| CTRI Number |
CTRI/2020/05/025447 [Registered on: 29/05/2020] Trial Registered Prospectively |
| Last Modified On: |
01/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
TO CHECK FOR CHANGE IN SALIVARY FLOW AFTER ORAL ATROPINE DROPS IN CHILDREN |
|
Scientific Title of Study
|
EVALUATION OF ALTERATION IN SALIVARY FLOW FOLLOWING ADMINISTRATION OF ATROPINE DROPS SUBLINGUALLY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1243-7580 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHANNON SAMUEL |
| Designation |
MDS RESIDENT |
| Affiliation |
CHRISTIAN DENTAL COLLEGE, Ludhiana |
| Address |
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY, CHRISTIAN DENTAL COLLEGE, LUDHIANA
Ludhiana
PUNJAB
141008
India |
| Phone |
07224917778 |
| Fax |
|
| Email |
drshannon90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHAILA |
| Designation |
PROFESSOR |
| Affiliation |
CHRISTIAN DENTAL COLLEGE, Ludhiana |
| Address |
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY, CHRISTIAN DENTAL COLLEGE, LUDHIANA
Ludhiana
PUNJAB
141008
India |
| Phone |
9872629087 |
| Fax |
|
| Email |
shaila224@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHANNON SAMUEL |
| Designation |
MDS RESIDENT |
| Affiliation |
CHRISTIAN DENTAL COLLEGE, Ludhiana |
| Address |
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY, CHRISTIAN DENTAL COLLEGE, LUDHIANA
PUNJAB
141008
India |
| Phone |
07224917778 |
| Fax |
|
| Email |
drshannon90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pedodontics and Preventive Dentistry, Christian Dental College and Hospital, Ludhiana, Punjab |
|
|
Primary Sponsor
|
| Name |
Department of Pedodontics and Preventive Dentistry |
| Address |
Christian Dental College and Hospital, Ludhiana, Punjab |
| Type of Sponsor |
Private medical college |
|
|
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 |
| SHANNON SAMUEL |
CHRISTIAN MEDICAL COLLEGE AND HOSPITAL |
ROOM NUMBER 08, DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY, CHRISTIAN DENTAL COLLEGE
Ludhiana
PUNJAB |
07224917778
drshannon90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
CHILDREN WITH NORMAL SALIVARY FLOW ABOVE BASELINE |
| Patients |
(1) ICD-10 Condition: K117||Disturbances of salivary secretion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Atropine Sulphate drops (1% w/v) |
atropine sulphate drops administered orally as per dosage guidelines 0.01-0.02 mg/kg of body weight |
| Comparator Agent |
Placebo |
Distilled water drops administered orally to control group. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children reporting to OPD for elective dental procedures.
Children belonging to group 1–2 (healthy or minor disease) according to the ASA (American Society of Anesthesiologists) Physical Status Classification System.
Children with salivary flow above baseline. |
|
| ExclusionCriteria |
| Details |
1. Children with oral mucosal lesions.
2. Children undergoing radiotherapy or chemotherapy.
3. Children on medications for underlying systemic conditions.
4. Known cases of cardiac conditions
5. Children with known allergy to atropine. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To quantitatively assess decrease in salivary secretion post administration of atropine sulphate drops during routine dental procedures. |
the salivary flow (stimulated and unstimulated) assessed over 3 time intervals 0 mins, 60 mins and 90 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the duration of regression to baseline salivary index post administration of drops. |
the decrease in baseline salivary index compared from 0 min, 60 mins and 90 mins. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/05/2020 |
| Date of Study Completion (India) |
11/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Salivation is a double-edged sword in dental practice. It is desired for its protective and healing nature to the oral structures but undesirable due to the need for isolation during most dental procedures. A clean and dry field of operation is a requisite in most of the dental procedures and becomes the parameter deciding the success of majority of treatment modalities. In Pedodontics it becomes essential for painless and quick measures to achieve this isolation so as to initiate maximum co-operation from the child. Atropine sulphate drops have been widely used intra-orally as they are known to decrease salivary secretion due to their muscarinic antagonistic activity. This study aims to evaluate the effect of atropine sulphate drops sublingually in decreasing the salivary flow during the span of a dental procedure. A dose-monitored locally administered drops propose to decrease the salivary secretion in this study and make isolation easier and effortless. They are short-acting with a reversible action so as to provide the patient and operator a safe working window. |