The Immune Response After Periodontal Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-09-01

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.

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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.

Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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Hand Instrumentation

Root surface debridement using hand instruments.

Group Type ACTIVE_COMPARATOR

Hand Instrumentation Treatment

Intervention Type 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

Root surface debridement using ultrasonic scaler.

Group Type ACTIVE_COMPARATOR

Ultrasonic Instrumentation Treatment

Intervention Type 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.

Interventions

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Hand 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.

Intervention Type DEVICE

Ultrasonic 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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes