| CTRI Number |
CTRI/2023/02/049529 [Registered on: 07/02/2023] Trial Registered Prospectively |
| Last Modified On: |
05/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF SALIVARY PH, FLOWRATE , BUFFERING CAPACITY AND ENZYME LEVEL IN CHILDREN WITH AND WITHOUT CARIES
|
|
Scientific Title of Study
|
ASSESSMENT OF SALIVARY PH, FLOW RATE, BUFFERING CAPACITY AND ALPHA AMYLASE ENZYME ACTIVITY IN CARIES FREE AND CARIES ACTIVE CHILDREN IN EARLY CHILDHOOD CARIES – A RANDOMIZED CLINICAL TRIAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pallavi |
| Designation |
Post Graduate Student |
| Affiliation |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
| Address |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL RAMOHALLI CROSS, MYSORE ROAD, BANGALORE.
Bangalore
KARNATAKA
560074
India |
| Phone |
7022231534 |
| Fax |
|
| Email |
pallavinkuri1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umpathy T |
| Designation |
Professor |
| Affiliation |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
| Address |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL RAMOHALLI CROSS, MYSORE ROAD, BANGALORE.
Bangalore
KARNATAKA
560074
India |
| Phone |
9986478744 |
| Fax |
|
| Email |
umapathygowda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi |
| Designation |
Post Graduate Student |
| Affiliation |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
| Address |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL RAMOHALLI CROSS, MYSORE ROAD, BANGALORE.
Bangalore
KARNATAKA
560074
India |
| Phone |
7022231534 |
| Fax |
|
| Email |
pallavinkuri1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari medical college and hospital bangalore
|
|
|
Primary Sponsor
|
| Name |
Dr Pallavi |
| Address |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL. DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY 14 CROSS RAMOHALLI CROSS, MYSORE ROAD, BANGALORE. |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 Pallavi |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY 14 CROSS RAMOHALLI CROSS, MYSORE ROAD, BANGALORE.
Bangalore
KARNATAKA |
7022231534
pallavinkuri1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
EARLY CHILDHOOD CARIES |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1 Children of 3-6 years of age.
2 Children with 4 and more than 4 active
carious lesions.
3 Children with no caries.
4 Parents giving consent for the study.
|
|
| ExclusionCriteria |
| Details |
1 Children who received fluoride topical
application during the last 1 month
2 Children requiring special health care
needs.
3 Pulpally involved teeth.
4 Children who were on antibiotic therapy
within the past 3 months.
5 Children with genetic diseases or
syndromes.
6 Children on any medications.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the pH, Flowrate, Buffering capacity in the saliva of children with and without caries using pH meter. To estimate the salivary alpha amylase enzyme activity in the saliva of children with and without caries using DNS Reagent and UV spectrophotometer. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/02/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study will be done on 50 subjects to assess salivary pH, flow rate, buffering capacity and alpha amylase in children with caries and without caries aged 3-6 years. 25 subjects in each group, A thorough clinical examination will be done for active carious lesions using dmfs indices(>=4active caries). An unstimulated saliva sample is collected. The subjects will be asked to seat comfortably with eyes open, head tilted slightly forward with restricted orofacial movements, and will be instructed to rest for 5 min. Saliva will be allowed to accumulate in the floor of the mouth, and the subjects will be asked to spit into a sterile saliva collecting vial. All the samples will be transferred aseptically and sent for analysis to assess salivary pH, flowrate, buffering capacity and alpha amylase enzyme activity. |