Status:
COMPLETED
Glycemic Control in T2DM Through Non-Surgical Periodontal Therapy
Lead Sponsor:
Dow University of Health Sciences
Collaborating Sponsors:
Higher Education Commission (Pakistan)
Conditions:
Chronic Periodontitis
Type 2 Diabetes Mellitus
Eligibility:
All Genders
35-65 years
Phase:
PHASE2
PHASE3
Brief Summary
It is submitted that incident and prevalent chronic periodontal infection, known as chronic periodontitis (CP) possibly has a causal relationship with diabetes mellitus (DM) having effects on HbA1c, f...
Detailed Description
The overall evidence that CP has a role in the causal pathway of DM is yet limited and inconsistent. Although intervention research has suggested that treating CP may improve glycemic control and insu...
Eligibility Criteria
Inclusion
- Age between 35 to 65 years patients suffering from moderate to severe CP at baseline and having HbA1c level ≥7% and \<10% at baseline with already diagnosed T2DM at least an year ago will be included as study sample. Moreover, those currently under oral glycemic therapy, having at least 16 natural teeth for the entire study duration and not under any definitive periodontal treatment since last 6 months of baseline visit will be considered as inclusion criteria along with no oral soft tissue lesions and those willing to sign informed consent will be considered to be recruited for this trial
Exclusion
- Pregnant or breast feeding women
- Gestational Diabetes
- Patients currently receiving dialysis
- Patients with cardiac pacemakers
- Alcoholic
- Patients with any serious concurrent disease or complication with \<1 year of life expectancy.
- Patients suffering from myelo-proliferating disorder (such as sickle cell disease) or under any such treatment that promotes a shift in the hemoglobin pattern.
- Under any anti-inflammatory drugs (daily for \>7 consecutive days) within last 2 months of baseline visit, other than low dose aspirin prescribed for Cardio-vascular disease
- Under any systemic immunosuppressive drugs like corticosteroids, cyclosporine etc.
- Under any systemic antibiotics for \>7 consecutive days within last four weeks of baseline visit.
- No medication for oral problems during last one month and during follow-up period that may affect interventions and HbA1c levels
- Any change in diabetes related medications in last 3 months of baseline visit, such as change in dose of any one hyperglycemic drug therapy by more than two-fold, addition or subtraction of an oral hypoglycemic agent or addition of insulin.
- Patients requiring any surgical (such as flap-surgery) or any non-surgical periodontal care that is restricted throughout study period depending upon the participants' group he/she may belong to.
- Patients with a history of night-grinding/ bruxism
- Patients with a history of allergic reaction with metronidazole
- Patients with mentally or/ and gross physical disability
- Failure to liaise on with the study protocol over the next 6 months
- With drawl from participation
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03343366
Start Date
January 1 2018
End Date
July 30 2020
Last Update
August 21 2020
Active Locations (1)
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1
Dow University of Health Sciences
Karachi, Sindh, Pakistan, 00000