Clinical trial NCT05769673: Soft and Hard Tissue Changes Around Implants
Official title: Soft and Hard Tissue Changes Around Implants Using Customized CAD/CAM Healing Abutments
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Edentulous Alveolar Ridge
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Linear soft tissue changes around dental implants
timeFrame: baseline and 6 months after crown delivery
measure: Volumetric soft tissue changes around dental implants
timeFrame: baseline and 6 months after crown delivery
measure: Linear hard tissue changes around dental implants
timeFrame: baseline and 6 months after crown delivery
measure: Volumetric hard tissue changes around dental implants
timeFrame: baseline and 6 months after crown delivery
measure: Clinical measurements around implants: Plaque index (PI)
timeFrame: baseline
measure: Clinical measurements around implants: Plaque index (PI)
timeFrame: 3 months after crown delivery
measure: Clinical measurements around implants: Plaque index (PI)
timeFrame: 6 months after crown delivery
measure: Clinical measurements around implants: Gingival Index (GI)
timeFrame: baseline
measure: Clinical measurements around implants: Gingival Index (GI)
timeFrame: 3 months after crown delivery
measure: Clinical measurements around implants: Gingival Index (GI)
timeFrame: 6 months after crown delivery
measure: Clinical measurements around implants: Probing depths (PD)
timeFrame: baseline
measure: Clinical measurements around implants: Probing depths (PD)
timeFrame: 3 months after crown delivery
measure: Clinical measurements around implants: Probing depths (PD)
timeFrame: 6 months after crown delivery
measure: Clinical measurements around implants: Bleeding on probing (BOP)
timeFrame: baseline
measure: Clinical measurements around implants: Bleeding on probing (BOP)
timeFrame: 3 months after crown delivery
measure: Clinical measurements around implants: Bleeding on probing (BOP)
timeFrame: 6 months after crown delivery
measure: Degree of patient satisfaction
timeFrame: 6 months after crown delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University School of Dental Medicine
state: North Carolina
Study officials:
References: