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Effect of periodontitis treatment on histone deacetylase expression levels : a prospective clinical study.

Effect of periodontitis treatment on histone deacetylase expression levels in patients with periodontal disease: a prospective clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621000244808
Acronym
HDEP
Enrollment
40
Registered
2021-03-08
Start date
2021-04-09
Completion date
2021-12-12
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This pilot study aims to reveal the profiles of histone deacetylase (HDAC) in healthy, gingivitis, periodontitis and periodontitis treatment follow-up (3, 6 and 12 months)..There are three aims for this project: Aim 1: Diagnosis Compare the differences in Class I and II HDAC gene expression between health, gingivitis and periodontitis Aim 2: Prognosis Evaluate any correlations between changes in HDAC expression and response to periodontal treatment over a 1-year observation period. Aim 3: Non-responding sites To evaluate the HDAC activity in non-responding sites (identified at the first review) and follow changes in these sites over the remaining 9 months. It is hypothesised that HDACs are differentially expressed in periodontitis patients compared with healthy and gingivitis patients, and correlates with the severity of periodontitis. Furthermore, it is hypothesised that HDAC levels will be positively correlated with improvements in clinical parameters after periodontal treatment. After conducting a scoping review of the existing literature, the vast majority of studies assess epigenetic profiles of periodontitis vs healthy tissues based on a cross-sectional snapshot. As periodontitis is a dynamic inflammatory disease fueled by dysbiosis, with widely varying periods of remission and exacerbation, cross-sectional epigenetic studies provide limited insight into disease onset and progressive over time from the host perspective (Goodson et al 1982). Most of the existing human studies governing this topic have collected gingival biopsies from periodontitis patients, however this may deter patient acceptance and invalidate sample reproducibility, particularly for repeated sample collections over a follow-up period (Alminana-Pastor et al 2019). Other less invasive and easily accessible DNA sources such as gingival crevicular fluid and saliva could be considered as a clinically feasible diagnostic tool for targeted epigenetic analysis (Nishitani et al 2018). Another noticeable gap in the literature is the lack of human studies conducted on histone modification changes in the periodontal tissues, with current research focused on animal and in-vitro studies. Thus, to our knowledge, this is the first prospective longitudinal study to assess epigenetic histone modifications in human periodontitis and in response to periodontal therapy. Overall, the results of this study hope to identify which HDACs could be differentially expressed in periodontitis patients, and if changes in the epigenome correlate with treatment response. This could provide preliminary data for epigenetic marks as a diagnostic biomarker to detect non-responders, and also epi-drug HDAC inhibitor targets for treating periodontitis.

Interventions

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 h

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.

Sponsors

University of Queensland
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
35 Years to No maximum
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026