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Completed

NCT Number: NCT02507661

Effect of Alveolar Ridge Preservation on Implant Esthetic Outcomes

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

School of Dental Medicine, University of Belgrade

Belgrade, 11000, Serbia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Procedure

no-preservation of alveolar ridge - 9 months

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2015
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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