Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000759493
Ethics application status
Approved
Date submitted
17/04/2025
Date registered
17/07/2025
Date last updated
17/07/2025
Date data sharing statement initially provided
17/07/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Diabetes Mellitus and Gum Disease link in New Zealand populations.
Scientific title
The relationship of nonsurgical periodontal management to the glycemic control of adults with uncontrolled diabetes mellitus in Maori, Pacific and New Zealand European populations.
Secondary ID [1] 314234 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periodontitis 337140 0
Diabetes Mellitus 337141 0
Condition category
Condition code
Inflammatory and Immune System 333563 333563 0 0
Connective tissue diseases
Inflammatory and Immune System 333788 333788 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Complete Periodontal Management

The Comprehensive Periodontal Management program will include the following components:

1. Oral Hygiene Instruction will be performed by the treating Specialist Periodontist, 15-20 minutes before each session (average 2-3 sessions) starts. Participants will receive thorough training on effective practices for tooth brushing, flossing, and the use of interdental brushes.
- The Oral Hygiene instructions will be performed face to face with the use of teeth models, oral hygiene aid models and direct instruction to the mouth using a handheld mirror. The amount of plaque before each session s will be measured by the use of plaque disclosing solution that is color coded to reveal the deposit in the mouth, particularly around the gingival areas. The plaque percentage will also be calculated per visit to monitor the patients improvement.

2. Full Mouth Debridement: Participants will have one to four dental appointments scheduled for full mouth debridement, each lasting 45 minutes to one hour, which may include local anesthesia. Full. mouth debridement will involve the use of an ultrasonic machine with water irrigation to efficiently remove plaque and calculus deposits around the teeth. Tracey curettes which are teeth site specific will be used to removed further deposits in hard to reach areas such as deep pockets. The number of treatment visits will be dictated by the severity of the periodontitis: 1-2 visits for mild to moderate, 3-4 visits for moderate to severe cases. All the periodontal treatment will be provided by the treating periodontal specialists. Each appointments will be logged in to the patients appointment books. The warranty of the patients having free periodontal specialist treatments is that they complete the treatments and number of appointments agreed on the first consultation visits.

3. Supportive Periodontal Therapy: This will occur at 3 and 6 months following the full mouth debridement, encompassing full mouth charting and debridement to maintain periodontal health. Additionally, serum blood levels of HbA1c will be assessed during these visits.

- Full mouth charting involved measuring all the gingival pockets around the teeth using a periodontal probe, which is a ruler that measures by millimetre. Full mouth charting will also note any areas that are still feeling and inflame and any areas that has new plaque formation. Each supportive periodontal therapy will last for 45 minutes to an hour. All the supportive periodontal therapy will be done by the treating periodontists.

4. Referral for Advanced Management: Patients requiring further periodontal management will be referred to the Postgraduate Programs at the Faculty of Dentistry. Any additional oral diagnoses necessitating further evaluation will be referred to the appropriate Dental Specialty clinics at the Faculty of Dentistry.

Intervention code [1] 330844 0
Diagnosis / Prognosis
Intervention code [2] 330845 0
Treatment: Other
Intervention code [3] 330846 0
Prevention
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341140 0
Serum Hba1C
Timepoint [1] 341140 0
Baseline HbA1c: This metric indicates the serum level of HbA1c at the time the patient was referred to the Faculty of Dentistry for periodontal management. The recorded level exceeds the stipulated threshold of 55 mmol/mol, suggesting that the diabetes is currently unstable. Serum HbA1c Level at 3 Months: The serum HbA1c level will be assessed three months following the periodontal management intervention. This measurement will allow for a comparison with the baseline HbA1c level to determine any changes. 6 Months Post Periodontal Management: A further evaluation of the serum HbA1c level will be conducted six months after the periodontal management and maintenance procedures. This assessment will provide an opportunity to compare the current level against both the baseline and the 3-month HbA1c values, thereby facilitating an analysis of the patient's ongoing progress.
Secondary outcome [1] 446480 0
Periodontal infiammatory score (PISA) of each patients
Timepoint [1] 446480 0
Periodontal Inflammatory score (PISA) at baseline, PISA at 3rd month and PISA at 6th month visits
Secondary outcome [2] 446481 0
Pocket Depth (PD) at 3rd month visit and PD at 6th month visit
Timepoint [2] 446481 0
Measurements of Pocket Depth (PD) will be conducted at: baseline, 3rd month and 6th month periodontal management visits.

