The Immune Response After Periodontal Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immune Response After Periodontal Treatment

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Device: Hand Instrumentation Treatment
* Device: Ultrasonic Instrumentation Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Analysis: the effect of treatment group (Manual vs ultrasonic) on changes in CRP levels (and other secondary outcomes): Appropriate generalised linear models Binary logistic models (for dichotomous outcomes)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hand Instrumentation<br>Root surface debridement using hand instruments. | Device: Hand Instrumentation Treatment<br>* 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.<br>|
| Active Comparator: Ultrasonic Instrumentation<br>Root surface debridement using ultrasonic scaler. | Device: Ultrasonic Instrumentation Treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Root Surface Debridement, Hand Instrumentation, Ultrasonic Instrumentation, Systemic, Immune, CRP