The Immune Response After Periodontal Treatment

Periodontal Diseases Clinical Trial

— iRaPT  

Official title:

Immune Response After Periodontal Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03501316
• Other study ID #: iRaPT Research Study
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: February 2020
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Device:
• Hand Instrumentation Treatment
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.
• Ultrasonic Instrumentation Treatment
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.

Locations

Country	Name	City	State
United Kingdom	Michael Paterson	Glasgow	Glasgow City

Sponsors (1)

Lead Sponsor	Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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. — View Citation

Heimdahl A, Hall G, Hedberg M, Sandberg H, Söder PO, Tunér 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. — View 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. Review. — View 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. — View Citation

Kinane DF, Riggio MP, Walker KF, MacKenzie D, Shearer B. Bacteraemia following periodontal procedures. J Clin Periodontol. 2005 Jul;32(7):708-13. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum CRP	Changes in serum CRP.	24 hours after treatment, day 7, day 90
Secondary	Microbiome	Microbiome analysis of plaque	Pre treatment and 24 hours after treatment
Secondary	Bacteraemia analysis	Bacteraemia analysis	Day 1, day 7, day 90 post intervention
Secondary	Inflammation analysis	Gingival Crevicular Fluid - cytokine measurements	Day 1, 7 and 90 post treatment
Secondary	Periodontal Probing depths	Periodontal Probing depths	day 90
Secondary	Immune analysis	Serum antibody measurement	day 1, 7 and 90 post treatment
Secondary	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
Secondary	Gingivitis Index	Levels of gingivitis within the oral cavity as a percentage of all tooth surfaces	day 90
Secondary	Plaque Index	Levels of plaque within the oral cavity as a percentage of all tooth surfaces	day 90
Secondary	Blood pressure	Blood pressure measured in millimeters of mercury. Measured using standard blood pressure cuff.	day 1, 7 and 90 post treatment