| CTRI Number |
CTRI/2024/11/077079 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing efficacy of pediatric hand protaper and rotary file. |
|
Scientific Title of Study
|
Comparative assessment of quality of obturation and instrumentation time using pediatric hand protaper and pediatric rotary file in primary mandibular molars: an in vivo 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 |
Dr Sachin Parmar |
| Designation |
PG STUDENT |
| Affiliation |
Government College of Dentistry, Indore |
| Address |
Room no. 18, Dept of Pediatric and Preventive Dentistry, Govt College of Dentistry, Sardar Patel Marg, opposite MY hospital, Indore, MADHYA PRADESH, 452001, India
Indore MADHYA PRADESH 452001 India |
| Phone |
7415606931 |
| Fax |
|
| Email |
drsachinparmar96@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anuradha Agrawal |
| Designation |
Associate Professor |
| Affiliation |
Government College of Dentistry, Indore |
| Address |
Room no. 18, Dept of Pediatric and Preventive Dentistry, Govt College of Dentistry, Sardar Patel Marg, opposite MY hospital, Indore, MADHYA PRADESH, 452001, India
Indore MADHYA PRADESH 452001 India |
| Phone |
9826436460 |
| Fax |
|
| Email |
anupiyush1@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sachin Parmar |
| Designation |
PG STUDENT |
| Affiliation |
Government College of Dentistry, Indore |
| Address |
Room no. 18, Dept of Pediatric and Preventive Dentistry, Govt College of Dentistry, Sardar Patel Marg, opposite MY hospital, Indore, MADHYA PRADESH, 452001, India
Indore MADHYA PRADESH 452001 India |
| Phone |
7415606931 |
| Fax |
|
| Email |
drsachinparmar96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government college of dentistry, indore |
|
|
Primary Sponsor
|
| Name |
Dr Sachin Parmar |
| Address |
Room no. 18, Dept of Pediatric and Preventive Dentistry, Govt. College of Dentistry, Sardar Patel Marg, opposite MY hospital MADHYA PRADESH, 452001, India |
| 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 Sachin Parmar |
Govt College of Dentistry |
Room no 18, Dept of pediatric and preventive dentistry, Opp M Y hospital, sardar patel marg, indore, 452001 Indore MADHYA PRADESH |
07415606931
drsachinparmar96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government College of Dentistry, Indore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No systemic condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kedo-S Square rotary file |
Group 2-
Twenty teeth underwent instrumentation with the Kedo-S Square rotary file system. Initially, canal preparation involved a size 20 K file, followed by the use of Kedo-S ‘Square’ rotary files (P1) connected to an Endodontic motor (WOODPECKER®, ENDO RADAR) operating at 300 rpm and 2.2 N/cm torque. |
| Intervention |
Kedo-SH hand protaper |
After thorough clinical examination, a standardized periapical radiograph (RVG) was obtained using paralleling angle technique for mandibular primary molar tooth undergoing single visit pulpectomy. To ensure precise radiographs, the Rinn XCP instrument (Dentsply Rinn, Elgin) was utilized in conjunction with radiographic parallelism and a standardized exposure technique, facilitating optimal visualization of the tooth structure and consistent reproducibility. Single visit pulpectomy was performed after randomly allocation of study group. Topical anesthesia was meticulously administered to each selected tooth with Benzocaine 20% gel (Lidayn, ORASPOT; Global Dent Aids Pvt. Ltd.). Subsequent anesthesia for inferior alveolar nerve block (IANB) was achieved by 2% lignocaine with 1:80,000 adrenaline local anesthetic solution (LIGNOX® 2% A, INDOCO REMEDIES Ltd.), Subjective and objective signs of successful anesthesia were evaluated. (Figures 5a and 5b) Subseq4uently, isolation was achieved with a rubber dam (Zodenta, German Stainless CE Rubber Dam Kit). Caries excavation was done using spoon excavator (API®#2980) and the access cavity was prepared using a round bur (BR 41, MANI) in a high-speed handpiece (NSK, PanaAir FX). Subsequently, the pulp chamber was uncovered using a sterile Pear-shaped bur (No. 330, Mani) and irrigated with Normal Saline (Bios, Biosynergy Lifecare Pvt Ltd. India) to eliminate dentinal debris. Coronal pulp amputation was performed with a round bur (BR 41, MANI), and any residual pulp tissue was excavated using a sterile spoon excavator (API® #2980). DG 16 explorer (API®) was used to locate the root canal orifice followed by finishing the access cavity
Canal patency was checked radiographically by inserting precurved No.10 K file (18mm, Mani). A diagnostic radiograph was taken with an endodontic file (K file, no.10, 18mm, Mani) placed in each canal to determine the root canal length, with the working length maintained 1 mm shy of the radiographic apex following Ingles method.
