ClinicalTrials.gov
ClinicalTrials.gov Menu

Socket Preservation for Dental Implant Site Development.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03112772
Recruitment Status : Active, not recruiting
First Posted : April 13, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Hesham Marei, 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.

Condition or disease Intervention/treatment Phase
Bone Loss Other: Puros® Allograft Other: CopiOs® Cancellous Particulate Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Socket Preservation for Dental Implant Site Development.
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : July 20, 2017
Estimated Study Completion Date : November 20, 2017

Arm Intervention/treatment
Experimental: 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).
Other: Puros® Allograft
It is a type of bone grafting materials used for enhancing bone formation
Experimental: 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).
Other: CopiOs® Cancellous Particulate
It is a type of bone grafting materials used for enhancing bone formation
No Intervention: Group III
No grafting materials will be inserted, so it serves as a negative control group.



Primary Outcome Measures :
  1. Width of alveolar ridge [ Time Frame: 4 months ]
    The distance from the buccal to the lingual surface of the alveolar ridge

  2. height of the alveolar ridge [ Time Frame: 4 months ]
    The distance from the crest of the ridge to the base of the socket

  3. Need of further grafting at the time of implant placement [ Time Frame: 4 months ]
    Ability to place implants


Secondary Outcome Measures :
  1. Osseintegration of implants [ Time Frame: 4 months ]
    Implant loss before restoration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112772


Locations
Saudi Arabia
Immam Abdulrahman Bin Faisal University
Dammam, Eastern, Saudi Arabia, 31441
Sponsors and Collaborators
Imam Abdulrahman Al Faisal Hospital

Responsible Party: Hesham Marei, Associate professor and Consultant of Oral and Maxillofacial Surgery, Imam Abdulrahman Al Faisal Hospital
ClinicalTrials.gov Identifier: NCT03112772     History of Changes
Other Study ID Numbers: 2014342
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available after statistical analysis

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No