| CTRI Number |
CTRI/2026/02/105074 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Person-Centered Oral Health Coaching on Preventing Tooth Decay in Young Children |
|
Scientific Title of Study
|
Effect of a Behavioural Change Communication Intervention on the Oral Health Status of Young Children – A Randomized Controlled 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 Arun Mamachan Xavier |
| Designation |
Professor |
| Affiliation |
Amrita School of Dentistry, Amrita Vishwa Vidyapeetham |
| Address |
Department of Pediatric & Preventive Dentistry
Amrita School of Dentistry
AIMS, Ponekkara P.O.,
Kochi, Kerala
Pin: 682041
Ernakulam
KERALA
682041
India |
| Phone |
09539084820 |
| Fax |
|
| Email |
arunmamachan@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekar Janakiram |
| Designation |
Professor and Head |
| Affiliation |
Amrita School of Dentistry, Amrita Vishwa Vidyapeetham |
| Address |
Department of Public Health Dentistry, Amrita School of Dentistry
AIMS, Ponekkara P.O
Kochi, Kerala
Pin: 682041
Ernakulam
KERALA
682041
India |
| Phone |
9481789572 |
| Fax |
|
| Email |
sekarcandra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandrashekar Janakiram |
| Designation |
Professor and Head |
| Affiliation |
Amrita School of Dentistry, Amrita Vishwa Vidyapeetham |
| Address |
Department of Public Health Dentistry, Amrita School of Dentistry
AIMS, Ponekkara P.O
Kochi, Kerala
Pin: 682041
Ernakulam
KERALA
682041
India |
| Phone |
9481789572 |
| Fax |
|
| Email |
sekarcandra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Amrita School of Dentistry |
| Address |
Aims , Ponekkara P.O, 682041,Kochi , Kerala |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Arun Mamachan Xavier |
Amrita School of Dentistry |
Room no: 5, 1st floor, Department of Paediatric and Preventive Dentistry, Amrita School of Dentistry, AIMS Ponekkara P.O. Kochi-41, Ernakulam, Kerala
Ernakulam
KERALA |
9539084820
arunmamachan@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Amrita School of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents, Caregiveres |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Children who receive the standard care |
Pertinent oral health information will be provided timely and oral health concerns will be addressed as per individual needs. |
| Intervention |
Person-Centered Oral Health Coaching |
This would involve behaviour change talk to parents and children through reflective listening, and reinforcement of commitments. It will also involve interviewing, oral health/knowledge assessment and self-motivation. Each session will last up to a maximum of 20-30 minutes. |
| Intervention |
Person-Centered Oral Health Coaching combined with Audio-visual media |
This would involve behaviour change talk to parents and children through reflective listening, and reinforcement of commitments with the aid of audio-visual media. Similar to group 1, it will also involve interviewing, oral health/knowledge assessment and self-motivation. Each session will last up to a maximum of 20-30 minutes. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
4.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between 2-4 years having no caries or not more than Type II ECC at the initiation of the study
2. Parents of children having a minimum education qualification up to graduation.
3. Parents willing to enroll their children for participation.
|
|
| ExclusionCriteria |
| Details |
1.Children having Type III ECC
2.Participants with known cognitive and psychological impairment.
3.Participants with any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of the participation in the trial, or may influence the result of the trial.
4.Participants who have participated in any similar research trial in the past 12 weeks. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dental caries Incidence, Oral hygeine status, and Gingival health of Children |
Baseline, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Parental oral health knowledge, behaviour and practices
2.Child oral health behaviour and practices
|
Baseline, 6 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="660"
Sample Size from India="660"
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)
|
05/10/2026 |
| 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="2"
Months="6"
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
|
A randomised controlled trial will be adopted to
assess the effect of Behaviour Change Communication Intervention on the oral
health the oral health status and practices of pre-school children over 2.6
years. The population will consist of 660 children aged 2-4 years who will be
consulting in the department of Paediatric and Preventive Dentistry of Amrita
School of Dentistry, Amrita Institute of Medical Sciences. The study sample
will be randomly allocated to any of the three trial groups including one
control group. The study groups receive person-centered oral heath coaching
with/without audio-visual media/standard care. Pertinent oral health
information will be provided to all groups including the control group. Inter-group
and intra-group statistical analysis will done appropriately using ANOVA,
repeated measures ANOVA, Chi-square test and Kruskal Wallis test. Missing
values will be handled using multiple imputation .Statistical significance will
be set at p < 0.05. |