Effect of Alveolar Ridge Preservation on Implant Esthetic Outcomes

Phase 4

Completed

• Conditions: Partial Edentulism
• Interventions: Drug: no-preservation of alveolar ridge - 4 months; Drug: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months; Drug: no-preservation of alveolar ridge - 2 months; Procedure: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months; Drug: no-preservation of alveolar ridge - 9 months; Drug: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months

• Registration Number: NCT02507661
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-11
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-24
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no-preservation of alveolar ridge - 4 months	no-preservation of alveolar ridge - 4 months	no-preservation of alveolar ridge - 4 months
alveolar ridge preservation - 2 months	preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months	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	no-preservation of alveolar ridge - 2 months
preservation of alveolar ridge - 9 months	preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months	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	no-preservation of alveolar ridge - 9 months
preservation of alveolar ridge - 4 months	preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months	preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months

Primary Outcome Measures

Name	Time	Method
implant stability analysis at the time of implant placement	baseline	Implant stability will be measured by the resonance frequency analysis
implant stability analysis 3 weeks after implant placement	baseline, 3 weeks	Implant stability will be measured by the resonance frequency analysis
implant stability analysis 6 weeks after implant placement	baseline, 6 weeks	Implant stability will be measured by the resonance frequency analysis
implant stability analysis 8 weeks after implant placement	baseline, 8 weeks	Implant stability will be measured by the resonance frequency analysis
change in pink and white esthetic score 2 months of loading	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	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	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

Name	Time	Method
analysis of new bone formation 2 months after preservation of alveolar ridge	2 months	New bone formation will be assessed by histological analysis and histomorphometrical measurement
analysis of new bone formation 4 months after preservation of alveolar ridge	4 months	New bone formation will be assessed by histological analysis and histomorphometrical measurement
analysis of new bone formation 9 months after preservation of alveolar ridge	9 months	New bone formation will be assessed by histological analysis and histomorphometrical measurement

Trial Locations

Locations (1)

School of Dental Medicine, University of Belgrade; 🇷🇸 Belgrade, Serbia