| CTRI Number |
CTRI/2025/08/093098 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of chewing gum and mouthwash in reducing dry mouth in people with high blood pressure and diabetes |
|
Scientific Title of Study
|
Xylitol Chewing-Gum Versus Moisturizing Mouthwash: A Comparative Study on Dry Mouth Relief for Hypertensive and Diabetic Patients |
| 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 Kukkala Ujwala |
| Designation |
Post graduate |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Sibar institute of dental sciences, Department of Public Health Dentistry, room no. 10,Takkellapadu, Guntur, Andhra Pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
7207813949 |
| Fax |
|
| Email |
16ujwala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devaki Talluri |
| Designation |
Professor |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Sibar institute of dental sciences, Department of Public Health Dentistry, room no. 10,Takkellapadu, Guntur, Andhra Pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9441306737 |
| Fax |
|
| Email |
devakitalluri@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srinivas Pachava |
| Designation |
HOD & Professor |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Sibar institute of dental sciences, Department of Public Health Dentistry, room no. 10,Takkellapadu, Guntur, Andhra Pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9849368466 |
| Fax |
|
| Email |
srinivaspachava@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar institute of dental sciences, Takkellapadu, Guntur, Andhra Pradesh Guntur ANDHRA PRADESH 522509 India |
|
|
Primary Sponsor
|
| Name |
Sibar institute of dental sciences |
| Address |
Sibar institute of dental sciences, Takkellapadu, Guntur, AndhraPradesh, India, 522509 |
| Type of Sponsor |
Other [Private dental college] |
|
|
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 Kukkala Ujwala |
Sibar institute of dental sciences |
Sibar institute of dental sciences, Department of Public Health Dentistry, room. no 10,Takkellapadu, Guntur, Andhra Pradesh
Guntur
ANDHRA PRADESH |
7207813949
16ujwala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sibar institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E085||Diabetes mellitus due to underlying condition with circulatory complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
moisturizing mouthwash |
Baseline dry mouth symptoms will be assessed in subjects who are included in the study and a mouthwash will be given and dry mouth symptoms will be assessed at immediately after the first use, after 7 days of continued use post intervention. mouthwash is advised to use 15 ml for 30 seconds for 2 times per day for 7 days |
| Intervention |
xylitol chewing gum
|
Baseline dry mouth symptoms will be assessed in subjects who are included in the study and chewing gum will be given and dry mouth symptoms will be assessed at immediately after the first use, after 7 days of continued use post intervention. chewing gums are advised to chew for 10 min for 2 times per day for 7 days
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals who have been diagnosed with hypertension, diabetes or both
Individuals who are under medication for hypertension and diabetes for at least 1 year and show symptoms of dry mouth according to Clinical Oral Dryness score (CODS)
Patients who provide consent.
|
|
| ExclusionCriteria |
| Details |
Newly diagnosed hypertensive and diabetic cases.
Individuals who are prone to allergy.
Individuals who smoke and consume alcohol.
Patients with systemic diseases and treatment other than hypertension and diabetes,
Patients who are un cooperative and not willing to participate.
Patients who are mentally unstable
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of xylitol-containing chewing gum and moisturizing mouthwash in reducing dry mouth symptoms among hypertensive and diabetic patients. |
at baseline, immediately after 1st use and after 7 days use |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of xylitol-containing chewing gum & moisturizing mouthwash in alleviating dry mouth symptoms among hypertensive & diabetic patients, & to assess patient-reported satisfaction with both. |
at baseline, immediately after 1st use & after 7 days use |
|
|
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)
|
30/08/2025 |
| 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="1"
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
|
40 Participants with hypertension and diabetes experiencing xerostomia will
be selected. Subjects will be explained the entire procedure and written
consent is obtained from each of them. The subjects will be selected based on
inclusion and exclusion criteria. A purposive sampling technique will be
employed in this study. Demographic characteristics of the study participants
will be obtained. Participants will be randomly allocated into two groups (n=20
each). Group-1 will receive xylitol-containing chewing gum, Group-2 will receive
moisturizing mouthwash. Dry mouth scores were recorded subjectively and
objectively at baseline, immediately after the first use, after 7 days of
continued use. Participant feedback was gathered using the Product Performance
and Attributes Questionnaire (PPAQ). |