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OpenTrials
Completed

NCT Number: NCT03501316

The 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael Paterson

Glasgow, Glasgow City, G2 3JZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Serum CRP

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

    Changes in serum CRP.

Secondary outcomes

  1. Microbiome

    Time frame: Pre treatment and 24 hours after treatment

    Microbiome analysis of plaque

  2. Bacteraemia analysis

    Time frame: Day 1, day 7, day 90 post intervention

    Bacteraemia analysis

  3. Inflammation analysis

    Time frame: Day 1, 7 and 90 post treatment

    Gingival Crevicular Fluid - cytokine measurements

  4. Periodontal Probing depths

    Time frame: day 90

    Periodontal Probing depths

  5. Immune analysis

    Time frame: day 1, 7 and 90 post treatment

    Serum antibody measurement

  6. 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.

  7. Gingivitis Index

    Time frame: day 90

    Levels of gingivitis within the oral cavity as a percentage of all tooth surfaces

  8. Plaque Index

    Time frame: day 90

    Levels of plaque within the oral cavity as a percentage of all tooth surfaces

  9. Blood pressure

    Time frame: day 1, 7 and 90 post treatment

    Blood pressure measured in millimeters of mercury. Measured using standard blood pressure cuff.

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Registry information

Official study title

Immune Response After Periodontal Treatment

Acronym: iRaPT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2018
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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