| CTRI Number |
CTRI/2025/12/099962 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the Effect of Oral Melatonin Premedication on Sedation and Anxiety in Children of Different Age Groups Undergoing Pediatric Dental Procedures |
|
Scientific Title of Study
|
Efficacy of Oral Melatonin as Premedication in uncooperative patients: A Clinical Study |
| Trial Acronym |
MEL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Charu Aggarwal |
| Designation |
Postgraduate |
| Affiliation |
|
| Address |
K.D. Dental College and Hospital, Chattikara, NH-19, Mathura
Mathura
UTTAR PRADESH
281001
India |
| Phone |
09896220389 |
| Fax |
|
| Email |
charuaggarwal5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sonal Gupta |
| Designation |
Professor and Head |
| Affiliation |
|
| Address |
K.D. Dental College and Hospital, Chattikara, NH-19, Mathura
Mathura
UTTAR PRADESH
281001
India |
| Phone |
9690440001 |
| Fax |
|
| Email |
sonalpedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sonal Gupta |
| Designation |
Professor and Head |
| Affiliation |
|
| Address |
K.D. Dental College and Hospital, Chattikara, NH-19, Mathura
Mathura
UTTAR PRADESH
281001
India |
| Phone |
9690440001 |
| Fax |
|
| Email |
sonalpedo@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Charu Aggarwal |
| Address |
K.D. Dental College and Hospital, Chattikara, NH-19, Mathura |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sonal Gupta |
K.D. Dental College and Hospital, Chattikara, NH-19, Mathura |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Charu Aggarwal |
K.D. Dental College and Hospital |
K.D. Dental College and Hospital, Chattikara, NH-19, Mathura
Mathura
UTTAR PRADESH |
09896220389
charuaggarwal5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KDDC ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pediatric Dental Patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Melatonin |
Oral melatonin administered as a single premedication dose prior to pediatric dental treatment. The dosage will be calculated using Young’s formula, in the range of 0.25 to 0.5 mg/kg body weight. The medication will be given orally only once, immediately before the dental procedure. No repeat dosing will be performed. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children of age group between 3-12 years
ASA I (normal, healthy) and ASA II (mild systemic illness)
Frankel rating 2 and 3
|
|
| ExclusionCriteria |
| Details |
Children with a history of systemic disease
Frankel rating 1
Developmental delay
ASA III (a patient with a severe systemic disease) and ASA IV (a patient with a severe systemic ailment that continuously threatens life) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
SEATION EFFICACY
ANXIOLYSIS |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Behavioral cooperation
- Physiological parameters
- Recovery profile
- Postoperative effects
|
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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 4 |
|
Date of First Enrollment (India)
|
01/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study aims to evaluate the efficacy and safety of oral melatonin as a sedative agent in pediatric dental patients aged 3–12 years. The primary objective is to assess the sedation success rate and anxiety reduction during dental procedures, using standardized behavioral and sedation scales. Secondary objectives include evaluating child cooperation, physiological stability (heart rate, oxygen saturation, blood pressure), recovery profile, and adverse events. Children requiring dental treatment under sedation will be randomly allocated to receive oral melatonin prior to the procedure. Sedation depth, treatment completion, and recovery will be documented. The study seeks to determine whether melatonin can serve as a safe, effective, and well-tolerated alternative to conventional sedatives in pediatric dentistry. |