Michael Paterson
Glasgow, Glasgow City, G2 3JZ, United Kingdom
NCT Number: NCT03501316
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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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Glasgow, Glasgow City, G2 3JZ, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 24 hours after treatment, day 7, day 90
Changes in serum CRP.
Time frame: Pre treatment and 24 hours after treatment
Microbiome analysis of plaque
Time frame: Day 1, day 7, day 90 post intervention
Bacteraemia analysis
Time frame: Day 1, 7 and 90 post treatment
Gingival Crevicular Fluid - cytokine measurements
Time frame: day 90
Periodontal Probing depths
Time frame: day 1, 7 and 90 post treatment
Serum antibody measurement
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.
Time frame: day 90
Levels of gingivitis within the oral cavity as a percentage of all tooth surfaces
Time frame: day 90
Levels of plaque within the oral cavity as a percentage of all tooth surfaces
Time frame: day 1, 7 and 90 post treatment
Blood pressure measured in millimeters of mercury. Measured using standard blood pressure cuff.
University of Glasgow
Other
Immune Response After Periodontal Treatment
Acronym: iRaPT
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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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