Socket Preservation for Dental Implant Site Development.

Socket Preservation for Dental Implant Site Development.

Sponsors

Lead sponsor: Imam Abdulrahman Al Faisal Hospital

Source Imam Abdulrahman Al Faisal Hospital
Brief Summary

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.

Overall Status Unknown status
Start Date March 20, 2017
Completion Date November 20, 2017
Primary Completion Date July 20, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Width of alveolar ridge 4 months
height of the alveolar ridge 4 months
Need of further grafting at the time of implant placement 4 months
Secondary Outcome
Measure Time Frame
Osseintegration of implants 4 months
Enrollment 100
Condition
Intervention

Intervention type: Other

Intervention name: Puros® Allograft

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

Arm group label: Group I

Intervention type: Other

Intervention name: CopiOs® Cancellous Particulate

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

Arm group label: Group II

Eligibility

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Location
facility
Immam Abdulrahman Bin Faisal University
Location Countries

Saudi Arabia

Verification Date

April 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Imam Abdulrahman Al Faisal Hospital

Investigator full name: Hesham Marei

Investigator title: Associate professor and Consultant of Oral and Maxillofacial Surgery

Has Expanded Access No
Number Of Arms 3
Arm Group

Arm group label: Group I

Arm group type: Experimental

Description: 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).

Arm group label: Group II

Arm group type: Experimental

Description: 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).

Arm group label: Group III

Arm group type: No Intervention

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

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov