Status:

COMPLETED

Comparison of Two Different Membranes

Lead Sponsor:

Tufts University

Conditions:

Partial Edentulism

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

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 preser...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

January 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2016

Estimated Enrollment :

27 Patients enrolled

Trial Details

Trial ID

NCT01808794

Start Date

January 1 2013

End Date

January 1 2016

Last Update

February 19 2020

Active Locations (1)

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1

Tufts University School of Dental Medicine

Boston, Massachusetts, United States, 02111