Anti-infectious Therapy of Periodontitis - Comparison of Different Clinical Strategies

August 27, 2020 updated by: Sareh Michael, RWTH Aachen University

Anti-infectious Therapy of Chronic Periodontitis Using One Stage Full Mouth Disinfection With Subgingival Airpolishing - a Comparison of Different Clinical Strategies

It is the aim of the study to evaluate the efficiency of "One stage full mouth disinfection" according to the original protocol (Quirynen et al. 1995) in comparison to other approaches considering different scaling strategies and different disinfection concepts. Therefore, a multicenter randomized control treatment will be performed. In total, 204 patients with chronic periodontitis shall be allocated to the following treatment concepts. Group A: quadrant scaling with weekly intervals (Q-SRP; N = 51); Group B: full mouth scaling (FMS; N = 51); Group C: full mouth disinfection (FMD; N = 51); Group D: full mouth disinfection with subgingival glycine air polishing using erythritol powder (FMDP; N = 51). Evaluation of periodontopathic parameters and periodontal pathogens at baseline, 3 months and 6 months shall give evidence about the benefits of concept and the single components of FMD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

228

Phase

  • Not Applicable

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
      • Aachen, Germany, 52064
        • Universitätsklinikum RWTH Aachen, Klinik für Zahnerhaltung, Parodontologie u. Präventive Zahnheilkunde
      • Berlin, Germany, 14197
        • Charité Centrum Zahn-, Mund- und Kieferheilkunde, Parodontologie und Synoptische Zahnmedizin
      • Halle (Saale), Germany, 06108
        • Universitätspoliklinik für Zahnerhaltungskunde und Parodontologie
      • Mainz, Germany, 55131
        • Universitätsmedizin Mainz, Poliklinik f. Zahnerhaltung u. Parodontologie
  • Romania
      • Timişoara, Romania, 300176
        • Department of Dental Medicine 1 (Periodontology)

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

Description

Inclusion Criteria:

  • patients with generalized moderate to severe chronic periodontitis
  • presence of at least 18 teeth
  • with at least 2 multi-rooted and / or 2 single-rooted teeth in the first quadrant with at least 6 sites with periodontal probing depth of ≥ 6 mm
  • radiographic bone loss of at least 25% of the root length

Exclusion Criteria:

  • subgingival scaling and root planing within the last 12 months
  • antimicrobial rinsing or intake of systemic antibiotics within the last 4 months
  • systemic diseases with known interactions to periodontal disease or known need for antibiotic prophylaxis
  • known intolerance / allergies to chlorhexidine
  • 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Q-SRP
Quadrant scaling and root planing
Other: Q-SRP
Quadrant scaling and root planing under local anesthesia using ultrasonic devices (Piezon-Master, EMS) and Gracey curettes (Hu-Friedy) within four sessions in intervals of 1 week
Experimental: FMS
Full mouth scaling and root planing
Other: FMS
Full mouth scaling and rootplaning under local anesthesia using ultrasonic devices (Piezon-Master, EMS) and Gracey curettes (Hu-Friedy) within 24 hours
Experimental: FMD
Full mouth disinfection
Other: FMD
Full mouth scaling and rootplaning under local anesthesia using ultrasonic devices (Piezon-Master, EMS) and Gracey curettes (Hu-Friedy) within 24 hours with additional disinfection using 0.2% chlorhexidine (mouth rinsing and tonsil spray), subgingival application of 1% chlorhexidine gel and 2 months postoperative home care using chlorhexidine 0.2% (rinse and spray)
Experimental: FMDP
Full mouth disinfection with periopolishing
Other: FMDP
FMD protocol (see FMD arm) with additional use of subgingival airpolishing (Air Flow, EMS) using Erythritol powder (Air-Flow Plus powder, EMS) for 20 seconds per tooth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of clinical attachment level
Time Frame: Baseline, 3 months, 6 months
Measuring the change of the distance between the cemento-enamel junction and the bottom of the periodontal pocket 3 and 6 months after therapy compared to baseline
Baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of pocket probing depth
Time Frame: Baseline, 3 months, 6 months
Measuring the change of the distance between the gingival sulcus and the bottom of the periodontal pocket 3 and 6 months after therapy compared to baseline
Baseline, 3 months, 6 months
Change of presence of periodontopathogenic bacteria A. actinomycetemcomitans, P. gingivalis, P. intermedia and T. denticola
Time Frame: Baseline, 3 months, 6 months
Analysis of pooled subgingival plaque specimen for the presence of periodontopathogenic marker bacteria A. actinomycetemcomitans, P. gingivitis, T. forsythia and P. intermedia; Assessment of the change of the occurrence of these bacteria 3 and 6 months after therapy compared to baseline
Baseline, 3 months, 6 months
Change of bleeding on probing
Time Frame: Baseline, 3 months, 6 months
Assessment of the change of the appearance of a bleeding spot immediately after the probing of periodontal pockets 3 and 6 months after therapy compared to baseline
Baseline, 3 months, 6 months
Change of gingival index
Time Frame: Baseline, 3 months, 6 months
Recording the change of the presence of supragingival plaque according to the criteria by assessment of the inflammatory status of the gingiva according to Löe et al. 3 and 6 months after therapy compared to baseline
Baseline, 3 months, 6 months
Change of plaque index
Time Frame: Baseline, 3 months, 6 months
Recording the change of the presence of supragingival plaque according to the criteria by Silness and Loe 3 and 6 months after therapy compared to baseline
Baseline, 3 months, 6 months

Collaborators and Investigators

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

Sponsor

RWTH Aachen University

Investigators

  • Study Director: Jamal M. Stein, Prof. Dr., Universitätsklinikum RWTH Aachen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2017

Primary Completion (Actual)

March 27, 2020

Study Completion (Actual)

August 27, 2020

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

April 16, 2018

First Posted (Actual)

April 26, 2018

Study Record Updates

Last Update Posted (Actual)

August 31, 2020

Last Update Submitted That Met QC Criteria

August 27, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RWTHAachenUParo01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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