| CTRI Number |
CTRI/2023/09/057256 [Registered on: 05/09/2023] Trial Registered Prospectively |
| Last Modified On: |
28/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of Electrical Stimulation Effect With and Without Ginger Mouthwash in Sugar Patients with Low Saliva Secretion |
|
Scientific Title of Study
|
Comparative Evaluation of Transcutaneous Electrical Nerve Stimulation With and Without Ginger Mouth wash in Type II Diabetes Mellitus Patients With Hyposalivation - A Clinical Trail |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sasipriyadarsini |
| Designation |
Post Graduate student second year |
| Affiliation |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
Karpaga Vinayaga institute of dental sciences,
Department of Oral Medicine and radiology,
Room No: 4, Ground floor,
Chinna Kolambakkam, Madhuranthagam Taluk, Palayanoor post, Chengalpattu.
Karpaga Vinayaga institute of dental sciences,
Department of Oral Medicine and radiology,
Room No: 4, Ground floor,
Chinna Kolambakkam, Madhuranthagam Taluk, Palayanoor post, Chengalpattu.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
6382161347 |
| Fax |
- |
| Email |
sasipriyadharsini1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R R Mahendra Raj |
| Designation |
Senior Professor and Head of the Department |
| Affiliation |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
Karpaga Vinayaga institute of dental sciences,
Department of Oral Medicine and radiology,
Room No: 4, Ground floor,
Chinna Kolambakkam, Madhuranthagam Taluk, Palayanoor post, Chengalpattu.
Karpaga Vinayaga institute of dental sciences,
Department of Oral Medicine and radiology,
Room No: 4, Ground floor,
Chinna Kolambakkam, Madhuranthagam Taluk, Palayanoor post, Chengalpattu.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9789055848 |
| Fax |
- |
| Email |
drmahendraraj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R R Mahendra Raj |
| Designation |
Senior Professor and Head of the Department |
| Affiliation |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
Karpaga Vinayaga institute of dental sciences,
Department of Oral Medicine and Radiology,
Room No: 4, Ground floor,
Chinna Kolambakkam, Madhuranthagam Taluk, Palayanoor post, Chengalpattu.
Karpaga Vinayaga institute of dental sciences,
Department of Oral Medicine and Radiology,
Room No: 4, Ground floor,
Chinna Kolambakkam, Madhuranthagam Taluk, Palayanoor post, Chengalpattu.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9789055848 |
| Fax |
- |
| Email |
drmahendraraj@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Karpaga Vinayaga Institute of Dental Sciences,
Department of Oral Medicine and Radiology,
Room no 4, Ground floor,
Division of dental hospital road,
Chinna Kolambakkam, Madhuranthagam Taluk, Palayanoor post, Chengalpattu - 603308. |
|
|
Primary Sponsor
|
| Name |
Sasipriyadarsini |
| Address |
Karpaga Vinayaga institute of dental sciences,
Department of Oral Medicine and radiology,
Room No: 4, Ground floor,
Chinna Kolambakkam, Madhuranthagam Taluk, Palayanoor post, Chengalpattu. |
| 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 |
| Dr Sasipriyadarsini |
Karpaga Vinayaga Institute of Dental Sciences |
Karpaga Vinayaga Institute of Dental Sciences,
Department of Oral Medicine and Radiology,
Room no 4, Ground floor,
Division of dental hospital road,
Chinna Kolambakkam, Madhuranthagam Taluk, Palayanoor post, Chengalpattu - 603308.
