Tufts University School of Dental Medicine
Boston, Massachusetts, 02111, United States
NCT Number: NCT01808794
The purpose of the study is to compare one material called "Mucograft" with another material called "Dynamatrix." These materials are used as a type of a barrier (made from pig material also known as porcine material) in a preservation technique to increase the thickness and width of tissues at a tooth extraction site. The investigators want to see if one works better than the other or if they work equally as well. These materials are made up of collagens, which are naturally occurring proteins found in the skin, specifically connective tissue. Dynamatrix is made up of many types of collagens whereas Mucograft is only made of fewer collagens. These materials have been given something called a 510(k) status by the FDA. This means that the FDA determines them to be equivalent to another product that they have previously approved. You will be put into one of two groups at random, and will not know which one you are in. Like flipping a coin, you will have a 50/50 chance to be in either one of the two groups. You will either be in a group using Mucograft or in a group using Dynamatrix. Both of these materials are regularly used in the dental clinics.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02111, United States
A) Aim/Hypothesis/Objective The objective of this study is to compare two different membranes, Mucograft and Dynamatrix, clinically, radiographically, and histologically when used for the ridge preservation procedure in combination with bone allograft at the extraction site in terms of soft and hard tissue remodeling after 4 months healing period.
Hypothesis
Specific Aims
The secondary aims are to compare clinically, radiographically, and histologically MucograftTM with DynamatrixTM in relation to:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mucograft Collagen Matrix
Other names: 510(k) #K073711
Dynamatrix
Other names: 510(k) #K082058
Time frame: 4-6 Months after surgical procedure
The primary aim is to compare MucograftTM when used as a barrier membrane in the ridge preservation technique to increase or preserve the thickness and width of keratinized tissue at the extraction site in comparison to DynamatrixTM.
Time frame: 4-6 Months after surgical procedure
Compare clinically, radiographically, and histologically MucograftTM with DynamatrixTM in relation to changes of the alveolar bone height at the extraction site.
Tufts University
Other
Clinical, Radiographic, and Histological Comparison of Healing After Alveolar Ridge Preservation Using Bone Allograft With Two Different Xenogeneic Membranes
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