Socket Preservation for Dental Implant Site Development.

Bone Loss Clinical Trial

Official title:

Socket Preservation for Dental Implant Site Development.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03112772
• Other study ID #: 2014342
• 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
• 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.

Related Conditions & MeSH terms

• Bone Loss

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