| CTRI Number |
CTRI/2023/10/058302 [Registered on: 05/10/2023] Trial Registered Prospectively |
| Last Modified On: |
26/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
Effectiveness of M-Health Intervention versus Conventional Oral Health Education on Periodontal Status and Glycaemic control among Adults with Diabetes Mellitus Type 2: A Randomized Control Trial. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shameena V K |
| Designation |
Post Graduate student, MDS |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room No.504
Department of Public Health Dentistry
Maulana Azad Institute of Dental Sciences
BahadurshahZafar MArg,MAMC campus,NewDelhi
New Delhi
DELHI
110002
India |
| Phone |
6282640968 |
| Fax |
|
| Email |
shami.win1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vikrant Mohanty |
| Designation |
Professor and Head of the Department, Public Health Dentistry |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry
Maulana Azad Institute of Dental Sciences
BahadurshahZafar MArg,MAMC campus,NewDelhi
New Delhi
DELHI
110002
India |
| Phone |
9654700983 |
| Fax |
|
| Email |
vikrantmohanty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shameena V K |
| Designation |
Post Graduate student, MDS |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room No.504
Department of Public Health Dentistry
Maulana Azad Institute of Dental Sciences
BahadurshahZafar MArg,MAMC campus,NewDelhi
New Delhi
DELHI
110002
India |
| Phone |
6282640968 |
| Fax |
|
| Email |
shami.win1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulna Azad Institute of Dental Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Shameena V K |
| Address |
Maulana Azad Institute of Dental Sciences
Bahadurshah zafar marg
MAMC Campus, New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shameena V K |
Lok Nayak Hospital |
Diabetes clinic, 3rd floor, Room number :316,Jawaharlal Nehru Marg, near Delhi gate
New Delhi
DELHI |
6282640968
shami.win1@gmail.com |
| Dr Shameena V K |
maulana azad institute of dental sciences |
Room number 504,Department of Public Health Dentistry,
MAMC complex, Bahadurshah zafar marg.
New Delhi
DELHI |
6282640968
shami.win1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maulana Azad Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional health education
|
1. Periodontal therapy (Scaling) will be performed at baseline by removal of supragingival deposits (plaque and calculus) using an ultrasonic scaler.
2. Oral health education (Physically administered for about 10 minutes in hindi language regarding oral health care in diabetic management)
3. Oral hygiene advice (Modified Bass brushing technique physically demonstrated using a brushing model and in Hindi language)
4. Oral hygiene instructions including brushing twice daily with Modified Bass brushing technique once daily, advising warm saline gargle will be advised and other oral hygiene aids that tailor made according to patient’s clinical condition will be provided .
|
| Intervention |
mHealth package |
Validated text messages based on Health Belief Model of behavioural change for target population delivered at a time interval of twice a week, including welcome message addressing the investigator team and inviting to the programme for a duration of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. 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.
2. 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.
4. Patients with access to mobile phone and with a minimum reading level of 5th grade.
5. Patients who are residing in Delhi.
|
|
| ExclusionCriteria |
| Details |
1. Patient who are requiring periodontal surgical treatment or splint treatment.
2. Patients who underwent significant changes in diabetes medication during the study.
3. Patients with long term history of tobacco and alcohol consumption
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/11/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |