Comparison of Two Different Membranes

NCT ID: NCT01808794

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

Partial Edentulism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mucograft

Placement of randomized membrane on half of subjects Mucograft

Group Type: ACTIVE_COMPARATOR

Mucograft

Intervention Type: DEVICE

Mucograft Collagen Matrix

Dynamatrix

Placement of randomized membrane on half of subjects Dynamatrix Membrane Placement

Group Type: ACTIVE_COMPARATOR

Dynamatrix

Intervention Type: DEVICE

Dynamatrix

Interventions

Mucograft

Mucograft Collagen Matrix

Intervention Type: DEVICE

Dynamatrix

Dynamatrix

Intervention Type: DEVICE

Other Intervention Names

510(k) #K073711; 510(k) #K082058

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Hanley, DMD

Role: PRINCIPAL_INVESTIGATOR

TUSDM

Youngsoo Kim, DDS

Role: STUDY_DIRECTOR

TUSDM

Locations

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

10551

Identifier Type: OTHER

Identifier Source: secondary_id

TUSDM10551

Identifier Type: -

Identifier Source: org_study_id