Edentulous Alveolar RidgeNCT05769673
Soft and Hard Tissue Changes Around Implants
A study testing Placement of dental implant, Placement of stock healing abutment and Placement of customized CAD/CAM healing abutment in people with Edentulous Alveolar Ridge, run by East Carolina University at 1 site in United States.
Trial summary
Our long-term goal is to generate evidence for the creation of successful implant restorations and ideal supporting tissues in adequate health by utilizing patient-tailored implant protocols such as the use of customized computer-aided design and computer-aided manufacturing (CAD/CAM) healing abutments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- Placement of dental implant, Placement of stock healing abutment and Placement of customized CAD/CAM healing abutment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients >18 years
- 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
Who cannot join
- Patients <18 years
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University School of Dental Medicine
Greenville, North Carolina, 27834
About this study
Official title: Soft and Hard Tissue Changes Around Implants Using Customized CAD/CAM Healing Abutments
Our long-term goal is to generate evidence for the creation of successful implant restorations and ideal supporting tissues in adequate health by utilizing patient-tailored implant protocols such as the use of customized computer-aided design and computer-aided manufacturing (CAD/CAM) healing abutments. With this study, the investigators intend to recruit patients requiring a single implant placement and implant crown in molar areas. Patients will be randomly assigned to either the control group that will receive standard healing abutments or the test control group that will receive customized CAD/CAM healing abutments. Patients will be followed for six months after the delivery of the implant crowns. The central hypothesis is that the use of customized CAD/CAM healing abutments will demonstrate improved outcomes in terms of hard and soft tissue volume stability and clinical parameters as compared to the use of standard healing abutments.
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.
Read more
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.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- Placement of dental implant, Placement of stock healing abutment, Placement of customized CAD/CAM healing abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of dental implantProcedure or surgery
Placement of a dental implant on the edentulous ridge
Placement of stock healing abutmentProcedure or surgery
Placement of stock healing abutment after implant has been placed on the edentulous ridge
Placement of customized CAD/CAM healing abutmentProcedure or surgery
Placement of customized CAD/CAM healing abutment after implant has been placed on the edentulous ridge
| Study group | Role | What they receive |
|---|---|---|
| Customized Healing Abutments | Experimental | Placement of a customized CAD/CAM healing abutment after implant placement. Receives: Procedure: Placement of dental implant; Procedure: Placement of customized CAD/CAM healing abutment |
| Stock Healing Abutments | Active comparator | Placement of a stock healing abutment after implant placement. Receives: Procedure: Placement of dental implant; Procedure: Placement of stock healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear soft tissue changes around dental implants
Soft tissue linear changes will be measured by digital scan superimposition at the time of crown delivery and 6 months thereafter in millimeters. 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 minimizing changes.
Measured: baseline and 6 months after crown delivery
Volumetric soft tissue changes around dental implants
Soft tissue volumetric changes will be measured by digital scan superimposition at the time of crown delivery and 6 months thereafter in cubic millimeters. Volumetric 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 minimizing changes.
Measured: baseline and 6 months after crown delivery
Linear hard tissue changes around dental implants
Hard tissue (osseous) linear changes will be measured utilizing a STL file obtained from the CBCT scans. Hard tissue linear changes will be measured by digital superimposition at the time of crown delivery and 6 months thereafter in millimiters. 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 minimizing changes.
Measured: baseline and 6 months after crown delivery
Volumetric hard tissue changes around dental implants
Hard tissue (osseous) volumetric changes will be measured utilizing a STL file obtained from the CBCT scans. Hard tissue volumetric changes will be measured by digital superimposition at the time of crown delivery and 6 months thereafter in cubic millimiters. Volumetric 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 minimizing changes.
