Comparison of Two Different Membranes

NCT01808794 | Completed Results

• 2 other identifiers: TUSDM1055110551
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Partial Edentulism

Keywords

membranes; Mucograft; Dynamatrixw; ridge; preservation; bone; allograft; extraction; site; healing

Outcome Measures

Primary Outcomes (1)

• Compare Barrier Membranes by Examining Keratinized Tissue

  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.

  4-6 Months after surgical procedure

Secondary Outcomes (1)

• Alveolar Bone Height

  4-6 Months after surgical procedure

Study Arms (2)

Mucograft

ACTIVE COMPARATOR

Placement of randomized membrane on half of subjects Mucograft

Device: Mucograft

Dynamatrix

ACTIVE COMPARATOR

Placement of randomized membrane on half of subjects Dynamatrix Membrane Placement

Device: Dynamatrix

Interventions

Mucograft DEVICE

Mucograft Collagen Matrix

Also known as: 510(k) #K073711

Mucograft

Dynamatrix DEVICE

Dynamatrix

Also known as: 510(k) #K082058

Dynamatrix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age.
• 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.
• 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).
• Display no evidence of acute periodontal infection: e.g., abscess, suppuration, severe swelling and/or spontaneous bleeding.
• Smoke less than 10 cigarettes per day.
• Not participating in any other dental research study for the duration of this study.

You may not qualify if:

• 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).
• Have a history of severe psychological conditions or limited mental capacity.
• 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).
• Individuals opposed to having porcine derived materials placed in their mouth.

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

Results Point of Contact

• Title: Associate Vice Provost for Research Administration & Development
• Organization: Tufts University

tss@tufts.edu

617-627-7000

Study Officials

• James Hanley, DMD

  TUSDM

  PRINCIPAL INVESTIGATOR

• Youngsoo Kim, DDS

  TUSDM

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 11, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 19, 2020
• Results First Posted: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)