| CTRI Number |
CTRI/2019/07/020444 [Registered on: 30/07/2019] Trial Registered Prospectively |
| Last Modified On: |
24/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of oral irrigator and Powered Toothbrush in Diabetics with Gum Disease. |
|
Scientific Title of Study
|
Efficacy of Subgingival Irrigation and Powered Toothbrush as Home Care Maintenance Protocol in Type-2 Diabetic patients with Active Periodontal Disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaspreet Kaur |
| Designation |
MDS Student |
| Affiliation |
Panjab University |
| Address |
Department of Periodontology Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital Sector 25 Panjab University Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9855561037 |
| Fax |
|
| Email |
jaspreetkaurbatth36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShipra Gupta |
| Designation |
Associate Professor |
| Affiliation |
Panjab University |
| Address |
Department of Periodontics Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital Sector 25 Panjab University
Chandigarh
CHANDIGARH
160014
India |
| Phone |
|
| Fax |
|
| Email |
teena1472@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Jaspreet Kaur |
| Designation |
MDS student |
| Affiliation |
Panjab University |
| Address |
Department of Periodontology Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital Sector 25 Panjab University Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9855561037 |
| Fax |
|
| Email |
jaspreetkaurbatth36@gmail.com |
|
|
Source of Monetary or Material Support
|
| Promotion of University Research and Scientific Excellance (PURSE) Grant-II Department of Science and Technology Government of India |
|
|
Primary Sponsor
|
| Name |
Dr Jaspreet kaur |
| Address |
Dr Harvansh Singh Judge Insitiute of Dental Sciences
and Hospital Panjab University Chandigarh |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jaspreet kaur |
Dr.Harvansh Singh Judge Institute of Dental Sciences and Hospital Panjab University Chandigarh |
Department of Periodontology Room No 108 First Floor Dr.Harvansh Singh Judge Institute of Dental Sciences and Hospital Sector 25 Panjab University Chandigarh
Chandigarh
CHANDIGARH |
9855561037
jaspreetkaurbatth36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee Panjab University Chandigarh (PUIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.06% Chlorhexidine mouthwash and powered toothbrush |
Sub-gingival home irrigation(oral irrigator) using 0.06% CHX twice daily along with powered toothbrush. |
| Comparator Agent |
0.12% Chlorhexidine mouthwash and manual toothbrushing. |
Mouth rinsing with 0.12% Chlorhexidine mouthwash twice daily along with manual toothbrushing. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Type 2 diabetic patients (HBA1c >7%) with generalized chronic periodontitis clinically diagnosed with the presence of pocket ≥5 mm and probing attachment loss of 4 mm or more in at least 2 different quadrants which bleed on probing .
2.Subjects who are on oral hypo-glycemic agents or insulin injections and diet in combination or separately. They should be diabetic for >1 year, are on the same type and dose of diabetic medication for the past 6 months
3.Patients who are in good physical condition and do not have any major illness or serious medical condition or transmissible disease.
4.Patients willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients with known history of allergies especially to CHX.
2.History of systemic antibiotic usage over the previous 4 months.
3.Pregnant or lactating women.
4.Non-surgical periodontal treatment within the past 6 months
5.Use of nonsteroidal anti-inflammatory drugs.
6.Use of immunosuppressive medications.
7.Subjects with intake of supplemental Ascorbic acid.
8.Subjects with history of prolonged drug use that interfere with coagulation system, e.g Coumarin derivatives.
9.History of severe cardiovascular, haematological, renal, hepatic and immunological disorders.
10.Patients who are smokers and alcoholics.
11.Patient not willing to give informed consent
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of clinical parameters in diabetic patients suffering from chronic periodontitis on home care maintenance regime comprising of twice daily sub-gingival home irrigation using 0.06% chlorhexidine gluconate along with powered toothbrushes vis a vis those on routine home care maintenance regime comprising of twice daily mouth rinsing with 0.12% chlorhexidine gluconate along with manual tooth brushes.
|
baseline
1 month
2 month
4 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparative evaluation of glycemic control between the study groups.
2. Comparative evaluation of inflammatory markers between the study groups.
3. Comparative evaluation of
microbiological profiling of the study groups.
|
baseline
4 months
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2019 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetes and Periodontitis seems to interact in bidirectional manner.The increased prevalence and severity of periodontitis seen in diabetic patients,especially in patients with poor metabolic control,has led to designation of periodontal disease as sixth complication of diabetes.Both diabetes and periodontal disease are complicating and enhancing each other magnitude and severity.It is suggested that along with medications for diabetes,the control of active periodontal infection should be essential to achieve a long term control of diabetes mellitus.Presently the standard of care for periodontitis patients with diabetes is non surgical therapy followed by surgical therapy depending on severity of disease. However this particular group of patients because of systemic complications,more often than not ,are not recommeded for elective surgery on immediate basis.Presently there is no standard protocol on which these patients should be on put until they are fit deemed for surgery.It is established that antiplaque agents may help in controlling active periodontal disease.The present study hypothesis the use of subgingival home irrigation with 0.06% chlorhexidine gluconate along with powered toothbrush , twice daily as an adjunct after supragingival scaling in type-2 diabetic patients suffering from active periodontal disease shall help in maintaining active disease free state in diabetic patients as compared to diabetic subjects on routine home care comprising of chlorhexidine gluconate rinses (0.12%) combined with manual toothbrushing twice daily. |