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PeriodontitisNCT03509233

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

A study testing Q-SRP, FMS and FMD in people with Periodontitis, run by RWTH Aachen University at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Periodontitis
What is being tested?
Q-SRP, FMS and FMD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
5 sitesin 2 countries
Study dates
1 Mar 2017to 27 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Germany4 sites

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

    Aachen, 52064

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

    Berlin, 14197

  • Universitätspoliklinik für Zahnerhaltungskunde und Parodontologie

    Halle, 06108

  • Universitätsmedizin Mainz, Poliklinik f. Zahnerhaltung u. Parodontologie

    Mainz, 55131

Other trials in Germany

Romania1 site

  • Department of Dental Medicine 1 (Periodontology)

    Timișoara, 300176

Other trials in Romania

About this study

Official title: 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.

Conditions
Periodontitis
Being tested
Q-SRP, FMS, FMD, FMDP
Keywords
periodontitis, full mouth scaling, air abrasion, scaling
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • FMSOther

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

  • 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)

  • 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

Study groups in NCT03509233
Study groupRoleWhat they receive
Q-SRPActive comparatorQuadrant scaling and root planing
Receives: Other: Q-SRP
FMSExperimentalFull mouth scaling and root planing
Receives: Other: FMS
FMDExperimentalFull mouth disinfection
Receives: Other: FMD
FMDPExperimentalFull mouth disinfection with periopolishing
Receives: Other: FMDP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, 3 months, 6 months

Secondary outcomes (5)

  1. 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

    Measured: Baseline, 3 months, 6 months

  2. 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

    Measured: Baseline, 3 months, 6 months

  3. 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

    Measured: Baseline, 3 months, 6 months

  4. 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

    Measured: Baseline, 3 months, 6 months

  5. 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

    Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2018
  2. Study start1 Mar 2017
  3. Primary completion27 Mar 2020
  4. Study completion27 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
multicenter randomized controlled intervention trial
Masking
Single blind
Who is masked
Investigator
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03509233
Sponsor's protocol ID
RWTHAachenUParo01
Status last verified
Aug 2020
First submitted
20 Mar 2018
Last updated
31 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35625330

  • 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.

    PubMed 35268280

  • 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.

    PubMed 34517434

Questions about this trial

What is this clinical trial studying?

A study testing Q-SRP, FMS and FMD in people with Periodontitis, run by RWTH Aachen University at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of clinical attachment level (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03509233, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.

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