Effect of Alveolar Ridge Preservation on Implant Esthetic Outcomes

Study Overview
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Brief Summary
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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.

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

Conditions
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Partial Edentulism

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alveolar ridge preservation - 2 months<br>preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months | Drug: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months<br> <br> |
| Active Comparator: no-preservation of alveolar ridge - 2 months<br>no-preservation of alveolar ridge - 2 months | Drug: no-preservation of alveolar ridge - 2 months<br> <br> |
| Experimental: preservation of alveolar ridge - 4 months<br>preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months | Drug: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months<br> <br> |
| Active Comparator: no-preservation of alveolar ridge - 4 months<br>no-preservation of alveolar ridge - 4 months | Drug: no-preservation of alveolar ridge - 4 months<br> <br> |
| Experimental: preservation of alveolar ridge - 9 months<br>preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months | Procedure: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months<br> <br> |
| Active Comparator: no-preservation of alveolar ridge - 9 months<br>no-preservation of alveolar ridge - 9 months | Drug: no-preservation of alveolar ridge - 9 months<br> <br> |

What is the study measuring?
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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 |