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Effect of Alveolar Ridge Preservation on Implant Esthetic Outcomes

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ClinicalTrials.gov Identifier: NCT02507661
Recruitment Status : Completed
First Posted : July 24, 2015
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Bozidar Brkovic, DDS, MSc, PhD, Professor, University of Belgrade

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.

Condition or disease Intervention/treatment Phase
Partial Edentulism Drug: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months Drug: no-preservation of alveolar ridge - 2 months Drug: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months Drug: no-preservation of alveolar ridge - 4 months Procedure: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months Drug: no-preservation of alveolar ridge - 9 months Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Esthetic Outcomes of Implant-supported Crowns After Alveolar Ridge Preservation With Beta Tricalcium Phosphate and Collagen in the Maxillary Esthetic Zone
Actual Study Start Date : June 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: alveolar ridge preservation - 2 months
preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months
Drug: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months
Active Comparator: no-preservation of alveolar ridge - 2 months
no-preservation of alveolar ridge - 2 months
Drug: no-preservation of alveolar ridge - 2 months
Experimental: preservation of alveolar ridge - 4 months
preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months
Drug: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months
Active Comparator: no-preservation of alveolar ridge - 4 months
no-preservation of alveolar ridge - 4 months
Drug: no-preservation of alveolar ridge - 4 months
Experimental: preservation of alveolar ridge - 9 months
preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months
Procedure: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months
Active Comparator: no-preservation of alveolar ridge - 9 months
no-preservation of alveolar ridge - 9 months
Drug: no-preservation of alveolar ridge - 9 months



Primary Outcome Measures :
  1. implant stability analysis at the time of implant placement [ Time Frame: baseline ]
    Implant stability will be measured by the resonance frequency analysis

  2. implant stability analysis 3 weeks after implant placement [ Time Frame: baseline, 3 weeks ]
    Implant stability will be measured by the resonance frequency analysis

  3. implant stability analysis 6 weeks after implant placement [ Time Frame: baseline, 6 weeks ]
    Implant stability will be measured by the resonance frequency analysis

  4. implant stability analysis 8 weeks after implant placement [ Time Frame: baseline, 8 weeks ]
    Implant stability will be measured by the resonance frequency analysis

  5. 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

  6. 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

  7. 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 Outcome Measures :
  1. analysis of new bone formation 2 months after preservation of alveolar ridge [ Time Frame: 2 months ]
    New bone formation will be assessed by histological analysis and histomorphometrical measurement

  2. analysis of new bone formation 4 months after preservation of alveolar ridge [ Time Frame: 4 months ]
    New bone formation will be assessed by histological analysis and histomorphometrical measurement

  3. analysis of new bone formation 9 months after preservation of alveolar ridge [ Time Frame: 9 months ]
    New bone formation will be assessed by histological analysis and histomorphometrical measurement



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507661


Locations
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Serbia
School of Dental Medicine, University of Belgrade
Belgrade, Serbia, 11000
Sponsors and Collaborators
University of Belgrade
Investigators
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Principal Investigator: Bozidar M Brkovic, PhD School of Dental Medicine, University of Belgrade
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Responsible Party: Bozidar Brkovic, DDS, MSc, PhD, Professor, DDS PhD Professor, University of Belgrade
ClinicalTrials.gov Identifier: NCT02507661    
Other Study ID Numbers: 36/21
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018