Supportive Periodontal Therapy Under Antiresorptive Therapy

October 10, 2022 updated by: Dr. Antonio Ciardo, Heidelberg University
This observational study investigates the one-point in time and course of clinical periodontal and dental parameters during supportive periodontal therapy in patients under and without antiresorptive medication.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • University Hospital Heidelberg

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing supportive periodontal therapy (SPT) in the Section of Periodontology, Clinic of Conservative Dentistry, University Hospital Heidelberg

Description

Inclusion Criteria:

  • Patients undergoing supportive periodontal therapy (SPT) after completing anti-infectious therapy (AIT) in the Section of Periodontology, Clinic of Conservative Dentistry, University Hospital Heidelberg
  • Regular attendance to SPT (no interruption of interval of more than one year)
  • Existing radiographs (orthopantomogram or dental status) of up to six months before AIT
  • ART-group: patients on antiresorptive medication (underlying diseases: osteoporosis, cancer diseases)
  • Understanding of participation in this study and given informed consent

Exclusion Criteria:

  • Patients < 18 years
  • Patients who underwent radiation therapy
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ART-Group
Patients undergoing supportive periodontal therapy and independently antiresorptive therapy.
Control Group
Patients undergoing supportive periodontal therapy without the need for antiresorptive therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Is there a difference in the clinical attachment level between patients under antiresorptive therapy and without antiresorptive medication?
Time Frame: 0 months
0 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Is Intraoral digital photography suitable for DMFT and implants assessment?
Time Frame: 0 months
0 months
Is there a difference in the clinical attachmentlevel between baseline and 12 months after the beginning of supportive periodontal therapy in patients under antiresorptive therapy compared to patients without antiresorptive medication?
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Antonio Ciardo, Dr. med. dent., University Hospital Heidelberg

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 Major Dates

Study Start (Actual)

December 6, 2019

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

December 5, 2019

First Submitted That Met QC Criteria

December 5, 2019

First Posted (Actual)

December 10, 2019

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-630/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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