RECRUITING

Root Coverage Using ADM and Coronally Positioned Tunnel With or Without Enamel Matrix Derivative

Talk to us

Conditions

Recession, Gingivalesthetic surgeryallograftbiologic materialsacellular dermis

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

24 patients will be treated with a coronally positioned tunnel with AlloDerm RTM with or without the addition of Enamel Matrix Derivative to compare the baseline and 6-month changes in recession defect coverage, clinical attachment levels, amount of keratinized tissue width, and soft tissue thickness.

Official Title

Root Coverage Using Acellular Dermal Matrix and a Coronally Positioned Tunnel With or Without Biologic Materials

Quick Facts

Study Start:2022-10-06
Study Completion:2024-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05565079

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Presence of at least one Miller class 1 or 2 soft tissue recession defect \>3 mm on a non-molar tooth.
  2. * Healthy patients, at least 18 years of age.
  3. * Patient understands and signs an informed consent approved by the University of Louisville IRB.
  1. * Patients with debilitating systemic diseases, diseases that significantly affect the periodontium, infectious diseases, or psychological problems that may interfere with treatment.
  2. * Previous head and neck radiation or chemotherapy within the previous 12 months.
  3. * Patients with known allergies to any of the materials used in the study, including systemic antibiotics.
  4. * Patients that use tobacco products (smoking, smokeless tobacco, or electronic cigarettes).
  5. * Patients with alcohol abuse problems.
  6. * Patients requiring antibiotic prophylaxis for dental procedures.
  7. * Cemento-enamel unction not identifiable.
  8. * Root surface restorations at the recession site.
  9. * Patients undergoing long-term steroid therapy.
  10. * History of previous root coverage procedure, graft, or guided tissue regeneration involving the recession site.
  11. * Pregnant or lactating patients.
  12. * Patients who fail to maintain oral hygiene levels of at least 80% plaque-free surfaces.
  13. * Patients who fail to complete the informed consent form.

Contacts and Locations

Study Contact

Bindu Dukka, BDS, MSD, MPH
CONTACT
502-852-1817
himabindu.dukka@louisville.edu
Katelyn Fleming, DMD
CONTACT
423-863-1701
christina.fleming@louisville.edu

Principal Investigator

Bindu Dukka, BDS, MSD, MPH
PRINCIPAL_INVESTIGATOR
Director, Graduate Periodontics, University of Louisville

Study Locations (Sites)

University of Louisville
Louisville, Kentucky, 40202
United States

Collaborators and Investigators

Sponsor: University of Louisville

  • Bindu Dukka, BDS, MSD, MPH, PRINCIPAL_INVESTIGATOR, Director, Graduate Periodontics, University of Louisville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-06
Study Completion Date2024-10-30

Study Record Updates

Study Start Date2022-10-06
Study Completion Date2024-10-30

Terms related to this study

Keywords Provided by Researchers

  • esthetic surgery
  • allograft
  • biologic materials
  • acellular dermis

Additional Relevant MeSH Terms

  • Recession, Gingival