CTRI Number |
CTRI/2020/12/029470 [Registered on: 01/12/2020] Trial Registered Prospectively |
Last Modified On: |
27/10/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
EVALUATION OF PAIN AFTER SINGLE SITTING ROOT CANAL TREATMENT USING HAND AND ROTARY INSTRUMENTS |
Scientific Title of Study
|
COMPARATIVE EVALUATION OF POST-OPERATIVE PAIN AFTER SINGLE SITTING PULPECTOMY USING HAND AND ROTARY INSTRUMENTATION IN PRIMARY MOLARS OF CHILDREN – A RANDOMISED CONTROL STUDY |
Trial Acronym |
PAHRI |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Nivedita Saxena |
Designation |
Post graduate Student |
Affiliation |
KLE VK Institute of Dental Sciences. |
Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY KLE VK INSTITUTE OF DENTAL SCIENCES, KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH (KAHER), NEHRU NAGAR,BELAGAVI. KLE VK INSTITUTE OF DENTAL SCIENCES, KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH (KAHER), NEHRU NAGAR,BELAGAVI. Belgaum KARNATAKA 590010 India |
Phone |
6375297559 |
Fax |
|
Email |
niveditasaxena40@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shivayogi M Hugar |
Designation |
Professor and Head |
Affiliation |
KLE VK Institute of Dental Sciences. |
Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY KLE VK INSTITUTE OF DENTAL SCIENCES, KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH (KAHER), NEHRU NAGAR,BELAGAVI. KLE VK INSTITUTE OF DENTAL SCIENCES, KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH (KAHER), NEHRU NAGAR,BELAGAVI. Belgaum KARNATAKA 590010 India |
Phone |
9986436448 |
Fax |
|
Email |
dr.hugarsm@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Nivedita Saxena |
Designation |
Post graduate Student |
Affiliation |
KLE VK Institute of Dental Sciences. |
Address |
Department of Pediatric and Preventive Dentistry,
KLE V. K. Institute of Dental Sciences, KLE Academy of Higher Education And Research (KAHER),
Nehru Nagar,
Belagavi.
KLE V. K. Institute of Dental Sciences, KLE Academy of Higher Education And Research (KAHER),
Nehru Nagar,
Belagavi.
Belgaum KARNATAKA 590010 India |
Phone |
6375297559 |
Fax |
|
Email |
niveditasaxena40@gmail.com |
|
Source of Monetary or Material Support
|
KLE VK INSTITUTE OF DENTAL SCIENCES |
|
Primary Sponsor
|
Name |
Department of Pediatric and Preventive Dentistry |
Address |
Department of Pediatric and Preventive Dentistry, KLE VK Institute of Dental Sciences, Belagavi. |
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 |
Dr Nivedita Saxena |
Department of Pediatric and Preventive Dentistry |
KAHERs KLE VK Institute of Dental Sciences, Nehru Nagar, Belagavi Belgaum KARNATAKA |
6375297559
niveditasaxena40@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Research and Ethics committee KLE VK Institute of Dental Sciences |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Manual, K Files |
The operator (Principal Investigator) shall perform all the procedures under Standard Operating Protocols. Local anesthesia will be given and rubber dam will be applied. Access cavity preparation will be done using round diamond bur followed by chemo-mechanical instrumentation using K-files in Group A After that obturation will be done by Zinc Oxide Eugenol followed by filing with the suitable restorative material.Patient will be recalled after a week for the placement of Stainless Steel crown. |
Intervention |
Pediatric rotary files |
The operator (Principal Investigator) shall perform all the procedures under Standard Operating Protocols. Local anesthesia will be given and rubber dam will be applied. Access cavity preparation will be done using round diamond bur followed by chemo-mechanical instrumentation using Pediatric Rotary files in Group B. After that obturation will be done by Zinc Oxide Eugenol followed by filing with the suitable restorative material.
Patient will be recalled after a week for the placement of Stainless Steel crown.
|
|
Inclusion Criteria
|
Age From |
4.00 Year(s) |
Age To |
8.00 Year(s) |
Gender |
Both |
Details |
1. Children in the age group of 4-8 years.
2. Children with Frankl’s behaviour rating scale of positive (+) and definitely positive (++).
3. Tooth with the history of spontaneous pain.
4. Radiographic evaluation of the tooth showing irreversible pulpitis.
5. Primary molars with minimum two third of the root length.
6. Patients who are willing to undergo treatment
|
|
ExclusionCriteria |
Details |
1. Children with systemic diseases and special health care needs.
2. Non-vital teeth having signs of abscess, sinus and fistula.
3. Primary molars with pathologic mobility and evidence of root fracture, trauma.
4. Primary molars having furcation radiolucency.
5. Primary molars with calcified root canals.
6. Primary molars with more than two third root resorption, internal resorption and developmental anomalies.
7. Patients who are not willing to undergo treatment.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Post operative pain |
24 hours
48 hours
72 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
Reduction in pain, swelling and increasing the quality of life |
After 24hours, 48 hours, 72hours |
|
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
|
N/A |
Date of First Enrollment (India)
|
01/01/2021 |
Date of Study Completion (India) |
27/08/2021 |
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
|
None |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Primary teeth act as a natural space maintainer and guide the
eruption of permanent teeth to their optimal position in the dental arch. The
retention and preservation of the primary tooth in the dental arch in its
normal function and free of pathology is of utmost importance. Therefore, it is
of prime importance as a Pediatric Dentist to maintain the integrity of tooth in
the dental arch till natural exfoliation takes place.1Paediatric
dentistry is changing from surgical treatment planning to conserving primary
teeth till their natural exfoliation occurs for proper occlusal guidance and
also aid in mastication. Restoration is carried out in carious teeth involving
enamel and dentine and pulp therapy in those which are showing pulpal and
peri-radicular involvement.2
Pulpectomy
procedure consists of various steps out of which absolute chemo-mechanical
preparation of the root canal system is a requisite for a successful endodontic
treatment. Studies have shown higher
frequency of post-endodontic pain following multiple visits as compared to
single-visit endodontic treatments.3
Conventionally,
manual K-files have proven to be a gold standard providing excellent tactile control and sharp,
long-lasting cutting surfaces. Despite the widespread use of manual
instrumentation for pulpectomy in primary teeth, there is incidence of
post-operative pain due to linear filing motion.2The post-endodontic pain may be caused due to ongoing inflammatory
processes or changes in the periapical tissue pressure post instrumentation.4
Although, K-files
have aided in the pediatric endodontic treatment since ages and proved
successful yet there is a need felt to introduce a newer filing system to
reduce the incidence of post endodontic pain.5Rotary instruments
were introduced to Paediatric dentistry by Barr et al in 2000.With the
development of nickel–titanium (NiTi) rotary shaping systems in the recent
past, a reduction in the timing and increased clinical efficacy has been seen.5
The NiTi alloy
proves more effective for cleaning the tortuous and irregular canal walls of
the primary teeth due to, Greater
elasticity, Central canal preparation, Less apical
transportation, Use of lesser number of files. Hence it marks a far better
choice for Paediatric endodontic procedures in the upcoming era. 6
When
literature search was carried out in last three months, there were no studies
conducted in Indian scenario and worldwide regarding post- operative pain using
Hand Files and Rotary Files after Single Sitting Pulpectomy. So, an attempt is
made to carry out this research to evaluate and compare the post-operative pain using Hand Files and
Rotary Files After Single Sitting Pulpectomy. |