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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Q-SRP | Active Comparator | Quadrant scaling and root planing |
|
| FMS | Experimental | Full mouth scaling and root planing |
|
| FMD | Experimental | Full mouth disinfection |
|
| FMDP | Experimental | Full mouth disinfection with periopolishing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Q-SRP | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 3 months, 6 months |
| Change of presence of periodontopathogenic bacteria A. actinomycetemcomitans, P. gingivalis, P. intermedia and T. denticola |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamal M. Stein, Prof. Dr. | Universitätsklinikum RWTH Aachen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum RWTH Aachen, Klinik für Zahnerhaltung, Parodontologie u. Präventive Zahnheilkunde | Aachen | 52064 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35625330 | Derived | 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. | |
| 35268280 | Derived |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C056276 | N(3)-(4-methoxyfumaroyl)-2,3-diaminopropionic acid |
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multicenter randomized controlled intervention trial
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The examiner performing the measurement of all clinical periodontal parameters is not aware of the type of treatment provided to the patient.
| FMS | Other | Full mouth scaling and rootplaning under local anesthesia using ultrasonic devices (Piezon-Master, EMS) and Gracey curettes (Hu-Friedy) within 24 hours |
|
| FMD | 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 | 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 |
|
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 |
| Baseline, 3 months, 6 months |
| 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 | Baseline, 3 months, 6 months |
| 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 | Baseline, 3 months, 6 months |
| 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 | Baseline, 3 months, 6 months |
| Charité Centrum Zahn-, Mund- und Kieferheilkunde, Parodontologie und Synoptische Zahnmedizin |
| Berlin |
| 14197 |
| Germany |
| Universitätspoliklinik für Zahnerhaltungskunde und Parodontologie | Halle | 06108 | Germany |
| Universitätsmedizin Mainz, Poliklinik f. Zahnerhaltung u. Parodontologie | Mainz | 55131 | Germany |
| Department of Dental Medicine 1 (Periodontology) | Timișoara | 300176 | Romania |
| 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. |
| 34517434 | Derived | 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. |