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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03112772
Other study ID # 2014342
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 8, 2017
Last updated April 15, 2017
Start date March 20, 2017
Est. completion date November 20, 2017

Study information

Verified date April 2017
Source Imam Abdulrahman Al Faisal Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date November 20, 2017
Est. primary completion date July 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Puros® Allograft
It is a type of bone grafting materials used for enhancing bone formation
CopiOs® Cancellous Particulate
It is a type of bone grafting materials used for enhancing bone formation

Locations

Country Name City State
Saudi Arabia Immam Abdulrahman Bin Faisal University Dammam Eastern

Sponsors (1)

Lead Sponsor Collaborator
Imam Abdulrahman Al Faisal Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Width of alveolar ridge The distance from the buccal to the lingual surface of the alveolar ridge 4 months
Primary height of the alveolar ridge The distance from the crest of the ridge to the base of the socket 4 months
Primary Need of further grafting at the time of implant placement Ability to place implants 4 months
Secondary Osseintegration of implants Implant loss before restoration 4 months
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