| CTRI Number |
CTRI/2025/09/094470 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Oral Melatonin and Triclofos as Premedication |
|
Scientific Title of Study
|
EFFICACY OF ORAL MELATONIN AND ORAL TRICLOFOS AS SEDATIVE FOR CHILDREN UNDERGOING DENTAL TREATMENT: A CLINICAL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohan Shrivastava |
| Designation |
Post Graduate Student |
| Affiliation |
K.D. Dental College and Hospital |
| Address |
Room Number:3, Department of Pediatric and Preventive Dentistry, K.D. Dental College and Hospital, NH-19, Agra-Delhi national highway
Mathura
UTTAR PRADESH
281006
India |
| Phone |
6377547484 |
| Fax |
|
| Email |
rohanshrivastava5555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sonal Gupta |
| Designation |
Head of Department, Department of Pediatric and Preventive Dentistry |
| Affiliation |
K.D. Dental College and Hospital |
| Address |
Room Number:3, Department of Pediatric and Preventive Dentistry, K.D. Dental College and Hospital, NH-19, Agra-Delhi national highway
Mathura
UTTAR PRADESH
281006
India |
| Phone |
6377547484 |
| Fax |
|
| Email |
sonalpedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohan Shrivastava |
| Designation |
Post Graduate Student |
| Affiliation |
K.D. Dental College and Hospital |
| Address |
Room Number:3, Department of Pediatric and Preventive Dentistry, K.D. Dental College and Hospital, NH-19, Agra-Delhi national highway
Mathura
UTTAR PRADESH
281006
India |
| Phone |
6377547484 |
| Fax |
|
| Email |
rohanshrivastava5555@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rohan Shrivastava |
| Address |
Room no. 3, Department of Pediatric and Preventive Dentistry, K.D. Dental College and Hospital, NH-19, Agra-Delhi national highway |
| 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 |
| Dr Rohan Shrivastava |
K. D. Dental College and Hospital |
Room Number:3, Department of Pediatric and Preventive Dentistry, K.D. Dental College and Hospital, NH-19, Agra-Delhi national highway
Mathura
UTTAR PRADESH |
6377547484
rohanshrivastava5555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K. D. Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal with no systemic diseases. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Melatonin |
Melatonin (Brand name- Altonil)
Dose- Patient specific based on body weight.
Duration of administration- 60 minutes before dental treatment
Rout of administration- Orally |
| Comparator Agent |
Triclofos Sodium |
Triclofos Sodium (brand name- slep drops)
Dose- Patient specific based on body weight.
Duration- 45 minutes before the dental treatment.
Rout of administration- Orall |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
children of age group 4-9 years with Frankl’s behavior rating scale 2, 3 and the American Society of Anaesthesiologists (ASA) I and II physical status. |
|
| ExclusionCriteria |
| Details |
Frankel behavior rating scale 1, 4, patients with developmental delays, preterm, and a history of chronic disease. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Melatonin was better than Triclofos Sodium, but both can be used as premedication drugs. |
Immediately after 60 minutes of administration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Melatonin causes more sedation than Triclofos Sodium. |
after 2 hours of administration no side effects were seen in Melatonin group but some side effects were seen in triclofos group |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
19/09/2025 |
| 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
|
Aim: To compare the pre and post use of oral Melatonin and oral Triclofos as oral sedative drug on anxiety, sedation, cognitive and psychomotor function to perform satisfactory dental treatment on uncooperative children. Materials and Methodology: A total number of 100 patients age range between 4 to 9 years were scheduled for dental treatment were randomly divided into two groups as Group I and II and administered with Melatonin and Triclofos Sodium respectively to determine changes in anxiety, cognitive, psychomotor and sedation score pre and post treatment. Data were analysed using an unpaired/paired t-test and P < 0.05 was contemplate statistically significant. Result: In pre and post treatment results, there were decreased in cognitive scores and anxiety scores significantly, and sedation scores were increased after 60 mins of Melatonin and Triclofos medication. When both medicines compared, Melatonin showed better sedative effect and more reduction in anxiety score than Triclofos Sodium with insignificant differences. Conclusion: Both melatonin and triclofos sodium are effective drugs that can be used as potent premedication to reduce anxiety associated with dental procedures. |