The Immune Response After Periodontal Treatment (iRaPT)

University of Glasgow

Status

Completed

Conditions

Periodontal Diseases

Treatments

Device: Hand Instrumentation Treatment

Device: Ultrasonic Instrumentation Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03501316

iRaPT Research Study

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.