Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2022-09-01
2024-12-31
Brief Summary
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Aim 1 will measure soft and hard tissue changes around dental implants when customized CAD/CAM healing abutments are utilized as compared to standard healing abutments. Soft tissue stability will be measured utilizing intraoral digital scans, while osseous levels will be measured utilizing CBCT scans. Soft and hard tissue volumetric and linear changes will be measured by digital scan superimposition at the time of crown delivery and 6 months thereafter. Volumetric and linear changes will be compared within each group at different time points and between the test and control group to determine if the use of customized CAD/CAM healing abutments is advantageous in terms of maintaining peri-implant soft and hard tissue stability.
Aim 2 will assess different clinical measurements around dental implants to analyze if the use of customized CAD/CAM healing abutments will demonstrate improved plaque control and peri-implant health as compared to standard healing abutments. Plaque index (PI), gingival index (GI), probing depths (PD), and bleeding on probing (BOP) will be obtained at the time of crown delivery and at 3 and 6 months. Clinical measurements will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will aid in obtaining a natural looking restoration that would result in improved clinical parameters that measure peri-implant health.
Aim 3 will compare the degree of patient satisfaction using a visual analogue scale (VAS) in patients that received an implant restoration following the use of a customized CAD/CAM healing abutment as compared to standard healing abutments. Patients will complete a VAS questionnaire that will evaluate patient perception of pain, esthetics, ability to chew, and ability to clean. Scores will be compared among groups to evaluate if there is a difference in patient-centered outcomes when customized healing abutments are used as compared to standard healing abutments.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Customized Healing Abutments
Placement of a customized CAD/CAM healing abutment after implant placement.
Placement of dental implant
Placement of a dental implant on the edentulous ridge
Placement of customized CAD/CAM healing abutment
Placement of customized CAD/CAM healing abutment after implant has been placed on the edentulous ridge
Stock Healing Abutments
Placement of a stock healing abutment after implant placement.
Placement of dental implant
Placement of a dental implant on the edentulous ridge
Placement of stock healing abutment
Placement of stock healing abutment after implant has been placed on the edentulous ridge
Interventions
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Placement of dental implant
Placement of a dental implant on the edentulous ridge
Placement of stock healing abutment
Placement of stock healing abutment after implant has been placed on the edentulous ridge
Placement of customized CAD/CAM healing abutment
Placement of customized CAD/CAM healing abutment after implant has been placed on the edentulous ridge
Eligibility Criteria
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Inclusion Criteria
* Missing a maxillary or mandibular molar that can be replaced with a dental implant
* Sufficient bone volume for standard-sized implants
* Presence of adjacent teeth (mesial and distal)
* No requirement of additional osseous grafting or soft tissue augmentation
Exclusion Criteria
* Pregnant women
* Active periodontal disease
* Presence of caries or periapical pathology in adjacent teeth
* Use of medications that can impair osseous healing (bisphosphonates, RANKL inhibitors, proton pump inhibitors)
* Current smokers (\>10 cigarettes per day)
* Uncontrolled diabetes (HBA1c \>8)
* \<3mm of keratinized tissue at implant site
* History of head or neck radiation therapy
* History of chemotherapy within the last 4 years
* Uncontrolled alcohol use (more than 4 drinks on any day or more than 14 drinks per week for men and more than 3 drinks on any day or more than 7 drinks per week for women)
* Illicit drug use
18 Years
ALL
Yes
Sponsors
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East Carolina University
OTHER
Responsible Party
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Acela A. Martinez Luna
Clinical Associate Professor
Locations
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East Carolina University School of Dental Medicine
Greenville, North Carolina, United States
Countries
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Other Identifiers
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21-000291
Identifier Type: -
Identifier Source: org_study_id
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