| CTRI Number |
CTRI/2025/06/089570 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating the efficacy of dissolving xylitol chewable tablets versus xylitol chewing gum on bacterial count, plaque accumulation and gingival inflammation in senior citizens. |
|
Scientific Title of Study
|
A randomized double-blind, parallel, clinical trial evaluating the efficacy of dissolving xylitol chewable tablets versus xylitol chewing gum on bacterial count, plaque accumulation and gingival inflammation in senior citizens. |
| 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 Tannu Kumari |
| Designation |
Postgraduate student |
| Affiliation |
Teerthanker mahaveer dental college and research centre |
| Address |
Teerthanker mahaveer dental college and research centre, moradabad, uttar paradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8126783502 |
| Fax |
|
| Email |
tankashra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pradeep Tangade |
| Designation |
Principal and Head of Department |
| Affiliation |
Teerthanker mahaveer dental college and research centre |
| Address |
Teerthanker mahaveer dental college and research centre, moradabad, uttar paradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9997466339 |
| Fax |
|
| Email |
drpradeeptangade.dental@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tannu Kumari |
| Designation |
Postgraduate student |
| Affiliation |
Teerthanker mahaveer dental college and research centre |
| Address |
Teerthanker mahaveer dental college and research centre, moradabad, uttar paradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8126783502 |
| Fax |
|
| Email |
tankashra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Dental college and reasearch centre,moradabad |
|
|
Primary Sponsor
|
| Name |
Dr Tannu Kumari |
| Address |
Teerthanker Mahaveer Dental college and reasearch centre,moradabad, uttar pradesh |
| 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 |
| TANNU KUMARI |
Vedic Vanaprastha Ashram |
Vedic Vanaprastha Ashram, Moradabad, Uttar Pradesh, India
Moradabad
UTTAR PRADESH |
8126783502
tankashra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Teerthanker mahaveer dental college and research centre |
Approved |
| Vedic Vanaprastha Ashram |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
xylitol chewing gum |
Trident Original gum
Comparator Group: Xylitol Chewing Gum
Frequency: 1 chewing gums, 3 times daily (morning, afternoon, evening)
Total Duration: 30 days |
| Intervention |
xylitol-dissolving chewable tablets |
Listerine Ready Tabs Intervention Group: Xylitol Dissolving Tablets
Frequency: 1 tablet, 3 times daily (morning, afternoon, evening)
Total Duration: 30 days
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
74.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria involved at least 20 natural teeth and mild to moderate gingival inflammation. |
|
| ExclusionCriteria |
| Details |
Subjects with systemic illness impacting oral health, history of known allergy to xylitol, or intake of antibiotics or antimicrobial mouthwashes over the last three months were excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bacterial count,Plaque accumulation, Gingival inflammation |
0-30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| salivary pH or flow rate |
0-30 days |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/07/2025 |
| Date of Study Completion (India) |
07/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This randomized, double-blind, parallel-group clinical trial aims to evaluate and compare the efficacy of dissolving xylitol chewable tablets and chewing gum on salivary bacterial count, plaque accumulation, and gingival inflammation in senior citizens. 96 participants aged 60 years and above will be enrolled and randomly assigned to one of two intervention groups. Clinical parameters will be recorded at baseline and after 30 days of intervention.
This study aims to evaluate the efficacy of dissolving xylitol chewable tablets compared to xylitol chewing gum as a substitute for toothbrushing and mouth rinsing in countering bacterial levels, plaque formation, and gingival inflammation in elderly people.
The null hypothesis is that the xylitol-dissolving chewable tablets and xylitol chewing gum are equally effective on salivary Streptococcus mutans bacterial count, plaque formation, and gingival inflammation among senior citizens.
|