Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000244808
Ethics application status
Approved
Date submitted
30/12/2020
Date registered
8/03/2021
Date last updated
17/02/2022
Date data sharing statement initially provided
8/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of periodontitis treatment on histone deacetylase expression levels : a prospective clinical study.
Scientific title
Effect of periodontitis treatment on histone deacetylase expression levels in patients with periodontal disease: a prospective clinical study
Secondary ID [1] 303083 0
Nil known
Universal Trial Number (UTN)
U1111-1263-1613
Trial acronym
HDEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periodontitis 320158 0
Gingivitis 320159 0
Condition category
Condition code
Oral and Gastrointestinal 318102 318102 0 0
Normal oral and gastrointestinal development and function
Oral and Gastrointestinal 318103 318103 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
o Baseline and initial treatment visit (0-month; 1 hour duration)
o Pre-operative periodontal charting recorded by Dr Andrew Liaw (Periodontics registrar) using a calibrated probe (FLORIDAProbe)
o This will allocate participants into the group categories: periodontal health, gingivitis and periodontitis
o Saliva and gingival crevicular fluid (GCF) samples will be collected from all patients
- For saliva collection: participants will be asked to refrain from eating and drinking for at least one hour prior to saliva sample collection. At the appointment, participants will rinse their mouth with ~10 mL of water to remove the food debris. Unstimulated whole saliva through spitting (3mL ideally; minimum 1-1.5ml) will be collected
- GCF will be collected prior to commencing treatment to avoid contamination via blood. This will be conducted using an established protocol (Barros et al 2016) where paper strips (Oraflow) will be inserted into the deepest site of each quadrant (to reduce saliva contamination) and pooled.
- For healthy patients: 1 paper strip will be collected each from 2 healthy sites (free of inflammation and BOP) from the same tooth and pooled.
- For gingivitis patients: 2 paper strips will be collected from 1 inflamed site (or 2 sites from the same tooth)
- For periodontitis patients: 2 paper strips will be collected each from 1 deepest site and 1 healthy site
o GCF and saliva samples will be stored immediately at -80 degrees at the Research Lab, Level 6, Oral Health Centre, until elution and extraction.

Patients in the periodontitis group will be allocated the next available appointment for standard care, receiving supragingival and subgingival non-surgical debridement using hand scalers and ultrasonic instruments over 2 appointments (60-90 mins duration per appointment).

Follow-up reviews (3- and 6-mo post-periodontal treatment; 1 hour duration)
o Periodontitis patients will be recalled 3 mo following debridement to re-assess periodontal parameters and recollect saliva and GCF (from the same sites as baseline appointment)
o They will then receive the standard protocol of care, including oral hygiene instruction (OHI), non-surgical re-instrumentation of persistent sites and supragingival maintenance of remaining sites.
o Patients will then be recalled at the 6 mo time point (since initial therapy)
o Patient compliance to treatment reviews will be recorded using a clinic attendance checklist.
Intervention code [1] 319378 0
Diagnosis / Prognosis
Intervention code [2] 319379 0
Early Detection / Screening
Comparator / control treatment
Those in the gingival health and gingivitis group will receive one round of full mouth debridement at the next available appointment over 1 session, followed up at 6 mo, where they will have their charting, saliva and GCF recollected. Their compliance to treatment reviews will be recorded using a clinic attendance checklist.
Control group
Active

Outcomes
Primary outcome [1] 326091 0
Levels of histone deacetylase (HDAC) mRNA expression in saliva and GCF, measured using qPCR
Timepoint [1] 326091 0
0 mo pre-periodontal therapy, and 3 and 6 mo post-periodontal therapy
Secondary outcome [1] 390095 0
Change in probing pocket depth (PPD), measured using a calibrated periodontal probe (Florida Probe).
Timepoint [1] 390095 0
0 mo pre-periodontal therapy, and 3 and 6 mo post-periodontal therapy
Secondary outcome [2] 392348 0
Change in clinical attachment level (CAL), measured using a calibrated periodontal probe (Florida Probe).
Timepoint [2] 392348 0
0 mo pre-periodontal therapy, and 3 and 6 mo post-periodontal therapy
Secondary outcome [3] 392349 0
Change in bleeding on probing (BOP), measured using a calibrated periodontal probe (Florida Probe).
Timepoint [3] 392349 0
0 mo pre-periodontal therapy, and 3 and 6 mo post-periodontal therapy
Secondary outcome [4] 392350 0
Change in plaque index (PI), measured using a calibrated periodontal probe (Florida Probe).
Timepoint [4] 392350 0
0 mo pre-periodontal therapy, and 3 and 6 mo post-periodontal therapy
Secondary outcome [5] 392351 0
Change in no. of residual sites with PPD >=5mm), measured using a calibrated periodontal probe (Florida Probe).
Timepoint [5] 392351 0
0 mo pre-periodontal therapy, and 3 and 6 mo post-periodontal therapy

Eligibility
Key inclusion criteria
Patients 35 years of age or older.