For biomechanical preparation of root canal, different file systems were used as per the selected study group-
GROUP 1:
Twenty teeth were prepared using Kedo SH pediatric hand files (Reeganz Dental Care Pvt. Ltd. India) following the manufacturer’s guidelines. The P1 file was employed initially for establishing patency in the molar canals, P2 was used for pulp extirpation, D1 for shaping narrower canals, and E1 for shaping wider canals. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.Children with the age of 4-8 years old in good general health.
2.Child able to cooperate.
3.Parent/caregiver for the child have consented.
4.Primary mandibular molars indicated for pulpectomy.
5.At least two-thirds of the residual root length and enough coronal tooth structure preserved.
|
|
| ExclusionCriteria |
| Details |
1.Children with systemic disease.
2.Teeth exhibiting sinus tract formation and pathological root resorption. Insufficient coronal tooth structure.
3.Tooth with physiological mobility.
4.Tooth with dental anomalies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Instrumentation Time and Quality of Obturation |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Obturation |
at baseline
and after 1 week followup |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
05/12/2024 |
| 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="0" Days="20" |
|
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
|
The primary aim of Pediatric
Dentistry is to preserve both primary and permanent teeth in a functional state
to support the development of the stomatognathic system. Primary teeth are
precious as they help in maintaining the arch integrity, nutrition, phonation,
aesthetic appearance and guide the permanent teeth in eruption. Dental
caries is most common childhood disease occur due to improper oral hygiene
practice, increase in carbohydrate intake and other deleterious oral habits.
Dental caries can progress to involve the pulp. Early involvement of pulp can
lead to pulpal and periapical diseases. The primary cause typically stems from
microorganisms residing within the affected tooth. Nonetheless, numerous other
influences, including bacterial, mechanical, thermal, electrical, and chemical
factors, can also impact pulp health. The dental pulp is composed of a loose
network of connective tissue containing small blood vessels, nerves, and
lymphatic vessels. Cellular elements within the pulp include odontoblasts,
fibroblasts, undifferentiated cells, and immune system cells. Like other loose
connective tissues, the pulp reacts to environmental changes. However, its
distinct features such as the absence of collateral circulation, the presence
of dentin-forming odontoblasts, and its encasement in rigid dentin make its inflammatory
reaction unlike that of any other organ in the human body. Adequate
treatment of pulp involved deciduous teeth is the prime service a pediatric
dentist can avail for the child patient. Pulp therapy for primary teeth, based
on diagnosis can be vital pulp therapies which includes use of protective
liners, indirect pulp treatment, direct pulp treatment, pulpotomy and non-vital
pulp therapy i.e. pulpectomy. Success of pulpectomy depends upon
several factors such as biomechanical preparation, irrigation, disinfection,
and obturation. Root canal cleaning and shaping involves eliminating microbes
and extracting infected pulp chamber contents while maintaining the root
canal’s structural integrity. Different file system have been suggested for primary teeth root canal preparation two of which are used in this study. The
primary objective of this study is to assess and compare the significant
difference in instrumentation time and obturation quality between exclusive
pediatric hand protaper i.e. Kedo-SH and fourth generation pediatric rotary
files i.e. Kedo S Square. |