Measured: baseline and 6 months after crown delivery
Clinical measurements around implants: Plaque index (PI)
Plaque index (PI) will be recorded at six sites around the implant crown (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). Each site will be graded based on a scale from 0 to 3 and the sum of all sites will calculate the overall PI ranging from 0 to 18 (0 being the best outcome possible and 18 the worst outcome possible). Plaque scores will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Measured: baseline
Clinical measurements around implants: Plaque index (PI)
Plaque index (PI) will be recorded at six sites around the implant crown (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). Each site will be graded based on a scale from 0 to 3 and the sum of all sites will calculate the overall PI ranging from 0 to 18 (0 being the best outcome possible and 18 the worst outcome possible). Plaque scores will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Measured: 3 months after crown delivery
Clinical measurements around implants: Plaque index (PI)
Plaque index (PI) will be recorded at six sites around the implant crown (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). Each site will be graded based on a scale from 0 to 3 and the sum of all sites will calculate the overall PI ranging from 0 to 18 (0 being the best outcome possible and 18 the worst outcome possible). Plaque scores will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Measured: 6 months after crown delivery
Clinical measurements around implants: Gingival Index (GI)
Gingival index (GI) will be recorded at six sites around the implant crown (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). Each site will be graded based on a scale from 0 to 3 and the sum of all sites will calculate the overall GI ranging from 0 to 18 (0 being the best outcome possible and 18 the worst outcome possible). Gingival index scores will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Measured: baseline
Clinical measurements around implants: Gingival Index (GI)
Gingival index (GI) will be recorded at six sites around the implant crown (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). Each site will be graded based on a scale from 0 to 3 and the sum of all sites will calculate the overall GI ranging from 0 to 18 (0 being the best outcome possible and 18 the worst outcome possible). Gingival index scores will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Measured: 3 months after crown delivery
Clinical measurements around implants: Gingival Index (GI)
Gingival index (GI) will be recorded at six sites around the implant crown (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). Each site will be graded based on a scale from 0 to 3 and the sum of all sites will calculate the overall GI ranging from 0 to 18 (0 being the best outcome possible and 18 the worst outcome possible). Gingival index scores will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Measured: 6 months after crown delivery
Clinical measurements around implants: Probing depths (PD)
Probing depths (PD) will be recorded at six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) from the gingival margin to the base of the sulcus around the implant crown. Each site will be measured in millimeters. Probing depths will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Measured: baseline
Clinical measurements around implants: Probing depths (PD)
Probing depths (PD) will be recorded at six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) from the gingival margin to the base of the sulcus around the implant crown. Each site will be measured in millimeters. Probing depths will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Measured: 3 months after crown delivery
Clinical measurements around implants: Probing depths (PD)
Probing depths (PD) will be recorded at six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) from the gingival margin to the base of the sulcus around the implant crown. Each site will be measured in millimeters. Probing depths will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Measured: 6 months after crown delivery
Clinical measurements around implants: Bleeding on probing (BOP)
Bleeding on probing (BOP) will be recorded at six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) around the implant crown. BOP will be recorded as positive if it occurs within 30 seconds of probing and recorded as negative if it does not occur. BOP will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Measured: baseline
Clinical measurements around implants: Bleeding on probing (BOP)
Bleeding on probing (BOP) will be recorded at six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) around the implant crown. BOP will be recorded as positive if it occurs within 30 seconds of probing and recorded as negative if it does not occur. BOP will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Measured: 3 months after crown delivery
Clinical measurements around implants: Bleeding on probing (BOP)
Bleeding on probing (BOP) will be recorded at six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) around the implant crown. BOP will be recorded as positive if it occurs within 30 seconds of probing and recorded as negative if it does not occur. BOP will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Measured: 6 months after crown delivery
Degree of patient satisfaction
Patients will complete a visual analogue scale (VAS) questionnaire. On a scale from 0 to 10 (0 being the worst outcome possible and 10 the best outcome possible), patients will be asked their perception of pain during the procedure, 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.
