The Immune Response After Periodontal Treatment

Not Applicable

Completed

• Conditions: Periodontal Diseases
• Interventions: Device: Hand Instrumentation Treatment; Device: Ultrasonic Instrumentation Treatment

• Registration Number: NCT03501316
• Lead Sponsor: University of Glasgow

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.

Study Timeline

• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-04-09
• Study First Posted: 2018-04-18
• Study Start: 2018-05-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-09-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-09
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hand Instrumentation	Hand Instrumentation Treatment	Root surface debridement using hand instruments.
Ultrasonic Instrumentation	Ultrasonic Instrumentation Treatment	Root surface debridement using ultrasonic scaler.

Primary Outcome Measures

Name	Time	Method
Serum CRP	24 hours after treatment, day 7, day 90	Changes in serum CRP.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Michael Paterson; 🇬🇧 Glasgow, Glasgow City, United Kingdom