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Comparison of Two Different Membranes

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ClinicalTrials.gov Identifier: NCT01808794
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Tufts University

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.

Condition or disease Intervention/treatment Phase
Partial Edentulism Device: Mucograft Device: Dynamatrix Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical, Radiographic, and Histological Comparison of Healing After Alveolar Ridge Preservation Using Bone Allograft With Two Different Xenogeneic Membranes
Study Start Date : January 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Active Comparator: Mucograft
Placement of randomized membrane on half of subjects Mucograft
Device: Mucograft
Mucograft Collagen Matrix
Other Name: 510(k) #K073711

Active Comparator: Dynamatrix
Placement of randomized membrane on half of subjects Dynamatrix Membrane Placement
Device: Dynamatrix
Dynamatrix
Other Name: 510(k) #K082058




Primary Outcome Measures :
  1. Compare barrier membranes by examining keratinized tissue [ 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.


Secondary Outcome Measures :
  1. alveolar bone height [ 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.

  2. soft tissues [ Time Frame: 4-6 Months after surgical procedure ]
    Compare clinically, radiographically, and histologically MucograftTM with DynamatrixTM in relation to changes of the soft tissues at the adjacent teeth.

  3. healing at the extraction site [ Time Frame: 4-6 Months after surgical procedure ]
    Compare clinically, radiographically, and histologically MucograftTM with DynamatrixTM in relation to histological and histomorphometric assessment of the soft and hard tissue healing at the extraction site.

  4. alveolar bone width [ Time Frame: 4-6 Months after surgical procedure ]
    Compare clinically, radiographically, and histologically MucograftTM with DynamatrixTM in relation to changes of the alveolar bone width at the extraction site.

  5. hard tissues [ Time Frame: 4-6 Months after surgical procedure ]
    Compare clinically, radiographically, and histologically MucograftTM with DynamatrixTM in relation to changes of the hard tissues at the adjacent teeth.



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

Inclusion Criteria:

  1. Be at least 18 years of age.
  2. Have unsalvageable non-adjacent non-molar teeth: maxillary incisors, canines, and premolars, and mandibular canines and premolars that require an extraction with bone augmentation planned for delayed implant placement. If a subject has multiple teeth to be extracted, only one tooth will be included in the study.
  3. Patients who are currently treatment planned in the Tufts University School of Dental Medicine (TUSDM) periodontology clinic to receive bone augmentation and delayed implant placement and meet all medical and dental requirements of the TUSDM periodontology clinic for periodontal surgery (e.g., subjects with no diseases or medication allergies contraindicating periodontal surgery).
  4. Display no evidence of acute periodontal infection: e.g., abscess, suppuration, severe swelling and/or spontaneous bleeding.
  5. Smoke less than 10 cigarettes per day.
  6. Not participating in any other dental research study for the duration of this study.

Exclusion Criteria:

  1. Have any known disease that interferes with periodontal surgery and would not allow the patient to be treatment planned for the procedures in the TUSDM periodontology clinic (e.g., severe anemia, low white blood cell count, bleeding or coagulation disorder, uncontrolled hypertension, recent myocardial infarction (within 6 months of enrollment), poorly controlled diabetes, HIV/AIDS (self-reported), history of or currently undergoing head and neck radiation, history of or currently taking bisphosphonates).
  2. Have a history of severe psychological conditions or limited mental capacity.
  3. Be a pregnant or lactating female (self-reported) (following TUSDM periodontology clinic guidelines elective surgical procedures and radiographs/CBCT scans are usually postponed until after delivery).
  4. Individuals opposed to having porcine derived materials placed in their mouth.

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): NCT01808794


Locations
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United States, Massachusetts
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Investigators
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Principal Investigator: James Hanley, DMD TUSDM
Study Director: Youngsoo Kim, DDS TUSDM

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Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01808794     History of Changes
Other Study ID Numbers: TUSDM10551
10551 ( Other Identifier: Tufts University IRB )
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tufts University:
membranes
Mucograft
Dynamatrixw
ridge
preservation
bone
allograft
extraction
site
healing