AzTrials
AzTrials

Periodontal DiseasesiRaPTNCT03501316

The Immune Response After Periodontal Treatment

A study testing Hand Instrumentation Treatment and Ultrasonic Instrumentation Treatment in people with Periodontal Diseases, run by University of Glasgow at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Periodontal Diseases
What is being tested?
Hand Instrumentation Treatment and Ultrasonic Instrumentation Treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited Kingdom
Study dates
1 May 2018to 1 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Michael Paterson

    Glasgow, Glasgow City, G2 3JZ

Other trials in United Kingdom

About this study

Official title: Immune Response After Periodontal Treatment

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.

Read the 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.

Being tested
Hand Instrumentation Treatment, Ultrasonic Instrumentation Treatment
Keywords
Root Surface Debridement, Hand Instrumentation, Ultrasonic Instrumentation, Systemic, Immune, CRP
Medical subject headings
Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT03501316
Study groupRoleWhat they receive
Hand InstrumentationActive comparatorRoot surface debridement using hand instruments.
Receives: Device: Hand Instrumentation Treatment
Ultrasonic InstrumentationActive comparatorRoot surface debridement using ultrasonic scaler.
Receives: Device: Ultrasonic Instrumentation Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum CRP

    Changes in serum CRP.

    Measured: 24 hours after treatment, day 7, day 90

Secondary outcomes (9)

  1. Microbiome

    Microbiome analysis of plaque

    Measured: Pre treatment and 24 hours after treatment

  2. Bacteraemia analysis

    Bacteraemia analysis

    Measured: Day 1, day 7, day 90 post intervention

  3. Inflammation analysis

    Gingival Crevicular Fluid - cytokine measurements

    Measured: Day 1, 7 and 90 post treatment

  4. Periodontal Probing depths

    Periodontal Probing depths

    Measured: day 90

  5. Immune analysis

    Serum antibody measurement

    Measured: day 1, 7 and 90 post treatment

  6. Periodontal loss of attachment

    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.

    Measured: day 90

  7. Gingivitis Index

    Levels of gingivitis within the oral cavity as a percentage of all tooth surfaces

    Measured: day 90

  8. Plaque Index

    Levels of plaque within the oral cavity as a percentage of all tooth surfaces

    Measured: day 90

  9. Blood pressure

    Blood pressure measured in millimeters of mercury. Measured using standard blood pressure cuff.

    Measured: day 1, 7 and 90 post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2018
  2. Study start1 May 2018
  3. Primary completion1 Aug 2019
  4. Study completion1 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03501316
Sponsor's protocol ID
iRaPT Research Study
Acronym
iRaPT
Status last verified
Feb 2020
First submitted
13 Mar 2018
Last updated
11 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plans to share data

Publications

  • 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.

    PubMed 19207889

  • 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.

    PubMed 26309133

  • 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.

    PubMed 24870125

  • 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.

    PubMed 15966875

  • 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.

    PubMed 23137266

  • 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.

    PubMed 2229342

  • Simpson A, Johnston W, Carda-Dieguez M, Mira A, Easton C, Henriquez FL, Culshaw S, Rosier BT, Burleigh M. Periodontal treatment causes a longitudinal increase in nitrite-producing bacteria. Mol Oral Microbiol. 2024 Dec;39(6):491-506. doi: 10.1111/omi.12479. Epub 2024 Aug 22.

    PubMed 39169836

Questions about this trial

What is this clinical trial studying?

A study testing Hand Instrumentation Treatment and Ultrasonic Instrumentation Treatment in people with Periodontal Diseases, run by University of Glasgow at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum CRP (time frame: 24 hours after treatment, day 7, day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03501316, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in