RECRUITING

Guided Bone Regeneration With and Without the Use of Intra-marrow Penetrations

Conditions

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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

The primary aims of this study are to compare, after 6 months, the clinical and histologic results of intra-marrow penetrations vs no intra-marrow penetrations when performing guided bone regeneration procedures.

Official Title

Guided Bone Regeneration With and Without Use of Intra-marrow Penetrations: A Prospective Human Clinical and Histologic Study

Quick Facts

Study Start:2023-06-15

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06353399

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 Criteria	Exclusion Criteria
* Healthy male or female who is at least 18 years old. * Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.	* Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium. * Presence or history of osteonecrosis of jaws. * Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration. * Patients who have been treated with oral bisphosphonates for more than three years. * Patients with an allergy to any material or medication used in the study. * Patients who need prophylactic antibiotics * Previous head and neck radiation therapy. * Chemotherapy in the previous 12 months. * Patients on long term NSAID or steroid therapy. * Pregnant patients.

Inclusion Criteria

Exclusion Criteria

* Healthy male or female who is at least 18 years old.
* Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

* Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
* Presence or history of osteonecrosis of jaws.
* Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
* Patients who have been treated with oral bisphosphonates for more than three years.
* Patients with an allergy to any material or medication used in the study.
* Patients who need prophylactic antibiotics
* Previous head and neck radiation therapy.
* Chemotherapy in the previous 12 months.
* Patients on long term NSAID or steroid therapy.
* Pregnant patients.

Contacts and Locations

Study Contact

Himabindu Dukka, DMD

CONTACT

502-852-1817

himabindu.dukka@louisville.edu

Niti Patel, DMD

CONTACT

502-852-1817

ndpate02@louisville.edu

Study Locations (Sites)

University of Louisville

Louisville, Kentucky, 40202

United States

University of Louisville

Louisville, Kentucky, 40202

United States

Collaborators and Investigators

Sponsor: 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 Date2023-06-15

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-06-15

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Ridge Augmentation