|
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: |
NCT03305679 |
|
Date of registration:
|
02/10/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Clinical Efficacy of the Immediate Implant Loading
|
|
Scientific title:
|
Evaluation of the Clinical Efficacy of the Immediate Implant Loading in the Aesthetic Zone |
|
Date of first enrolment:
|
January 19, 2017 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03305679 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Lebanon
|
Syrian Arab Republic
| | | | | | |
|
Contacts
|
|
Name:
|
Mirza Allaf, DDS MSc PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Professor of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria |
|
|
Name:
|
Osama Yousuf Solieman, DDS MSc PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Laboratoire Bioinge Ânierie et Nanosciences EA4203, Montpellier University, Montpellier, France |
|
|
Name:
|
Christian Makary, DDS MSc PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Professor of Oral Implantology, Sante Jousef University, School of Dental Medicine, Beirut, Lebanon |
|
|
Name:
|
Anas Abdo, DDS MSc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
PhD student in Fixed Prosthodontics, Department of Fixed Prosthodontics, University of Damascus Dental School |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. esthetic request.
2. either incisor or canine indicated for extraction.
3. symmetrical gingival level.
4. no active periodontal disease.
5. age between 20-40 years old
Exclusion Criteria:
1. Lateral hopeless tooth .
2. Active periodontal lesion .
3. loss of periodontal tissue .
4. missed incisor or missed canine in the area of implantation.
Age minimum:
20 Years
Age maximum:
40 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Implant Site Reaction
|
|
Intervention(s)
|
|
Procedure: Direct provisional technique
|
|
Procedure: Indirect Provisional technique
|
|
Primary Outcome(s)
|
|
Change in the Plaque Index
[Time Frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation]
|
|
Change in Esthetic Appearance
[Time Frame: T1: at one day before implantation, T2: at three months following implantation]
|
|
Change in the Gingival Index
[Time Frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation]
|
|
Change in alveolar bone level
[Time Frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation]
|
|
Change in the Pink Esthetic Scale
[Time Frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation]
|
|
Secondary Outcome(s)
|
|
Change in Restoration Color
[Time Frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation]
|
|
Secondary ID(s)
|
|
UDDS-FixPro-01-2017
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|