The Immune Response After Periodontal Treatment (iRaPT)
Primary Purpose
Periodontal Diseases
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hand Instrumentation Treatment
Ultrasonic Instrumentation Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases focused on measuring Root Surface Debridement, Hand Instrumentation, Ultrasonic Instrumentation, Systemic, Immune, CRP
Eligibility Criteria
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.
Sites / Locations
- Michael Paterson
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hand Instrumentation
Ultrasonic Instrumentation
Arm Description
Root surface debridement using hand instruments.
Root surface debridement using ultrasonic scaler.
Outcomes
Primary Outcome Measures
Serum CRP
Changes in serum CRP.
Secondary Outcome Measures
Microbiome
Microbiome analysis of plaque
Bacteraemia analysis
Bacteraemia analysis
Inflammation analysis
Gingival Crevicular Fluid - cytokine measurements
Periodontal Probing depths
Periodontal Probing depths
Immune analysis
Serum antibody measurement
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.
Gingivitis Index
Levels of gingivitis within the oral cavity as a percentage of all tooth surfaces
Plaque Index
Levels of plaque within the oral cavity as a percentage of all tooth surfaces
Blood pressure
Blood pressure measured in millimeters of mercury. Measured using standard blood pressure cuff.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03501316
Brief Title
The Immune Response After Periodontal Treatment
Acronym
iRaPT
Official Title
Immune Response After Periodontal Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
Root Surface Debridement, Hand Instrumentation, Ultrasonic Instrumentation, Systemic, Immune, CRP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hand Instrumentation
Arm Type
Active Comparator
Arm Description
Root surface debridement using hand instruments.
Arm Title
Ultrasonic Instrumentation
Arm Type
Active Comparator
Arm Description
Root surface debridement using ultrasonic scaler.
Intervention Type
Device
Intervention Name(s)
Hand Instrumentation Treatment
Intervention Description
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
Intervention Name(s)
Ultrasonic Instrumentation Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum CRP
Description
Changes in serum CRP.
Time Frame
24 hours after treatment, day 7, day 90
Secondary Outcome Measure Information:
Title
Microbiome
Description
Microbiome analysis of plaque
Time Frame
Pre treatment and 24 hours after treatment
Title
Bacteraemia analysis
Description
Bacteraemia analysis
Time Frame
Day 1, day 7, day 90 post intervention
Title
Inflammation analysis
Description
Gingival Crevicular Fluid - cytokine measurements
Time Frame
Day 1, 7 and 90 post treatment
Title
Periodontal Probing depths
Description
Periodontal Probing depths
Time Frame
day 90
Title
Immune analysis
Description
Serum antibody measurement
Time Frame
day 1, 7 and 90 post treatment
Title
Periodontal loss of attachment
Description
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.
Time Frame
day 90
Title
Gingivitis Index
Description
Levels of gingivitis within the oral cavity as a percentage of all tooth surfaces
Time Frame
day 90
Title
Plaque Index
Description
Levels of plaque within the oral cavity as a percentage of all tooth surfaces
Time Frame
day 90
Title
Blood pressure
Description
Blood pressure measured in millimeters of mercury. Measured using standard blood pressure cuff.
Time Frame
day 1, 7 and 90 post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shauna Culshaw
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael Paterson
City
Glasgow
State/Province
Glasgow City
ZIP/Postal Code
G2 3JZ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plans to share data
Citations:
PubMed Identifier
19207889
Citation
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.
Results Reference
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PubMed Identifier
26309133
Citation
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.
Results Reference
background
PubMed Identifier
24870125
Citation
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.
Results Reference
background
PubMed Identifier
15966875
Citation
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.
Results Reference
background
PubMed Identifier
23137266
Citation
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.
Results Reference
background
PubMed Identifier
2229342
Citation
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.
Results Reference
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The Immune Response After Periodontal Treatment
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