Soft and Hard Tissue Changes Around Implants

Edentulous Alveolar Ridge Clinical Trial

Official title:

Soft and Hard Tissue Changes Around Implants Using Customized CAD/CAM Healing Abutments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05769673
• Other study ID #: 21-000291
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
• 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

Related Conditions & MeSH terms

• Edentulous Alveolar Ridge
• Mouth, Edentulous

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	East Carolina University School of Dental Medicine	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and 6 months after crown delivery
Primary	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.	baseline and 6 months after crown delivery
Primary	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.	baseline and 6 months after crown delivery
Primary	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.	baseline and 6 months after crown delivery
Primary	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.	baseline
Primary	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.	3 months after crown delivery
Primary	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.	6 months after crown delivery
Primary	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.	baseline
Primary	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.	3 months after crown delivery
Primary	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.	6 months after crown delivery
Primary	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.	baseline
Primary	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.	3 months after crown delivery
Primary	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.	6 months after crown delivery
Primary	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.	baseline
Primary	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.	3 months after crown delivery
Primary	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.	6 months after crown delivery
Primary	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.	6 months after crown delivery