|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02507661 |
|
Date of registration:
|
11/06/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Alveolar Ridge Preservation on Implant Esthetic Outcomes
|
|
Scientific title:
|
Esthetic Outcomes of Implant-supported Crowns After Alveolar Ridge Preservation With Beta Tricalcium Phosphate and Collagen in the Maxillary Esthetic Zone |
|
Date of first enrolment:
|
June 2015 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02507661 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Serbia
| | | | | | | |
|
Contacts
|
|
Name:
|
Bozidar M Brkovic, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
School of Dental Medicine, University of Belgrade |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- healthy patients according to Classification of American Society of Anesthesiologists
(ASA I)
- presence of 4 socket walls
- non-smokers
- good oral hygiene
- good occlusion
Exclusion Criteria:
- patients with alveolar ridge height less than 12 mm
- presence of acute or chronic oro-facial pain
- acute periapical infection
- injured soft tissue
- patients who had dental interventions in last 7 days
- patients who had any medications within last 24 hours
- patients with bruxism and para-functions
- patients with allergies to any of applied materials
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Partial Edentulism
|
|
Intervention(s)
|
|
Drug: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months
|
|
Drug: no-preservation of alveolar ridge - 2 months
|
|
Drug: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months
|
|
Drug: no-preservation of alveolar ridge - 4 months
|
|
Drug: no-preservation of alveolar ridge - 9 months
|
|
Procedure: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months
|
|
Primary Outcome(s)
|
|
change in pink and white esthetic score 12 months of loading
[Time Frame: 12 months]
|
|
implant stability analysis 3 weeks after implant placement
[Time Frame: baseline, 3 weeks]
|
|
implant stability analysis 6 weeks after implant placement
[Time Frame: baseline, 6 weeks]
|
|
implant stability analysis at the time of implant placement
[Time Frame: baseline]
|
|
change in pink and white esthetic score 2 months of loading
[Time Frame: 2 months]
|
|
change in pink and white esthetic score 6 months of loading
[Time Frame: 6 months]
|
|
implant stability analysis 8 weeks after implant placement
[Time Frame: baseline, 8 weeks]
|
|
Secondary Outcome(s)
|
|
analysis of new bone formation 9 months after preservation of alveolar ridge
[Time Frame: 9 months]
|
|
analysis of new bone formation 2 months after preservation of alveolar ridge
[Time Frame: 2 months]
|
|
analysis of new bone formation 4 months after preservation of alveolar ridge
[Time Frame: 4 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|