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A clinical trial to compare the capability of a text message package and routine oral health education to modify the gum health and blood glucose levels of adults with Type 2 Diabetes mellitus

Phase 2
Not yet recruiting
Conditions
Chronic periodontitis, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,
Registration Number
CTRI/2023/10/058302
Lead Sponsor
Shameena V K
Brief Summary

Periodontitis and diabetes are two highly prevalent non-communicable diseases whose association has long been established. A comprehensive treatment plan incorporating a common risk factor approach which includes periodontal therapy and health education can be helpful in reducing comorbidities of diabetes. Though, traditional methods that emphasize face to face and direct education have been found to be effective, in a nation like India with a large population, mHealth intervention will be effective considering the increased rate of digitalization and mobile subscriptions. Some studies that conducted in abroad, shows effectiveness of mHealth based intervention in management of Diabetes Mellitus Type 2, to my best of knowledge there is paucity of studies conducted in India with a population of diverse characteristics and lifestyle. This study is to analyze whether integrating mHealth component for diabetes management will improve the periodontal status and diabetic status of Indian population.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Adults aged 30 years to 65 years, diagnosed with controlled Diabetes Mellitus Type 2, under regular medical therapy ( Oral hypoglycaemics /Insulin) for last 6 months.
  • Patients having chronic periodontitis having score 3 i.e. pathological pocket of 4-5 mm and Score 1 i.e. Loss of attachment 4-5mm when assessed using Community Periodontal Index 3.
  • At least 20 firm teeth with no mobility should be present.
  • Patients with access to mobile phone and with a minimum reading level of 5th grade.
  • Patients who are residing in Delhi.
Exclusion Criteria
  • Patient who are requiring periodontal surgical treatment or splint treatment.
  • Patients who underwent significant changes in diabetes medication during the study.
  • Patients with long term history of tobacco and alcohol consumption.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes in Periodontal status, Oral Hygiene status and improvement of glycaemic levels in blood glucose in intervention group.Baseline,1 month, 3 months, 6 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Lok Nayak Hospital

🇮🇳

Delhi, DELHI, India

maulana azad institute of dental sciences

🇮🇳

Delhi, DELHI, India

Lok Nayak Hospital
🇮🇳Delhi, DELHI, India
Dr Shameena V K
Principal investigator
6282640968
shami.win1@gmail.com

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