Eligibility
Key inclusion criteria
The study will focus on individuals with uncontrolled diabetes (HbA1c greater than or equal to 55 mmol/mol), aged 20 to 85 years, who are non-smokers and receiving care at Dunedin Hospital Endocrinology Outpatient Clinic. The study may also expand in the future to include Southland Hospital in Invercargill, though this is outside the scope of this grant application.
Minimum age
20 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Smoker, Presence of other Systemic condition that can affect the manifestation of periodontitis, pregnant patients.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Three Groups to be assessed: Maori, Pacific and NZ of European descent groups
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample Calculation

The primary outcome of the study will be the reduction in Periodontal Inflammation Surface Area Scores (PISA). To achieve a statistical power of 90% (a equal to 5%, Type B error equal 10%) for detecting a significant 10% difference in PISA scores between groups, with an assumed standard deviation of 10%, it is determined that a total of 15 patients per group is necessary. To accommodate a projected attrition rate of 20%, 20 patients per group will be recruited, comprising at least 20 Maori, 20 Pacific, and 20 NZ European descent participants.

Statistical analyses will be performed to compare baseline HbA1c values before and after periodontal treatment, as well as differences between the 3-month and 6-month follow-ups within each group, utilizing Wilcoxon’s rank test. Data will be presented as means and standard deviations. The efficacy of treatments in reducing HbA1c levels will be compared using analysis of variance (ANOVA), followed by Tukey’s multiple comparisons. Overall differences among groups will be evaluated using two-way ANOVA, with HbA1c and PISA scores serving as the primary factors.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/04/2025
Date of last participant enrolment
Anticipated
1/09/2025
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
60
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 26983 0
New Zealand
State/province [1] 26983 0
Otago

Funding & Sponsors
Funding source category [1] 318750 0
University
Name [1] 318750 0
University of Oatgo SJWRI Sidey Fund
Country [1] 318750 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 321190 0
Government body
Name [1] 321190 0
Ministry of Health
Address [1] 321190 0
Country [1] 321190 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317365 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 317365 0
Ethics committee country [1] 317365 0
New Zealand
Date submitted for ethics approval [1] 317365 0
07/10/2024
Approval date [1] 317365 0
27/01/2025
Ethics approval number [1] 317365 0

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

Contacts
Principal investigator
Name 140818 0
A/Prof Tino Mercado
Address 140818 0
Faculty of Dentistry, University of Otago, 310 Great King St, Dunedin, Otago New Zealand 9054
Country 140818 0
New Zealand
Phone 140818 0
+64 212239191
Fax 140818 0
Email 140818 0
[email protected]
Contact person for public queries
Name 140819 0
Tino Mercado
Address 140819 0
Faculty of Dentistry, University of Otago, 310 Great King St, Dunedin, Otago New Zealand 9054
Country 140819 0
New Zealand
Phone 140819 0
+64 212239191
Fax 140819 0
Email 140819 0
[email protected]
Contact person for scientific queries
Name 140820 0
Tino Mercado
Address 140820 0
Faculty of Dentistry, University of Otago, 310 Great King St, Dunedin, Otago New Zealand 9054
Country 140820 0
New Zealand
Phone 140820 0
+64 212239191
Fax 140820 0
Email 140820 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Health and Disability Ethics Approval.pdf
Informed consent form    DM Study Patient Information Sheet Edited Feb 18, 2025.doc
OtherData and Tissue Management Plan [email protected] Data and Tissue Management Plan Final.docx


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.