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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-08-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

multicenter randomized controlled intervention trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

The examiner performing the measurement of all clinical periodontal parameters is not aware of the type of treatment provided to the patient.

Study Groups

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Q-SRP

Quadrant scaling and root planing

Group Type ACTIVE_COMPARATOR

Q-SRP

Intervention Type OTHER

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

FMS

Full mouth scaling and root planing

Group Type EXPERIMENTAL

FMS

Intervention Type OTHER

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

FMD

Full mouth disinfection

Group Type EXPERIMENTAL

FMD

Intervention Type OTHER

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)

FMDP

Full mouth disinfection with periopolishing

Group Type EXPERIMENTAL

FMDP

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

FMS

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

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)

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No