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Clinical Trials/NCT02507661
NCT02507661
Completed
Phase 4

Esthetic Outcomes of Implant-supported Crowns After Alveolar Ridge Preservation With Beta Tricalcium Phosphate and Collagen in the Maxillary Esthetic Zone

University of Belgrade1 site in 1 country50 target enrollmentJune 2015

Overview

Phase
Phase 4
Intervention
preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months
Conditions
Partial Edentulism
Sponsor
University of Belgrade
Enrollment
50
Locations
1
Primary Endpoint
implant stability analysis at the time of implant placement
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
January 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bozidar Brkovic, DDS, MSc, PhD, Professor

DDS PhD Professor

University of Belgrade

Eligibility 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

Arms & Interventions

alveolar ridge preservation - 2 months

preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months

Intervention: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months

no-preservation of alveolar ridge - 2 months

no-preservation of alveolar ridge - 2 months

Intervention: no-preservation of alveolar ridge - 2 months

preservation of alveolar ridge - 4 months

preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months

Intervention: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months

no-preservation of alveolar ridge - 4 months

no-preservation of alveolar ridge - 4 months

Intervention: no-preservation of alveolar ridge - 4 months

preservation of alveolar ridge - 9 months

preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months

Intervention: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months

no-preservation of alveolar ridge - 9 months

no-preservation of alveolar ridge - 9 months

Intervention: no-preservation of alveolar ridge - 9 months

Outcomes

Primary Outcomes

implant stability analysis at the time of implant placement

Time Frame: baseline

Implant stability will be measured by the resonance frequency analysis

implant stability analysis 3 weeks after implant placement

Time Frame: baseline, 3 weeks

Implant stability will be measured by the resonance frequency analysis

implant stability analysis 6 weeks after implant placement

Time Frame: baseline, 6 weeks

Implant stability will be measured by the resonance frequency analysis

implant stability analysis 8 weeks after implant placement

Time Frame: baseline, 8 weeks

Implant stability will be measured by the resonance frequency analysis

change in pink and white esthetic score 2 months of loading

Time Frame: 2 months

Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns

change in pink and white esthetic score 6 months of loading

Time Frame: 6 months

Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns

change in pink and white esthetic score 12 months of loading

Time Frame: 12 months

Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns

Secondary Outcomes

  • 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 Sites (1)

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