| CTRI Number |
CTRI/2024/04/065408 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
07/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the effectiveness of electric stimulation therapy and pilocarpine mouthwash on salivary flow in patients with dry mouth: clinical trial |
|
Scientific Title of Study
|
Comparing the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) and Pilocarpine mouthwash with standard care on salivary flow in patients with radiation-induced xerostomia: a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Arpit Gupta |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Room no.107, Preventive Clinic Ground Floor, Oral Health Sciences Centre PGIMER Sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8826674284 |
| Fax |
|
| Email |
arpitg.in@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Arpit Gupta |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Room no.107, Preventive Clinic Ground Floor, Oral Health Sciences Centre PGIMER Sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8826674284 |
| Fax |
|
| Email |
arpitg.in@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Arpit Gupta |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Room no.107, Preventive Clinic Ground Floor, Oral Health Sciences Centre PGIMER Sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8826674284 |
| Fax |
|
| Email |
arpitg.in@gmail.com |
|
|
Source of Monetary or Material Support
|
| Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Arpit Gupta |
Postgraduate Institute of Medical Education and Research |
Room no.107, Preventive Clinic Ground Floor, Oral Health Sciences Centre PGIMER Sector 12 Chandigarh
Chandigarh
CHANDIGARH |
8826674284
arpitg.in@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural), PGIMER, Chandigarh |
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 |
| Intervention |
2% Pilocarpine mouthwash (3 times a day for a period of 1 month)
|
About 2% v/v solution will be prepared in Department of Pharmacology, PGIMER, Chandigarh. Patients will be provided with labeled containers alongside proper instructions, not to ingest the solution while rinsing. The patient will be instructed to use 15 mL solution not more than three times a day and not for more than 2 minutes. Total Duration: 1 month.
|
| Comparator Agent |
Standard care (for a period of 3 months)
|
The participants will receive comprehensive instructions inclusive of maintenance of proper hydration levels by drinking water frequently throughout the day, instructions for oral hygiene maintenance, emphasis on the value of using fluoride toothpaste and flossing on a regular basis. They will also be encouraged to visit for routine dental check-ups. Total Duration: 3 months. |
| Intervention |
TENS therapy (2 session per week and 20 minutes per session for a period of 3 months) |
A device called transcutaneous electrical nerve stimulation (TENS) uses electric current that is modified for pulse, frequency, and intensity for therapeutic purposes. TENS machine will be activated, the pulse rate will be fixed at 50 Hz, and the intensity will be gradually increased to a maximum tolerable level for each patient. At optimal intensity the maximum intensity that the participant still perceived to be comfortable for 2 session per week and 20 minutes per session for a period of 3 months. In order to administer this therapy, surface electrode pads will be applied externally to the skin that covers the parotid and submandibular glands (superinferiorly between the area of the mandibles head and above its lower border, and anteriorly between the tragus of the ear and the mid-masseter region). Total Duration: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Participants who meet the eligibility requirements for the study are those who have completed radiation therapy with or without chemotherapy or surgery between three months and two years prior to study entry, and who report symptoms of oral dryness and decreased salivary flow (≤ 0.2 mL/min).
All participants who are willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
Participants with a history of known salivary gland pathologies, such as rheumatoid arthritis and Sjogrens syndrome.
Those who are taking drugs like pilocarpine, cevimeline, inhalatory glucocorticoids, opioids, benzodiazepines, diuretics, or who have undergone surgery involving the salivary glands.
Participants with hearing aids, cochlear implants, pacemakers or defibrillators will be excluded from the study.
Participants who have peptic ulcers or uncontrolled asthma will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the salivary flow |
Baseline, 1month, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life. |
Baseline, 1 month, 3 months and 6 months |
| Oral dryness. |
Baseline, 1 month, 3 months and 6 months |
| OHI-S scores. |
Baseline, 1 month, 3 months and 6 months |
| pH and viscosity of saliva. |
Baseline, 1 month, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 3 |
|
Date of First Enrollment (India)
|
18/04/2024 |
| 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 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
|
Background: Patient with radiation-induced xerostomia is a well-recognized consequence of radiation therapy, particularly in cases involving head and neck malignancies. This condition, characterized by a persistent and often severe dryness of the mouth, arises due to the detrimental effects of radiation on the salivary ductal system. While ageing is associated with a natural decline in salivary function, radiation-induced xerostomia exacerbates this physiological change, resulting in a substantial reduction in salivary production. Methods: A randomized controlled trial involving 75 patients will be randomly allocated to Group A: TENS therapy, Group B: 2% Pilocarpine mouthwash and Group C: Standard care with 25 in each group. Pre- and post-intervention unstimulated saliva will be collected. Participants’ salivary flow, xerostomia-related quality of life, oral dryness, oral hygiene index-simplified (OHI-S) score, salivary pH and viscosity will be recorded at baseline and 1st, 3rdand 6th-month post-intervention. The Challacombe scale of clinical oral dryness and the Xerostomia-Related Quality of Life Scale (XeQoLS), respectively, will be used to measure the degree of xerostomia and oral health-related quality of life. Appropriate descriptive and inferential statistics will be applied. Statistical significance is set at p≤0.05. Expected outcome: This trial will help determine whether TENS therapy and 2% pilocarpine mouthwash are equally effective at increasing salivary flow and improving the quality of secreted saliva among patients with oral dryness when compared with the use of standard care. |