Kancheepuram
TAMIL NADU |
6382161347
-
sasipriyadharsini1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee -Karpaga Vinayaga Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K117||Disturbances of salivary secretion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ginger Mouthwash and Distilled Water |
For Group 1: On 1st day, Unstimulated saliva is collected. Transcutaneous Electrical Nerve Stimulation is applied for 5mins over the parotid gland bilaterally and stimulated saliva is collected in calibrated cups. Transcutaneous Electrical Nerve Stimulation will be given on Follow up visits on the 7th day, 14th day, and 21st day. Patients are advised to use ginger mouthwash (0.5 g/250 mL) thrice a day throughout the study. On the 28th day, we are going to evaluate the salivary levels after 4 settings of Transcutaneous Electrical Nerve Stimulation along with ginger mouthwash usage
For Group 2: On 1st day, Unstimulated saliva is collected. Transcutaneous Electrical Nerve Stimulation is applied for 5mins over the parotid gland bilaterally and stimulated saliva is collected in calibrated cups. Transcutaneous Electrical Nerve Stimulation will be given on Follow up visits on the 7th day, 14th day, and 21st day. Patients are advised to use distilled water (250mL) as a mouthwash thrice a day throughout the study. On the 28th day, we are going to evaluate the salivary levels after 4 settings of Transcutaneous Electrical Nerve Stimulation along with distilled water usage
|
| Intervention |
Transcutaneous Electrical Nerve Stimulation |
For Group 1 and Group 2 patient: On 1st day, Unstimulated saliva is collected and Transcutaneous Electrical Nerve Stimulation is applied for 5mins over the parotid gland bilaterally and stimulated saliva is collected in calibrated cups.
Transcutaneous Electrical Nerve Stimulation will be given on Follow up visits on the 7th day, 14th day, and 21st day.
On the 28th day, we are going to evaluate the salivary levels after 4 sittings of Transcutaneous Electrical Nerve Stimulation |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
40-65 years age group of patients
Patients with fasting blood glucose level > 126mg/dl
Patients undertaking diabetic medication
Non-smokers
Non-alcoholic |
|
| ExclusionCriteria |
| Details |
Individuals with pacemakers, defibrillators, hearing aids, and cochlear implants
Individuals with salivary gland disease, endocrine disease, and psychogenic disease
Neurologic disorders like stroke, parkinsonism, bell’s palsy, asthma, and epilepsy
Pregnant women
Individuals with systemic & autoimmune disease
Individuals on medications (which produce dry mouth)
Individuals on medications for salivary secretion improvement
Radiation therapy undergone individuals for head & neck cancer
Individuals with contact dermatitis
Individuals who are allergic to ginger
Individuals with adverse habits like smoking, tobacco & areca nut
|
|
|
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 |
| Comparing the effectiveness of TENS With & Without Ginger Mouthwash in both Groups |
Two months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the salivary flow rates in group 1 patients with hyposalivation undertaking ginger mouthwash & TENS therapy
To estimate the salivary flow rates in group 2 patients with hyposalivation undertaking distilled water and TENS therapy
|
Two months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
11/09/2023 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Saliva plays a critical role in maintaining oral homeostasis. A decrease in salivary function, known as xerostomia, increases a patient’s risk for caries and other oral infections. Palliative management of xerostomia includes wetting agents such as ice chips, drugs, and saliva substitutes. Systemic agents stimulate salivary flow but often have unfavorable side effects. Modalities like Transcutaneous electric Nerve Stimulation, which has fewer side effects have been used to stimulate salivary flow. The rhizome Zingiber officinale Roscoe, known as ginger, has been used as a spice for over 2000 years. Various authors suggest that ginger has a potential effect in increasing the salivary flow rate. It is considered a safe food by US Food and Drug Administration (FDA) AIM The aim of this study is to evaluate the effect of Transcutaneous Electric Nerve Stimulation along with ginger mouthwash on the salivary flow rates of type 2 diabetes mellitus patients with reduced salivary secretion OBJECTIVES To estimate the salivary flow rate before and after ginger mouthwash usage in type 2 diabetes mellitus patients with reduced salivary secretion To estimate the unstimulated whole salivary flow rate before Transcutaneous Electric Nerve Stimulation therapy and the stimulated whole salivary flow rate after Transcutaneous Electric Nerve Stimulation therapy in type 2 diabetes mellitus patients with reduced salivary secretion To evaluate the effectiveness of Transcutaneous Electric Nerve Stimulation with and without ginger mouthwash usage on the salivary flow rate of type 2 diabetes mellitus patients with reduced salivary secretion OUTCOME/SCOPE The present study will find out whether the synergic effect of Transcutaneous Electric Nerve Stimulation and ginger mouthwash could be useful in improving the reduced salivary secretion
|