Measured: 6 months after crown delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Sep 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Acela A. Martinez Luna, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769673
- Sponsor's protocol ID
- 21-000291
- Status last verified
- Aug 2024
- First submitted
- 25 Jan 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft and Hard Tissue Changes Around Implants Using Customized CAD/CAM Healing Abutments
- ClinicalTrials.gov ID
- NCT05769673
- Acronym / sponsor ID
- 21-000291
- Conditions
- Edentulous Alveolar Ridge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our long-term goal is to generate evidence for the creation of successful implant restorations and ideal supporting tissues in adequate health by utilizing patient-tailored implant protocols such as the use of customized computer-aided design and computer-aided manufacturing (CAD/CAM) healing abutments. With this study, the investigators intend to recruit patients requiring a single implant placement and implant crown in molar areas. Patients will be randomly assigned to either the control group that will receive standard healing abutments or the test control group that will receive customized CAD/CAM healing abutments. Patients will be followed for six months after the delivery of the implant crowns. The central hypothesis is that the use of customized CAD/CAM healing abutments will demonstrate improved outcomes in terms of hard and soft tissue volume stability and clinical parameters as compared to the use of standard healing abutments.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Customized Healing Abutments | Experimental | Procedure: Placement of dental implant, Procedure: Placement of customized CAD/CAM healing abutmentPlacement of a customized CAD/CAM healing abutment after implant placement. |
| Stock Healing Abutments | Active comparator | Procedure: Placement of dental implant, Procedure: Placement of stock healing abutmentPlacement of a stock healing abutment after implant placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients >18 years
- 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
Key exclusion criteria (12 listed)
- Patients <18 years
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placement of dental implantPlacement of a dental implant on the edentulous ridge | Procedure or surgery | Customized Healing Abutments, Stock Healing Abutments |
| Placement of stock healing abutmentPlacement of stock healing abutment after implant has been placed on the edentulous ridge | Procedure or surgery | Stock Healing Abutments |
| Placement of customized CAD/CAM healing abutmentPlacement of customized CAD/CAM healing abutment after implant has been placed on the edentulous ridge | Procedure or surgery | Customized Healing Abutments |
Primary outcome
Linear soft tissue changes around dental implants
Time frame: baseline and 6 months after crown delivery
Soft tissue linear changes will be measured by digital scan superimposition at the time of crown delivery and 6 months thereafter in millimeters. 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 minimizing changes.
Volumetric soft tissue changes around dental implants
Time frame: baseline and 6 months after crown delivery
Soft tissue volumetric changes will be measured by digital scan superimposition at the time of crown delivery and 6 months thereafter in cubic millimeters. Volumetric 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 minimizing changes.
Linear hard tissue changes around dental implants
Time frame: baseline and 6 months after crown delivery
Hard tissue (osseous) linear changes will be measured utilizing a STL file obtained from the CBCT scans. Hard tissue linear changes will be measured by digital superimposition at the time of crown delivery and 6 months thereafter in millimiters. 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 minimizing changes.
Volumetric hard tissue changes around dental implants
Time frame: baseline and 6 months after crown delivery
Hard tissue (osseous) volumetric changes will be measured utilizing a STL file obtained from the CBCT scans. Hard tissue volumetric changes will be measured by digital superimposition at the time of crown delivery and 6 months thereafter in cubic millimiters. Volumetric 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 minimizing changes.
