Clinical trial NCT03501316: The Immune Response After Periodontal Treatment
Official title: Immune Response After Periodontal Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: Root Surface Debridement
Hand Instrumentation
Ultrasonic Instrumentation
Systemic
Immune
CRP
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Analysis: the effect of treatment group (Manual vs ultrasonic) on changes in CRP levels (and other secondary outcomes):

* Appropriate generalised linear models
* Binary logistic models (for dichotomous outcomes)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Provision of signed, written, informed consent to participate
* Men or women aged 18 years to 70 years inclusive
* Periodontal disease requiring treatment at Glasgow Dental Hospital

Exclusion Criteria:

* Known or suspected high risk for tuberculosis, hepatitis B or HIV infections
* Require interpreter/non English language written material to understand and provide, or any other reason for being unable to provide written, informed consent
* History of bleeding diathesis
* Females using contraceptive methods.
* Pregnant or lactacting females.
* Reported diagnosis of any systemic illnesses including cardiovascular, renal, and liver diseases.
* Any pharmacological treatment within 3 months before the beginning of periodontal treatment.
* Specialist Periodontal treatment in the previous 6 months.
* Patients who will not tolerate Ultrasonic instrumentation even with local anaesthesia.

Primary outcomes:
measure: Serum CRP
timeFrame: 24 hours after treatment, day 7, day 90
Secondary outcomes:
measure: Microbiome
timeFrame: Pre treatment and 24 hours after treatment
measure: Bacteraemia analysis
timeFrame: Day 1, day 7, day 90 post intervention
measure: Inflammation analysis
timeFrame: Day 1, 7 and 90 post treatment
measure: Periodontal Probing depths
timeFrame: day 90
measure: Immune analysis
timeFrame: day 1, 7 and 90 post treatment
measure: Periodontal loss of attachment
timeFrame: day 90
measure: Gingivitis Index
timeFrame: day 90
measure: Plaque Index
timeFrame: day 90
measure: Blood pressure
timeFrame: day 1, 7 and 90 post treatment
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Michael Paterson
state: Glasgow City
Study officials:
affiliation: University of Glasgow
name: Shauna Culshaw
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.