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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
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.
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Who is running the clinical trial?
East Carolina UniversityLead Sponsor
108 Previous Clinical Trials
38,717 Total Patients Enrolled
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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.
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