Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-04 @ 8:40 AM
Study NCT ID:
NCT01808794
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2013-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Two Different Membranes
Sponsor:
Tufts University
Organization:
Study Overview
Official Title:
Clinical, Radiographic, and Histological Comparison of Healing After Alveolar Ridge Preservation Using Bone Allograft With Two Different Xenogeneic Membranes
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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
1. MucograftTM will exhibit greater increase or preservation of the thickness and width of keratinized tissue than DynamatrixTM at the extraction site.
2. MucograftTM will exhibit greater preservation of the alveolar bone width and height than DynamatrixTM at the extraction site.
3. MucograftTM will exhibit greater preservation of the soft and hard tissue height than DynamatrixTM at the adjacent teeth.
4. MucograftTM will exhibit a better outcome than DynamatrixTM in the histological and histomorphometric results of the soft and hard tissue healing.
Specific Aims
1. Primary aim 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.
2. Secondary aims
The secondary aims are to compare clinically, radiographically, and histologically MucograftTM with DynamatrixTM in relation to:
1. Changes of the alveolar bone height and width at the extraction site.
2. Changes of the soft and hard tissues at the adjacent teeth.
3. Histological and histomorphometric assessment of the soft and hard tissue healing at the extraction site.
Hypothesis
1. MucograftTM will exhibit greater increase or preservation of the thickness and width of keratinized tissue than DynamatrixTM at the extraction site.
2. MucograftTM will exhibit greater preservation of the alveolar bone width and height than DynamatrixTM at the extraction site.
3. MucograftTM will exhibit greater preservation of the soft and hard tissue height than DynamatrixTM at the adjacent teeth.
4. MucograftTM will exhibit a better outcome than DynamatrixTM in the histological and histomorphometric results of the soft and hard tissue healing.
Specific Aims
1. Primary aim 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.
2. Secondary aims
The secondary aims are to compare clinically, radiographically, and histologically MucograftTM with DynamatrixTM in relation to:
1. Changes of the alveolar bone height and width at the extraction site.
2. Changes of the soft and hard tissues at the adjacent teeth.
3. Histological and histomorphometric assessment of the soft and hard tissue healing at the extraction site.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 10551 | OTHER | Tufts University IRB | View |