Clinical measurements around implants: Plaque index (PI)
Time frame: baseline
Plaque index (PI) will be recorded at six sites around the implant crown (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). Each site will be graded based on a scale from 0 to 3 and the sum of all sites will calculate the overall PI ranging from 0 to 18 (0 being the best outcome possible and 18 the worst outcome possible). Plaque scores will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Clinical measurements around implants: Plaque index (PI)
Time frame: 3 months after crown delivery
Plaque index (PI) will be recorded at six sites around the implant crown (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). Each site will be graded based on a scale from 0 to 3 and the sum of all sites will calculate the overall PI ranging from 0 to 18 (0 being the best outcome possible and 18 the worst outcome possible). Plaque scores will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Clinical measurements around implants: Plaque index (PI)
Time frame: 6 months after crown delivery
Plaque index (PI) will be recorded at six sites around the implant crown (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). Each site will be graded based on a scale from 0 to 3 and the sum of all sites will calculate the overall PI ranging from 0 to 18 (0 being the best outcome possible and 18 the worst outcome possible). Plaque scores will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Clinical measurements around implants: Gingival Index (GI)
Time frame: baseline
Gingival index (GI) will be recorded at six sites around the implant crown (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). Each site will be graded based on a scale from 0 to 3 and the sum of all sites will calculate the overall GI ranging from 0 to 18 (0 being the best outcome possible and 18 the worst outcome possible). Gingival index scores will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Clinical measurements around implants: Gingival Index (GI)
Time frame: 3 months after crown delivery
Gingival index (GI) will be recorded at six sites around the implant crown (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). Each site will be graded based on a scale from 0 to 3 and the sum of all sites will calculate the overall GI ranging from 0 to 18 (0 being the best outcome possible and 18 the worst outcome possible). Gingival index scores will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Clinical measurements around implants: Gingival Index (GI)
Time frame: 6 months after crown delivery
Gingival index (GI) will be recorded at six sites around the implant crown (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). Each site will be graded based on a scale from 0 to 3 and the sum of all sites will calculate the overall GI ranging from 0 to 18 (0 being the best outcome possible and 18 the worst outcome possible). Gingival index scores will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Clinical measurements around implants: Probing depths (PD)
Time frame: baseline
Probing depths (PD) will be recorded at six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) from the gingival margin to the base of the sulcus around the implant crown. Each site will be measured in millimeters. Probing depths will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Clinical measurements around implants: Probing depths (PD)
Time frame: 3 months after crown delivery
Probing depths (PD) will be recorded at six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) from the gingival margin to the base of the sulcus around the implant crown. Each site will be measured in millimeters. Probing depths will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Clinical measurements around implants: Probing depths (PD)
Time frame: 6 months after crown delivery
Probing depths (PD) will be recorded at six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) from the gingival margin to the base of the sulcus around the implant crown. Each site will be measured in millimeters. Probing depths will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Clinical measurements around implants: Bleeding on probing (BOP)
Time frame: baseline
Bleeding on probing (BOP) will be recorded at six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) around the implant crown. BOP will be recorded as positive if it occurs within 30 seconds of probing and recorded as negative if it does not occur. BOP will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Clinical measurements around implants: Bleeding on probing (BOP)
Time frame: 3 months after crown delivery
Bleeding on probing (BOP) will be recorded at six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) around the implant crown. BOP will be recorded as positive if it occurs within 30 seconds of probing and recorded as negative if it does not occur. BOP will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Clinical measurements around implants: Bleeding on probing (BOP)
Time frame: 6 months after crown delivery
Bleeding on probing (BOP) will be recorded at six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) around the implant crown. BOP will be recorded as positive if it occurs within 30 seconds of probing and recorded as negative if it does not occur. BOP will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will result in improved clinical parameters that measure peri-implant health.
Degree of patient satisfaction
Time frame: 6 months after crown delivery
Patients will complete a visual analogue scale (VAS) questionnaire. On a scale from 0 to 10 (0 being the worst outcome possible and 10 the best outcome possible), patients will be asked their perception of pain during the procedure, 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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Edentulous Alveolar Ridge
Recruiting
Two-piece Zirconia Implants With Two Various Platforms
Edentulous Alveolar Ridge
Recruiting
Pontic Site Development With or Without Fixed Partial Denture
Mucogingival Defects, Pontic Site Development
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of dental implant, Placement of stock healing abutment and Placement of customized CAD/CAM healing abutment in people with Edentulous Alveolar Ridge, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear soft tissue changes around dental implants (time frame: baseline and 6 months after crown delivery). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.