. standard healing abutments on dental implant success, patient satisfaction, and peri-implant health.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed for this type of dental procedure in the provided information, common issues might include discomfort at the implant site, swelling, bruising of gums/skin around the implant area and potential minor bleeding post-procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months after crown delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after crown delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical measurements around implants: Bleeding on probing (BOP)
Clinical measurements around implants: Gingival Index (GI)
Clinical measurements around implants: Plaque index (PI)
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Customized Healing AbutmentsExperimental Treatment2 Interventions
Placement of a customized CAD/CAM healing abutment after implant placement.
Group II: Stock Healing AbutmentsActive Control2 Interventions
Placement of a stock healing abutment after implant placement.
Find a Location
Who is running the clinical trial?
East Carolina UniversityLead Sponsor
107 Previous Clinical Trials
38,779 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You use illegal drugs.You possess neighboring teeth (mesial and distal).No further bone grafting or tissue enhancement is required.You are taking medications that can slow down bone healing.You have received chemotherapy treatment in the past 4 years.You are pregnant.You smoke more than 10 cigarettes a day currently.You have received radiation therapy to your head or neck in the past.You drink too much alcohol regularly, which means more than 4 drinks per day or 14 drinks per week for men and more than 3 drinks per day or 7 drinks per week for women.You have enough bone density for regular-sized implants.You are lacking a maxillary or mandibular molar that can be substituted with a dental implant.
Research Study Groups:
This trial has the following groups:- Group 1: Customized Healing Abutments
- Group 2: Stock Healing Abutments
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current opportunities to join this clinical trial?
"Affirmative. The information accessible through clinicaltrials.gov suggests that recruitment for this experiment is ongoing since its posting on September 1st 2022, and most recently edited March 13th 2023. 30 individuals are needed to be recruited at one medical centre."
Answered by AI
To what maximum capacity has this research been conducted?
"Correct. The information shared on clinicaltrials.gov indicates that this trial is actively recruiting subjects, with the initial posting having been published in September 1st 2022 and an update made March 13th 2023. 30 individuals are required to be enrolled at a single site."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
California
What site did they apply to?
East Carolina University School of Dental Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
0
Why did patients apply to this trial?
I am missing several teeth and i am disabled and my only health insurance is Texas Medicaid and that doesn't cover dental implants so I am looking for a trial that can help me replace even one of the teeth that I am missing.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How will Screening be done to see if I am an ideal candidate for this trial?
PatientReceived 2+ prior treatments
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