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Human lipidome analysis of healthy and disease gums before and after conventional treatments.

Lipidome analysis of gingival health, biofilm induced gingivitis, and stage III and IV periodontitis: A prospective clinical trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000913178
Acronym
HLA
Enrollment
75
Registered
2019-06-28
Start date
2019-07-31
Completion date
2019-09-30
Last updated
2019-07-15

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

Conditions

None listed

Brief summary

Lipids(such as resolvins) have been shown to play an important role in resolution of inflammation. The research aims to assess the lipid variations present saliva and gingival fluid of patients with no gum disease and healthy gums, compared with those with inflamed gums but no gum disease, and those with gum disease. It is expected that through the research analysis and treatment of gum disease we will identify lipid profiles amongst gum disease and health as well as certain lipid profiles that respond to treatment better than others.

Interventions

Visit 1 (Week 1): Pre-Operative Periodontal Chart by a registered dentist(Dr Akila Vithanage) who is training in Periodontics (Gum Specialist) - This provides allocation of participants into Gingival Health, Gingivitis and Periodontitis - Charting is completed with the aid of an electronic probe (FLORIDAProbe TGA APPROVED) to provide information about how much bone is lost around the teeth and how inflamed the gingiva is. - Saliva samples and Gingival Crevicular Fluid also collected at this poi

Visit 1 (Week 1): Pre-Operative Periodontal Chart by a registered dentist(Dr Akila Vithanage) who is training in Periodontics (Gum Specialist) - This provides allocation of participants into Gingival Health, Gingivitis and Periodontitis - Charting is completed with the aid of an electronic probe (FLORIDAProbe TGA APPROVED) to provide information about how much bone is lost around the teeth and how inflamed the gingiva is. - Saliva samples and Gingival Crevicular Fluid also collected at this point time. ample Collection: 1. GCF samples will be collected from each patient at each time point using an established protocol (Barros, Williams et al. 2016), where paper points (PerioCol Paper Strips, #593530, Oraflow inc.) will be inserted into the deepest pocket per tooth with minimum of two teeth examined in each sextant. 2. Saliva samples will be collected from each patient as resting saliva using SialoPaper Strips (#593528, Oraflow inc.) at each time point. 3. GCF and saliva samples will be collected and immediately stored at minus 70 degrees till the assays are to be performed. - Duration of 1 hour Visit 2 (Week 4): (Depending on what category the participant falls in, either arm 1 or arm 2 the following occurs) Arm 1: Supragingival Removal of Calculus and Dental Biofilm (Gingivitis Group) - supragingival use of hand scalars and ultra sonic scalars by a registered dentist(Dr Akila Vithanage) who is training in Periodontics (Gum Specialist) - all teeth treated for a duration of 30 minutes, single intervention - Location is Metro North Oral Health Centre, Clinic 6.1 Specialist Suites Arm 2: Non-surgical Periodontal Full Mouth Debridement (Periodontitis Group) - supragingival and subgingival use of hand scalars and ultra sonic scalars by a registered dentist(Dr Akila Vithanage) who is training in Periodontics (Gum Specialist) - all teeth treated for a duration of 2 hours, single intervention Visit 3 (Week 10): Participants will be recalled 9 weeks from the initial visit to re-assess periodontal parameters (full mouth chart) & saliva and GCF samples obtained. This will be compared to baseline measures and biomarkers will be mapped. - Duration 60 minutes Periodontal Disease patients placed into regular therapy as per the standard of care, involving routine non-surgical therapy and regular review of their gingival tissues. All participants will have a total of 3 visits expected over a period of 10 weeks. They key difference between the control group(healthy) and the disease groups is that there is no use of the ultra sonic hand scalar nor is there any subgingival instrumentation. The control group will utilise the prophylactic cup to remove plaque in a comfortable manner. Upon review of the ANZCTR commentary it appears that due to the allocation of disease category this is not a randomised trial.

Sponsors

University of Queensland
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion Criteria: - Referred into the Periodontal Clinic for implant restoration or Periodontal Therapy.

Exclusion criteria

Exclusion Criteria & Adjustable Comorbidities: - Smoking (this will be statistically adjusted and profiled according to the current periodontal grading criteria) - Uncontrolled Diabetes (this will be statistically adjusted and profiled according to the current periodontal grading criteria) - Controlled Diabetes will be deemed that of HbA1c of <6.5% (2018 ADA Definitions) at the time of data collection and will be considered the same as a non-diabetic. - Age (this will be statistically adjusted and profiled according to the current periodontal grading criteria) - Immunosuppressive Drugs (this will be statistically adjusted and profiled according to the current periodontal grading criteria) - Anti-inflammatory Drugs & Supplements (this will be statistically adjusted and profiled according to the current periodontal grading criteria) - Plaque control (this will be statistically adjusted and profiled according to the current periodontal grading criteria)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026