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Diabetes Mellitus and Gum Disease link in New Zealand populations.

The relationship of nonsurgical periodontal management to the glycemic control of adults with uncontrolled diabetes mellitus in Maori, Pacific and New Zealand European populations.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000759493
Enrollment
3
Registered
2025-07-17
Start date
2025-04-01
Completion date
2025-09-01
Last updated
2025-09-08

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 study will evaluate if the management of gum diseases of patients with uncontrolled type 2 diabetes mellitus, will help in the stability of their diabetes mellitus. The diabetes mellitus stability level will be measured by blood serum level of HbA1c. This study will evaluate the relationship between the clinical severity of periodontal disease—measured through Periodontal Inflammation Surface Area (PISA), probing depth (PD), and clinical attachment loss (CAL),—and diabetes mellitus (DM) within New Zealand populations of Maori, Pacific, and European descent. It will also investigate whether the anticipated improvements in PISA and PD following non-surgical periodontal therapy (NST) correlate with the changes in HbA1c measurements of diabetes management at the 3 and 6 months post-treatment.

Interventions

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 mode

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.

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
20 Years to 85 Years
Healthy volunteers
No

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.

Exclusion criteria

Smoker, Presence of other Systemic condition that can affect the manifestation of periodontitis, pregnant patients.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026