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Clinical Trials/NCT03501316
NCT03501316
Completed
Not Applicable

Immune Response After Periodontal Treatment

University of Glasgow1 site in 1 country42 target enrollmentMay 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontal Diseases
Sponsor
University of Glasgow
Enrollment
42
Locations
1
Primary Endpoint
Serum CRP
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
September 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Paterson

Honorary Clinical Lecturer in Restorative Dentistry

University of Glasgow

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.

Outcomes

Primary Outcomes

Serum CRP

Time Frame: 24 hours after treatment, day 7, day 90

Changes in serum CRP.

Secondary Outcomes

  • Immune analysis(day 1, 7 and 90 post treatment)
  • Periodontal Probing depths(day 90)
  • Periodontal loss of attachment(day 90)
  • Bacteraemia analysis(Day 1, day 7, day 90 post intervention)
  • Plaque Index(day 90)
  • Blood pressure(day 1, 7 and 90 post treatment)
  • Microbiome(Pre treatment and 24 hours after treatment)
  • Inflammation analysis(Day 1, 7 and 90 post treatment)
  • Gingivitis Index(day 90)

Study Sites (1)

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