The Immune Response After Periodontal Treatment (iRaPT)

February 9, 2020 updated by: Michael Paterson, University of Glasgow

Immune Response After Periodontal Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G2 3JZ
        • Michael Paterson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hand Instrumentation
Root surface debridement using hand instruments.
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.
Active Comparator: Ultrasonic Instrumentation
Root surface debridement using ultrasonic scaler.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum CRP
Time Frame: 24 hours after treatment, day 7, day 90
Changes in serum CRP.
24 hours after treatment, day 7, day 90

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Glasgow

Investigators

  • Principal Investigator: Shauna Culshaw, University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

March 13, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 9, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iRaPT Research Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plans to share data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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