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Primary Objective:
To identify changes in systemic markers of inflammation following periodontal treatment, comparing two standard treatment modalities (hands scaling and ultrasonic scaling)
Secondary Objectives:
To investigate bacteraemia, composition and function of oral bacteria, treatment outcomes following periodontal treatment, patient and operator preferences, and treatment time comparing hand scaling and ultrasonic scaling.
Effective root surface debridement (RSD) is essential for successful periodontal treatment. Myriad studies demonstrate that RSD may be carried out using hand or ulstrasonic instruments with equal efficacy. Locally, effective debridement results in reduced inflammation in the gingival tissues, ultimately preserving the dentition. Systemically, RSD results in an immediate inflammatory response with elevated C-reactive protein (CRP), and cytokines (e.g. interleukin-6 and Tumor Necrosis Factor) detectable in the serum. This systemic inflammation may relate to systemic dissemination of bacteria from the periodontal pockets into the circulation, during instrumentation. Bacteria are detectable in serum immediately after instrumentation. The incidence of the bacteraemia varies considerably between different studies, ranging from 13% of patients to 43% to 55%. These studies used different methods of instrumentation; Kinane et al used full mouth ultrasonic scale, Zhang et al used a mixture of hand and ultrasonic instruments, and Heimdahl et al used curettes only. Whilst tempting to speculate that ultrasonic instrumentation induces less bacteraemia than hand instrumentation, there is no direct comparison of the effect of ultrasonic instrumentation with hand instrumentation on post treatment systemic inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand Instrumentation | Active Comparator | Root surface debridement using hand instruments. |
|
| Ultrasonic Instrumentation | Active Comparator | Root surface debridement using ultrasonic scaler. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand Instrumentation Treatment | Device | Provision of treatment for periodontal disease using hand instrumentation. Following this, data will be collected relating to various factors, principle of which being systemic immune response. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum CRP | Changes in serum CRP. | 24 hours after treatment, day 7, day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome | Microbiome analysis of plaque | Pre treatment and 24 hours after treatment |
| Bacteraemia analysis | Bacteraemia analysis | Day 1, day 7, day 90 post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shauna Culshaw | University of Glasgow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael Paterson | Glasgow | Glasgow City | G2 3JZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19207889 | Background | Ioannou I, Dimitriadis N, Papadimitriou K, Sakellari D, Vouros I, Konstantinidis A. Hand instrumentation versus ultrasonic debridement in the treatment of chronic periodontitis: a randomized clinical and microbiological trial. J Clin Periodontol. 2009 Feb;36(2):132-41. doi: 10.1111/j.1600-051X.2008.01347.x. | |
| 26309133 | Background |
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No plans to share data
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2018 | Mar 13, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Analysis: the effect of treatment group (Manual vs ultrasonic) on changes in CRP levels (and other secondary outcomes):
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Both the patients and clinicians will remain blinded to the intervention until the intervention is carried out. Research personnel will remain blinded to specific patient allocation throughout the process through the means of patient barcodes. The key linking the barcodes to the patients will be available to the Chief Investigator. The intervention codes will only be available once the key analyses have taken place.
| Ultrasonic Instrumentation Treatment | Device | Provision of treatment for periodontal disease using ultrasonic instrumentation. Following this, data will be collected relating to various factors, principle of which being systemic immune response. |
|
| Inflammation analysis | Gingival Crevicular Fluid - cytokine measurements | Day 1, 7 and 90 post treatment |
| Periodontal Probing depths | Periodontal Probing depths | day 90 |
| Immune analysis | Serum antibody measurement | day 1, 7 and 90 post treatment |
| Periodontal loss of attachment | Index to determine the amount of connective tissue loss sustained by each tooth within the oral cavity as a result of the progressive, destructive periodontal disease process. | day 90 |
| Gingivitis Index | Levels of gingivitis within the oral cavity as a percentage of all tooth surfaces | day 90 |
| Plaque Index | Levels of plaque within the oral cavity as a percentage of all tooth surfaces | day 90 |
| Blood pressure | Blood pressure measured in millimeters of mercury. Measured using standard blood pressure cuff. | day 1, 7 and 90 post treatment |
| Graziani F, Cei S, Orlandi M, Gennai S, Gabriele M, Filice N, Nisi M, D'Aiuto F. Acute-phase response following full-mouth versus quadrant non-surgical periodontal treatment: A randomized clinical trial. J Clin Periodontol. 2015 Sep;42(9):843-852. doi: 10.1111/jcpe.12451. Epub 2015 Oct 1. |
| 24870125 | Background | Horliana AC, Chambrone L, Foz AM, Artese HP, Rabelo Mde S, Pannuti CM, Romito GA. Dissemination of periodontal pathogens in the bloodstream after periodontal procedures: a systematic review. PLoS One. 2014 May 28;9(5):e98271. doi: 10.1371/journal.pone.0098271. eCollection 2014. |
| 15966875 | Background | Kinane DF, Riggio MP, Walker KF, MacKenzie D, Shearer B. Bacteraemia following periodontal procedures. J Clin Periodontol. 2005 Jul;32(7):708-13. doi: 10.1111/j.1600-051X.2005.00741.x. |
| 23137266 | Background | Zhang W, Daly CG, Mitchell D, Curtis B. Incidence and magnitude of bacteraemia caused by flossing and by scaling and root planing. J Clin Periodontol. 2013 Jan;40(1):41-52. doi: 10.1111/jcpe.12029. Epub 2012 Nov 9. |
| 2229342 | Background | Heimdahl A, Hall G, Hedberg M, Sandberg H, Soder PO, Tuner K, Nord CE. Detection and quantitation by lysis-filtration of bacteremia after different oral surgical procedures. J Clin Microbiol. 1990 Oct;28(10):2205-9. doi: 10.1128/jcm.28.10.2205-2209.1990. |