Socket Preservation for Dental Implant Site Development.

Study Overview
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Brief Summary
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Changes in alveolar bone following teeth extraction can compromise implant placement. Socket preservation (alveolar ridge preservation) is considered as a surgical procedure employed to preserve the ridge volume within the envelope existing at the time of extraction.The ultimate aim of such procedure is to compensate the expected amount of horizontal and vertical alveolar bone resorption. In order to better understand which socket preservation materials might be more effective for ridge preservation and to strengthen the evidence that is relevant to the clinicians' choice of socket preservation materials, two different materials were compared in a randomized controlled approach. (1) Demineralized Bone Matrix (DBM) Putty and Putty with Chips allograft covered by collagen membrane, and (2) Deprotonated bovine bone xenograft covered by collagen membrane. The independent variable is the grafting material while the dependent variables are the change in socket height, and width; the ability of implant placement without the need for grafting and the success rate of implants at the time of loading.

Official Title
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Socket Preservation for Dental Implant Site Development.

Conditions
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Bone Loss

Intervention / Treatment
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* Other: Puros® Allograft
* Other: CopiOs® Cancellous Particulate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient > 18 years old. Single and or multi-rooted teeth that are non-restorable. Patients are keen to have implant placement at the extraction sites after 4 months of extraction. Intact buccal bone after extraction, which was confirmed by visual inspection and clinical examination using a periodontal probe. Patients are medically fit with no underlying systemic diseases. Exclusion Criteria: Pregnant females. Smokers. Presence of any acute infection at the time of teeth extraction.

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>Participants who are receiving socket preservation using allograft (Puros® Allograft, Zimmer dental, Zimmer, USA) covered by membrane (size: 15x20mm) made of type I collagen fibers purified from bovine tendon (BioMend® Membrane, Zimmer dental, Zimmer, USA). | Other: Puros® Allograft<br>* It is a type of bone grafting materials used for enhancing bone formation<br>|
| Experimental: Group II<br>Participants who are receiving socket preservation cancellous particulate bovine bone xenograft (CopiOs® Cancellous Particulate, Zimmer dental, Zimmer, USA) covered by membrane (size: 15x20mm) made of type I collagen fibers purified from bovine tendon (BioMend® Membrane, 15x20mm, Zimmer dental, Zimmer, USA). | Other: CopiOs® Cancellous Particulate<br>* It is a type of bone grafting materials used for enhancing bone formation<br>|
| No Intervention: Group III<br>No grafting materials will be inserted, so it serves as a negative control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Width of alveolar ridge | The distance from the buccal to the lingual surface of the alveolar ridge | 4 months | 
| height of the alveolar ridge | The distance from the crest of the ridge to the base of the socket | 4 months | 
| Need of further grafting at the time of implant placement | Ability to place implants | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osseintegration of implants | Implant loss before restoration | 4 months |