NCT03501316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

March 13, 2018

Last Update Submit

February 9, 2020

Conditions

Periodontal Diseases

Keywords

Root Surface DebridementHand InstrumentationUltrasonic InstrumentationSystemicImmuneCRP

Outcome Measures

Primary Outcomes (1)

  • Serum CRP

    Changes in serum CRP.

    24 hours after treatment, day 7, day 90

Secondary Outcomes (9)

  • Microbiome

    Pre treatment and 24 hours after treatment

  • Bacteraemia analysis

    Day 1, day 7, day 90 post intervention

  • Inflammation analysis

    Day 1, 7 and 90 post treatment

  • Periodontal Probing depths

    day 90

  • Immune analysis

    day 1, 7 and 90 post treatment

  • +4 more secondary outcomes

Study Arms (2)

Hand Instrumentation

ACTIVE COMPARATOR

Root surface debridement using hand instruments.

Device: Hand Instrumentation Treatment

Ultrasonic Instrumentation

ACTIVE COMPARATOR

Root surface debridement using ultrasonic scaler.

Device: Ultrasonic Instrumentation Treatment

Interventions

Hand Instrumentation TreatmentDEVICE

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.

Hand Instrumentation
Ultrasonic Instrumentation TreatmentDEVICE

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.

Ultrasonic Instrumentation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael Paterson

Glasgow, Glasgow City, G2 3JZ, United Kingdom

Location

Related Publications (6)

  • Ioannou I, Dimitriadis N, Papadimitriou K, Sakellari D, Vouros I, Konstantinidis A. Hand instrumentation versus ultrasonic debridement in the treatment of chronic periodontitis: a randomized clinical and microbiological trial. J Clin Periodontol. 2009 Feb;36(2):132-41. doi: 10.1111/j.1600-051X.2008.01347.x.

    PMID: 19207889BACKGROUND

  • Graziani F, Cei S, Orlandi M, Gennai S, Gabriele M, Filice N, Nisi M, D'Aiuto F. Acute-phase response following full-mouth versus quadrant non-surgical periodontal treatment: A randomized clinical trial. J Clin Periodontol. 2015 Sep;42(9):843-852. doi: 10.1111/jcpe.12451. Epub 2015 Oct 1.

    PMID: 26309133BACKGROUND

  • Horliana AC, Chambrone L, Foz AM, Artese HP, Rabelo Mde S, Pannuti CM, Romito GA. Dissemination of periodontal pathogens in the bloodstream after periodontal procedures: a systematic review. PLoS One. 2014 May 28;9(5):e98271. doi: 10.1371/journal.pone.0098271. eCollection 2014.

    PMID: 24870125BACKGROUND

  • Kinane DF, Riggio MP, Walker KF, MacKenzie D, Shearer B. Bacteraemia following periodontal procedures. J Clin Periodontol. 2005 Jul;32(7):708-13. doi: 10.1111/j.1600-051X.2005.00741.x.

    PMID: 15966875BACKGROUND

  • Zhang W, Daly CG, Mitchell D, Curtis B. Incidence and magnitude of bacteraemia caused by flossing and by scaling and root planing. J Clin Periodontol. 2013 Jan;40(1):41-52. doi: 10.1111/jcpe.12029. Epub 2012 Nov 9.

    PMID: 23137266BACKGROUND

  • Heimdahl A, Hall G, Hedberg M, Sandberg H, Soder PO, Tuner K, Nord CE. Detection and quantitation by lysis-filtration of bacteremia after different oral surgical procedures. J Clin Microbiol. 1990 Oct;28(10):2205-9. doi: 10.1128/jcm.28.10.2205-2209.1990.

    PMID: 2229342BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Shauna Culshaw

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Clinical Lecturer in Restorative Dentistry

Study Record Dates

First Submitted

March 13, 2018

First Posted

April 18, 2018

Study Start

May 1, 2018

Primary Completion

August 1, 2019

Study Completion

September 1, 2019

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

No plans to share data

Locations

GB(1)