Socket Preservation for Dental Implant Site Development.

NCT ID: NCT03112772

Last Updated: 2017-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-20

Study Completion Date

2017-11-20

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.

Detailed Description

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Conditions

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Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group III

No grafting materials will be inserted, so it serves as a negative control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group I

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).

Group Type EXPERIMENTAL

Puros® Allograft

Intervention Type OTHER

It is a type of bone grafting materials used for enhancing bone formation

Group II

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).

Group Type EXPERIMENTAL

CopiOs® Cancellous Particulate

Intervention Type OTHER

It is a type of bone grafting materials used for enhancing bone formation

Interventions

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Puros® Allograft

It is a type of bone grafting materials used for enhancing bone formation

Intervention Type OTHER

CopiOs® Cancellous Particulate

It is a type of bone grafting materials used for enhancing bone formation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Adult patient \> 18 years old.
2. Single and or multi-rooted teeth that are non-restorable.
3. Patients are keen to have implant placement at the extraction sites after 4 months of extraction.
4. Intact buccal bone after extraction, which was confirmed by visual inspection and clinical examination using a periodontal probe.
5. Patients are medically fit with no underlying systemic diseases.

Exclusion Criteria

1. Pregnant females.
2. Smokers.
3. Presence of any acute infection at the time of teeth extraction.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imam Abdulrahman Al Faisal Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hesham Marei

Associate professor and Consultant of Oral and Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Immam Abdulrahman Bin Faisal University

Dammam, Eastern Province, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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2014342

Identifier Type: -

Identifier Source: org_study_id

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