Effect of Alveolar Ridge Preservation on Implant Esthetic Outcomes
Esthetic Outcomes of Implant-supported Crowns After Alveolar Ridge Preservation With Beta Tricalcium Phosphate and Collagen in the Maxillary Esthetic Zone
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to evaluate esthetic outcome of implant supported single crowns after alveolar ridge preservation with beta three calcium phosphate with collagen type I in aesthetic region in upper jaw.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2015
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 11, 2015
CompletedFirst Posted
Study publicly available on registry
July 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedMarch 23, 2018
March 1, 2018
2.6 years
June 11, 2015
March 21, 2018
Conditions
Outcome Measures
Primary Outcomes (7)
implant stability analysis at the time of implant placement
Implant stability will be measured by the resonance frequency analysis
baseline
implant stability analysis 3 weeks after implant placement
Implant stability will be measured by the resonance frequency analysis
baseline, 3 weeks
implant stability analysis 6 weeks after implant placement
Implant stability will be measured by the resonance frequency analysis
baseline, 6 weeks
implant stability analysis 8 weeks after implant placement
Implant stability will be measured by the resonance frequency analysis
baseline, 8 weeks
change in pink and white esthetic score 2 months of loading
Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns
2 months
change in pink and white esthetic score 6 months of loading
Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns
6 months
change in pink and white esthetic score 12 months of loading
Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns
12 months
Secondary Outcomes (3)
analysis of new bone formation 2 months after preservation of alveolar ridge
2 months
analysis of new bone formation 4 months after preservation of alveolar ridge
4 months
analysis of new bone formation 9 months after preservation of alveolar ridge
9 months
Study Arms (6)
alveolar ridge preservation - 2 months
EXPERIMENTALpreservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months
no-preservation of alveolar ridge - 2 months
ACTIVE COMPARATORno-preservation of alveolar ridge - 2 months
preservation of alveolar ridge - 4 months
EXPERIMENTALpreservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months
no-preservation of alveolar ridge - 4 months
ACTIVE COMPARATORno-preservation of alveolar ridge - 4 months
preservation of alveolar ridge - 9 months
EXPERIMENTALpreservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months
no-preservation of alveolar ridge - 9 months
ACTIVE COMPARATORno-preservation of alveolar ridge - 9 months
Interventions
Eligibility Criteria
You may qualify if:
- healthy patients according to Classification of American Society of Anesthesiologists (ASA I)
- presence of 4 socket walls
- non-smokers
- good oral hygiene
- good occlusion
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Dental Medicine, University of Belgrade
Belgrade, 11000, Serbia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bozidar M Brkovic, PhD
School of Dental Medicine, University of Belgrade
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DDS PhD Professor
Study Record Dates
First Submitted
June 11, 2015
First Posted
July 24, 2015
Study Start
June 1, 2015
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
March 23, 2018
Record last verified: 2018-03