NCT02507661

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

2.6 years

First QC Date

June 11, 2015

Last Update Submit

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

EXPERIMENTAL

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

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

no-preservation of alveolar ridge - 2 months

ACTIVE COMPARATOR

no-preservation of alveolar ridge - 2 months

Drug: no-preservation of alveolar ridge - 2 months

preservation of alveolar ridge - 4 months

EXPERIMENTAL

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

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

no-preservation of alveolar ridge - 4 months

ACTIVE COMPARATOR

no-preservation of alveolar ridge - 4 months

Drug: no-preservation of alveolar ridge - 4 months

preservation of alveolar ridge - 9 months

EXPERIMENTAL

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

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

no-preservation of alveolar ridge - 9 months

ACTIVE COMPARATOR

no-preservation of alveolar ridge - 9 months

Drug: no-preservation of alveolar ridge - 9 months

Interventions

no-preservation of alveolar ridge - 2 months
no-preservation of alveolar ridge - 4 months
no-preservation of alveolar ridge - 9 months

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Interventions

beta-tricalcium phosphateCollagen

Intervention Hierarchy (Ancestors)

BiopolymersPolymersMacromolecular SubstancesExtracellular Matrix ProteinsScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Bozidar M Brkovic, PhD

    School of Dental Medicine, University of Belgrade

    PRINCIPAL INVESTIGATOR

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

Locations