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

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Q-SRP
FMS
FMD
FMDP
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, full mouth scaling, air abrasion, scaling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum RWTH Aachen, Klinik für Zahnerhaltung, Parodontologie u. Präventive Zahnheilkunde
  • Charité Centrum Zahn-, Mund- und Kieferheilkunde, Parodontologie und Synoptische Zahnmedizin
  • Universitätspoliklinik für Zahnerhaltungskunde und Parodontologie
  • Universitätsmedizin Mainz, Poliklinik f. Zahnerhaltung u. Parodontologie
  • Department of Dental Medicine 1 (Periodontology)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Q-SRP

FMS

FMD

FMDP

Arm Description

Quadrant scaling and root planing

Full mouth scaling and root planing

Full mouth disinfection

Full mouth disinfection with periopolishing

Outcomes

Primary Outcome Measures

Change of clinical attachment level
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

Secondary Outcome Measures

Change of pocket probing depth
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
Change of presence of periodontopathogenic bacteria A. actinomycetemcomitans, P. gingivalis, P. intermedia and T. denticola
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
Change of bleeding on probing
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
Change of gingival index
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
Change of plaque index
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

Full Information

First Posted
March 20, 2018
Last Updated
August 27, 2020
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT03509233
Brief Title
Anti-infectious Therapy of Periodontitis - Comparison of Different Clinical Strategies
Official Title
Anti-infectious Therapy of Chronic Periodontitis Using One Stage Full Mouth Disinfection With Subgingival Airpolishing - a Comparison of Different Clinical Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 27, 2020 (Actual)
Study Completion Date
August 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RWTH Aachen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
periodontitis, full mouth scaling, air abrasion, scaling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multicenter randomized controlled intervention trial
Masking
Investigator
Masking Description
The examiner performing the measurement of all clinical periodontal parameters is not aware of the type of treatment provided to the patient.
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Q-SRP
Arm Type
Active Comparator
Arm Description
Quadrant scaling and root planing
Arm Title
FMS
Arm Type
Experimental
Arm Description
Full mouth scaling and root planing
Arm Title
FMD
Arm Type
Experimental
Arm Description
Full mouth disinfection
Arm Title
FMDP
Arm Type
Experimental
Arm Description
Full mouth disinfection with periopolishing
Intervention Type
Other
Intervention Name(s)
Q-SRP
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
FMS
Intervention Description
Full mouth scaling and rootplaning under local anesthesia using ultrasonic devices (Piezon-Master, EMS) and Gracey curettes (Hu-Friedy) within 24 hours
Intervention Type
Other
Intervention Name(s)
FMD
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
FMDP
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of clinical attachment level
Description
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
Time Frame
Baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Change of pocket probing depth
Description
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
Time Frame
Baseline, 3 months, 6 months
Title
Change of presence of periodontopathogenic bacteria A. actinomycetemcomitans, P. gingivalis, P. intermedia and T. denticola
Description
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
Time Frame
Baseline, 3 months, 6 months
Title
Change of bleeding on probing
Description
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
Time Frame
Baseline, 3 months, 6 months
Title
Change of gingival index
Description
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
Time Frame
Baseline, 3 months, 6 months
Title
Change of plaque index
Description
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
Time Frame
Baseline, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamal M. Stein, Prof. Dr.
Organizational Affiliation
Universitätsklinikum RWTH Aachen
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsklinikum RWTH Aachen, Klinik für Zahnerhaltung, Parodontologie u. Präventive Zahnheilkunde
City
Aachen
ZIP/Postal Code
52064
Country
Germany
Facility Name
Charité Centrum Zahn-, Mund- und Kieferheilkunde, Parodontologie und Synoptische Zahnmedizin
City
Berlin
ZIP/Postal Code
14197
Country
Germany
Facility Name
Universitätspoliklinik für Zahnerhaltungskunde und Parodontologie
City
Halle (Saale)
ZIP/Postal Code
06108
Country
Germany
Facility Name
Universitätsmedizin Mainz, Poliklinik f. Zahnerhaltung u. Parodontologie
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Department of Dental Medicine 1 (Periodontology)
City
Timişoara
ZIP/Postal Code
300176
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35625330
Citation
Abdelbary MMH, Schittenhelm F, Yekta-Michael SS, Reichert S, Schulz S, Kasaj A, Braun A, Conrads G, Stein JM. Impact of Three Nonsurgical, Full-Mouth Periodontal Treatments on Total Bacterial Load and Selected Pathobionts. Antibiotics (Basel). 2022 May 19;11(5):686. doi: 10.3390/antibiotics11050686.
Results Reference
derived
PubMed Identifier
35268280
Citation
Schulz S, Stein JM, Schumacher A, Kupietz D, Yekta-Michael SS, Schittenhelm F, Conrads G, Schaller HG, Reichert S. Nonsurgical Periodontal Treatment Options and Their Impact on Subgingival Microbiota. J Clin Med. 2022 Feb 23;11(5):1187. doi: 10.3390/jcm11051187.
Results Reference
derived
PubMed Identifier
34517434
Citation
Stein JM, Yekta-Michael SS, Schittenhelm F, Reichert S, Kupietz D, Dommisch H, Kasaj A, Wied S, Vela OC, Stratul SI. Comparison of three full-mouth concepts for the non-surgical treatment of stage III and IV periodontitis: A randomized controlled trial. J Clin Periodontol. 2021 Dec;48(12):1516-1527. doi: 10.1111/jcpe.13548. Epub 2021 Oct 4.
Results Reference
derived

Learn more about this trial

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

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