Periodontal Diseases
Conditions
Keywords
Root Surface Debridement, Hand Instrumentation, Ultrasonic Instrumentation, Systemic, Immune, CRP
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.
Interventions
DEVICEHand 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.
DEVICEUltrasonic 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.
Sponsors
University of Glasgow
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Both the patients and clinicians will remain blinded to the intervention until the intervention is carried out. Research personnel will remain blinded to specific patient allocation throughout the process through the means of patient barcodes. The key linking the barcodes to the patients will be available to the Chief Investigator. The intervention codes will only be available once the key analyses have taken place.
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum CRP | 24 hours after treatment, day 7, day 90 | Changes in serum CRP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation analysis | Day 1, 7 and 90 post treatment | Gingival Crevicular Fluid - cytokine measurements |
| Periodontal Probing depths | day 90 | Periodontal Probing depths |
| Immune analysis | day 1, 7 and 90 post treatment | Serum antibody measurement |
| Gingivitis Index | day 90 | Levels of gingivitis within the oral cavity as a percentage of all tooth surfaces |
| Bacteraemia analysis | Day 1, day 7, day 90 post intervention | Bacteraemia analysis |
| Blood pressure | day 1, 7 and 90 post treatment | Blood pressure measured in millimeters of mercury. Measured using standard blood pressure cuff. |
| Periodontal loss of attachment | 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. |
| Microbiome | Pre treatment and 24 hours after treatment | Microbiome analysis of plaque |
| Plaque Index | day 90 | Levels of plaque within the oral cavity as a percentage of all tooth surfaces |
Countries
United Kingdom
Outcome results
None listed