Effect of Alveolar Ridge Preservation on Implant Esthetic Outcomes

Partial Edentulism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507661
• Other study ID #: 36/21
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2015
• Last updated: March 21, 2018
• Start date: June 2015
• Est. completion date: January 2018

Study information

• Verified date: March 2018
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Partial Edentulism

Intervention

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

• no-preservation of alveolar ridge - 2 months

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

• 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

Locations

Country	Name	City	State
Serbia	School of Dental Medicine, University of Belgrade	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implant stability analysis at the time of implant placement	Implant stability will be measured by the resonance frequency analysis	baseline
Primary	implant stability analysis 3 weeks after implant placement	Implant stability will be measured by the resonance frequency analysis	baseline, 3 weeks
Primary	implant stability analysis 6 weeks after implant placement	Implant stability will be measured by the resonance frequency analysis	baseline, 6 weeks
Primary	implant stability analysis 8 weeks after implant placement	Implant stability will be measured by the resonance frequency analysis	baseline, 8 weeks
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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