For the periodontal health group:
No history of Stage III and IV periodontitis. BOP<10% and PPD<=3mm

For the gingivitis group*:
>=30% BOP and PPD<=3mm

For the periodontitis group*:
Generalised Stage III and IV Periodontitis, defined by:
>=30% sites with interdental CAL of at least 1-2mm and radiographic bone loss.
Interdental CAL >=5mm
Radiographic bone loss extending to middle third of root and beyond
Tooth loss due to periodontitis
Probing depths >=6mm
Class II or III furcation involvement

*Based on Chapple et al 2018
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current smokers
Uncontrolled diabetes (HbA1c>=6.5)*
Long-term use of immunosuppressive or anti-inflammatory drugs, periodontal treatment or antibiotics therapy six months prior to investigation
*Based on American Diabetes Association 2018

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
• For descriptive analysis of categorical data, absolute and relative frequencies will be calculated. The numerical data will be first assessed for approximate normality. Chi-square tests and one-way ANOVA will be used for inferential analysis comparing the demographic data and outcome characteristics at baseline. Data will be displayed in a table form.

• To take into account correlations within subjects, random-intercept linear regression models will be applied to evaluate histone deacetylases changes over time in the periodontitis group, gingivitis group and healthy group, separately. This will be displayed in the form of a line graph showing trends over time.

• The significance of differences (expression level of HDACs) between study groups (healthy, gingivitis, periodontitis) at each time-point will be assessed using one-way ANOVA and Kruskal-Walls tests.

• The significance of differences within pairs of groups over certain time points will be assessed using paired Friedman test followed by post-tests.

• Confidence interval 95% with p value < 0.05.

• Multi-variate analyses using will be conducted to adjust for confounders (smoking, plaque control, age, sex, ethnicity) and subanalysis of different staging of periodontitis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
9/04/2021
Actual
9/04/2021
Date of last participant enrolment
Anticipated
1/09/2021
Actual
12/12/2021
Date of last data collection
Anticipated
1/04/2022
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 307486 0
University
Name [1] 307486 0
School of Dentistry - University of Queensland
Country [1] 307486 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Dentistry
288 Herston Road
Corner Bramston Tce and Herston Rd
Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 308162 0
None
Name [1] 308162 0
Address [1] 308162 0
Country [1] 308162 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307560 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 307560 0
Ethics committee country [1] 307560 0
Australia
Date submitted for ethics approval [1] 307560 0
05/06/2019
Approval date [1] 307560 0
09/07/2019
Ethics approval number [1] 307560 0
54584
Ethics committee name [2] 307561 0
University of Queensland Human Research Ethics Committee B
Ethics committee address [2] 307561 0
Ethics committee country [2] 307561 0
Australia
Date submitted for ethics approval [2] 307561 0
18/06/2018
Approval date [2] 307561 0
12/11/2018
Ethics approval number [2] 307561 0
2018001225

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107678 0
Dr Andrew Liaw
Address 107678 0
University of Queensland
Metro North Oral Health Clinic
6.1 Specialist Suites
Oral Health Centre, 288 Herston Road
Corner Bramston Terrace and Herston Road
Herston QLD 4006, Australia
Country 107678 0
Australia
Phone 107678 0
+61487547145
Fax 107678 0
Email 107678 0
[email protected]
Contact person for public queries
Name 107679 0
Andrew Liaw
Address 107679 0
University of Queensland
Metro North Oral Health Clinic
6.1 Specialist Suites
Oral Health Centre, 288 Herston Road
Corner Bramston Terrace and Herston Road
Herston QLD 4006, Australia
Country 107679 0
Australia
Phone 107679 0
+61487547145
Fax 107679 0
Email 107679 0
[email protected]
Contact person for scientific queries
Name 107680 0
Andrew Liaw
Address 107680 0
University of Queensland
Metro North Oral Health Clinic
6.1 Specialist Suites
Oral Health Centre, 288 Herston Road
Corner Bramston Terrace and Herston Road
Herston QLD 4006, Australia
Country 107680 0
Australia
Phone 107680 0
+61487547145
Fax 107680 0
Email 107680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.