RECRUITING

Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice

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

Periodontitis is a bacterial inflammatory disease and antibiotic use is being empirically used as part of its treatment. However, a clinical practice guideline on periodontal treatment adjuncts published in 2015 identified weak evidence on the use of systemic antibiotics and large heterogeneity across small scale studies, suggesting that larger pragmatic clinical trials would benefit clinical decision making. This will be a prospective, randomized, placebo-controlled trial, stratified by practice and practitioner. The study will investigate the effectiveness of adjunctive antibiotics as adjunct to scaling and root planing (SRP) compared to SRP with placebo for the treatment of generalized stage II-III, grades A-C periodontitis in patient participants from National Dental PBRN practices. Periodontal data will be collected at baseline, re-evaluation (6 weeks), and final (4-12 months) study visits. Changes in periodontal clinical and patient-reported outcomes will be assessed to determine the effectiveness of SRP plus adjunctive systemic Amoxicillin / Metronidazole antibiotics (AMXM) versus SRP with Placebo.

Official Title

Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice: A PBRN Clinical Trial

Quick Facts

Study Start:2024-04-25
Study Completion:2026-05-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06131021

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:35 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The study will recruit patient participants presenting for periodontal treatment within the National Dental PBRN practices participating in this study.
  2. * Adult who is at least 35 years old.
  3. * Presence of ≥ 15 permanent teeth excluding 3rd molars.
  4. * In good general health as evidenced by medical history (ASA Class I or II) per the practitioner.
  5. * Planned to receive periodontal care for Generalized Periodontitis and a minimum of two quadrants of SRP (CDT code 4341) in practices participating in the National Dental PBRN.
  6. * Willing to comply with all study visits and be available for the duration of the study (12-15 months)
  7. * Willing to provide contact information for self, including a cellular phone number for study text, and one to two emergency contacts to be reached for the follow-up visits and any other study-related matters for the duration of the study.
  1. * Known drug allergy to any antibiotics or anesthetics.
  2. * Use of systemic antibiotics taken within the previous 3 months prior to enrollment.
  3. * Medical condition which requires antibiotic prophylaxis prior to dental treatments/visits.
  4. * Current use of medications that, in the opinion of the practitioner, may cause adverse effects with AMXM (such as disulfiram, warfarin, and oral contraceptives).
  5. * History of any periodontal therapy (including SRP D4341, D4342) within the last 6 months prior to enrollment.
  6. * Is currently pregnant or lactating per patient participant self-report.
  7. * Is considered immunocompromised, in the opinion of the practitioner (including diseases and conditions such as HIV/AIDS, immunosuppressive drug therapy and/or radiation), or has chronic mucosal lesions (e.g. pemphigus vulgaris) affecting the gingiva.
  8. * Has Diabetes mellitus with an HbA1c score of \>/= 10% within the past 3 months as per patient participant self-report.

Contacts and Locations

Study Contact

Varvara Chrepa, DDS, PhD
CONTACT
973-972-7331
vc551@sdm.rutgers.edu

Principal Investigator

Georgios Kotsakis, DDS
PRINCIPAL_INVESTIGATOR
Rutgers University

Study Locations (Sites)

University of Alabame
Birmingham, Alabama, 35233
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Georgios Kotsakis, DDS, PRINCIPAL_INVESTIGATOR, Rutgers University

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 Date2024-04-25
Study Completion Date2026-05-26

Study Record Updates

Study Start Date2024-04-25
Study Completion Date2026-05-26

Terms related to this study

Keywords Provided by Researchers

  • Antibiotics
  • Amoxicillin
  • Metronidazole

Additional Relevant MeSH Terms

  • Periodontitis
  • Periodontal Diseases
  • Periodontal Pocket