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

R

RWTH Aachen University

Status

Completed

Conditions

Periodontitis

Treatments

Other: FMD
Other: FMDP
Other: FMS
Other: Q-SRP

Study type

Interventional

Funder types

Other

Identifiers

NCT03509233
RWTHAachenUParo01

Details and patient eligibility

About

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.

Enrollment

228 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

228 participants in 4 patient groups

Q-SRP
Active Comparator group
Description:
Quadrant scaling and root planing
Treatment:
Other: Q-SRP
FMS
Experimental group
Description:
Full mouth scaling and root planing
Treatment:
Other: FMS
FMD
Experimental group
Description:
Full mouth disinfection
Treatment:
Other: FMD
FMDP
Experimental group
Description:
Full mouth disinfection with periopolishing
Treatment:
Other: FMDP

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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