NCT03509233

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

3.1 years

First QC Date

March 20, 2018

Last Update Submit

August 27, 2020

Conditions

Periodontitis

Keywords

periodontitisfull mouth scalingair abrasionscaling

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline, 3 months, 6 months

Secondary Outcomes (5)

  • Change of pocket probing depth

    Baseline, 3 months, 6 months

  • Change of presence of periodontopathogenic bacteria A. actinomycetemcomitans, P. gingivalis, P. intermedia and T. denticola

    Baseline, 3 months, 6 months

  • Change of bleeding on probing

    Baseline, 3 months, 6 months

  • Change of gingival index

    Baseline, 3 months, 6 months

  • Change of plaque index

    Baseline, 3 months, 6 months

Study Arms (4)

Q-SRP

ACTIVE COMPARATOR

Quadrant scaling and root planing

Other: Q-SRP

FMS

EXPERIMENTAL

Full mouth scaling and root planing

Other: FMS

FMD

EXPERIMENTAL

Full mouth disinfection

Other: FMD

FMDP

EXPERIMENTAL

Full mouth disinfection with periopolishing

Other: FMDP

Interventions

Q-SRPOTHER

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

Q-SRP
FMSOTHER

Full mouth scaling and rootplaning under local anesthesia using ultrasonic devices (Piezon-Master, EMS) and Gracey curettes (Hu-Friedy) within 24 hours

FMS
FMDOTHER

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)

FMD
FMDPOTHER

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

FMDP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Universitätsklinikum RWTH Aachen, Klinik für Zahnerhaltung, Parodontologie u. Präventive Zahnheilkunde

Aachen, 52064, Germany

Location

Charité Centrum Zahn-, Mund- und Kieferheilkunde, Parodontologie und Synoptische Zahnmedizin

Berlin, 14197, Germany

Location

Universitätspoliklinik für Zahnerhaltungskunde und Parodontologie

Halle, 06108, Germany

Location

Universitätsmedizin Mainz, Poliklinik f. Zahnerhaltung u. Parodontologie

Mainz, 55131, Germany

Location

Department of Dental Medicine 1 (Periodontology)

Timișoara, 300176, Romania

Location

Related Publications (3)

  • 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.

    PMID: 35625330DERIVED

  • 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.

    PMID: 35268280DERIVED

  • 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.

    PMID: 34517434DERIVED

MeSH Terms

Conditions

Periodontitis

Interventions

N(3)-(4-methoxyfumaroyl)-2,3-diaminopropionic acid

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Jamal M. Stein, Prof. Dr.

    Universitätsklinikum RWTH Aachen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The examiner performing the measurement of all clinical periodontal parameters is not aware of the type of treatment provided to the patient.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: multicenter randomized controlled intervention trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

March 20, 2018

First Posted

April 26, 2018

Study Start

March 1, 2017

Primary Completion

March 27, 2020

Study Completion

August 27, 2020

Last Updated

August 31, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)DE(4)