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NCT05769673
Soft and Hard Tissue Changes Around Implants
NA trial testing Placement of dental implant in Edentulous Alveolar Ridge in 30 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2024
Quick facts
| Lead sponsor | East Carolina University |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 September 2022 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Placement of dental implant
- Placement of stock healing abutment
- Placement of customized CAD/CAM healing abutment
Conditions studied
- Edentulous Alveolar Ridge — all drugs for Edentulous Alveolar Ridge →
Sponsor
East Carolina University
Who can join
18 and older, any sex, with Edentulous Alveolar Ridge. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05769673
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05769673 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by East Carolina University
- Last refreshed: 27 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05769673.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing