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

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.

Study Overview

• Status: Completed
• Conditions: Partial Edentulism
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • School of dental medicine, University of Belgrade

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / 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	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	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	Drug: no-preservation of alveolar ridge - 9 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
analysis of new bone formation 2 months after preservation of alveolar ridge	New bone formation will be assessed by histological analysis and histomorphometrical measurement	2 months
analysis of new bone formation 4 months after preservation of alveolar ridge	New bone formation will be assessed by histological analysis and histomorphometrical measurement	4 months
analysis of new bone formation 9 months after preservation of alveolar ridge	New bone formation will be assessed by histological analysis and histomorphometrical measurement	9 months

Collaborators and Investigators

• Sponsor: University of Belgrade
• Investigators: Principal Investigator: Bozidar M Brkovic, PhD, School of dental medicine, University of Belgrade

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2015
• Primary Completion (ACTUAL): January 1, 2018
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: June 11, 2015
• First Submitted That Met QC Criteria: July 23, 2015
• First Posted (ESTIMATE): July 24, 2015

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2018
• Last Update Submitted That Met QC Criteria: March 21, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 36/21