| CTRI Number |
CTRI/2023/06/053728 [Registered on: 09/06/2023] Trial Registered Prospectively |
| Last Modified On: |
09/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
To check whether Analgesics are required every time following extraction of primary teeth |
|
Scientific Title of Study
|
Analgesics usage following Extraction of Primary teeth - A Multi-center Cross-sectional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K VIVEK |
| Designation |
Reader |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pediatric and Preventive Dentistry,
Sri Ramachandra Dental college and Hospital,
SRIHER,
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9442389569 |
| Fax |
|
| Email |
vickykrish88@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K VIVEK |
| Designation |
Reader |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pediatric and Preventive Dentistry,
Sri Ramachandra Dental college and Hospital,
SRIHER,
Porur, Chennai
TAMIL NADU
600116
India |
| Phone |
9442389569 |
| Fax |
|
| Email |
vickykrish88@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr K VIVEK |
| Designation |
Reader |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pediatric and Preventive Dentistry,
Sri Ramachandra Dental college and Hospital,
SRIHER,
Porur, Chennai
TAMIL NADU
600116
India |
| Phone |
9442389569 |
| Fax |
|
| Email |
vickykrish88@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and PReventive dentistry, Sri Ramachandra Dental college and Hospital, Porur, CHennai |
|
|
Primary Sponsor
|
| Name |
Self DrK Vivek |
| Address |
Department of Pediatric and Preventive, Sri Ramachandra Dental College and Hospital, Porur, Chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Preeti kalia |
Dentamedics Dental and Medical Centre |
286, Raja Ram Mohan Roy Road
Kolkata,
West Bengal
Kolkata
WEST BENGAL |
7421259632
Kaliapreeti27@gmail.com |
| DrMSMuthu |
Pedo Planet Children Dental Centre |
Porur Branch
161/63A, Mount Poonamallee High Road,
Porur,
Chennai
Chennai
TAMIL NADU |
9444045094
muthumurugan@gmail.com |
| Dr K Vivek |
Sri Ramachandra Faculty of Dental Sciences, SRIHER, |
Room no - 4, Department of Pediatric and Preventive Dentistry
Chennai
TAMIL NADU |
9442389569
vickykrish88@sriramachandra.edu.in |
| Dr Sanchit paul |
Tooth Tales |
Greater Noida,
Block D, Phi III
Uttar Pradesh- 201308
Ghazipur
UTTAR PRADESH |
9773857726
dr.sanchit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SRU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Convenience method of sampling |
he study sample will include children aged 4-
11 years who report to the participating institutions and dental hospitals |
| Comparator Agent |
Paracetamol and Ibuprofen (syrup and tablet) |
125mg and 250 mg - syrup and tablet |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
The Inclusion Criteria for the study will be primary teeth indicated for extraction for reasons
such as grossly decayed, primary teeth with pre- shedding mobility, over-retained deciduous
teeth, root stumps of primary teeth, orthodontic treatment, trauma, and whose parents will
provide consent. |
|
| ExclusionCriteria |
| Details |
The Exclusion Criteria for the study will be Children with special needs, history of wheezing, prolonged bleeding,
hypersensitivity, or allergic reactions to the analgesic being tested, those with extra-oral
swelling, history of previous analgesic intake 5 hours prior to tooth extraction will be excluded
from the study. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mandatory usage of analgesics for normal extraction of tooth can be avoided |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post extraction complications are very minimal in Intra-alveolar extractions |
6 months |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
17/06/2023 |
| 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="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pain management has been an integral part of dentistry, and pediatric dentistry in peculiar (Gazal
2007 ref 1) Pain endured after tooth extraction in children may cause anguish for both the child and
their parents (Baygin 2011 ref 1). This can lead to increased fear, avoidance of future dental
treatments, and other associated problems (Asley 2016 ref Carr 1999). Various techniques have been
tried to lessen the pain following dental extraction in children, but none have been very efficacious
(Gazal 2007 ref).
In previous studies, analgesic use in children following extraction of their teeth was reported to be
beneficial (Begin 2011 ref 3). Gazal G showed that the preoperative oral usage of analgesics had
favorable post-extraction pain relief properties over a placebo (Gazal G 2007 ref). Howbeit,
contentious reports have been found in the literature about the effectiveness of preoperative induced
analgesics on allaying post-extraction pain in pediatric populations. Nevertheless, studies on the use
of preoperative analgesics on alleviation of post-extraction pain in children are scarce. McGaw et al.
demonstrated ibuprofen to be more effectual than paracetamol or placebo for postoperative pain in
children undergoing permanent tooth extraction (McGaw et al.1987). Primosch et al. reported no
significant decrease in post-extraction pain between children in placebo and paracetamol groups
(Primosch et al. 1993). Primosch et al. also conducted a study of 60 children to evaluate the efficacy
of the pre-operative administration of ibuprofen and paracetamol compared with placebo for pain
relief after teeth extractions. They concluded that the pre-operative administration of neither
analgesic is superior to placebo administration (Primosch et al. 1995).
The management of pain is of particular importance in pediatric dentistry where patient perceptions
of dental treatment are being established. However, to date, there is no evidence stating the need to
prescribe analgesics for postoperative pain relief in children undergoing intra-alveolar extraction. The Aim of our study is to evaluate the usage of analgesic in children following primary tooth
extraction. |