| CTRI Number |
CTRI/2024/06/068673 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pulp therapy of milk teeth with new rotary instruments. |
|
Scientific Title of Study
|
Comparative efficacy of two rotary single file systems in
pulpectomy of primary molars- A randomized clinical trial.
|
| 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 Minakshi Gogne |
| Designation |
PG Student |
| Affiliation |
SGT Dental College Hospital and Research Institute |
| Address |
Room no 6 Department of Pediatric and Preventive Dentistry Faculty of Dental Sciences SGT Dental College Hospital and Research Institute SGT University Budhera Gurugram Haryana
Gurgaon HARYANA 122505 India |
| Phone |
9654995089 |
| Fax |
|
| Email |
minakshigogne@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Anil Gupta |
| Designation |
HOD and Professor |
| Affiliation |
SGT University |
| Address |
Department of Pediatric and Preventive Dentistry,Faculty of Dental Sciences, SGT Dental College Hospital and Research Institute SGT University Budhera Gurugram Haryana
Gurgaon HARYANA 122505 India |
| Phone |
9899039805 |
| Fax |
|
| Email |
anil.gupta@sgtuniversity.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Minakshi Gogne |
| Designation |
PG Student |
| Affiliation |
SGT Dental College Hospital and Research Institute |
| Address |
Room no 6 Department of Pediatric and Preventive Dentistry Faculty of Dental Sciences SGT Dental College Hospital and Research Institute SGT University Budhera Gurugram Haryana
Gurgaon HARYANA 122505 India |
| Phone |
9654995089 |
| Fax |
|
| Email |
minakshigogne@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SGT Dental College Hospital and Research Institute Hospital SGT University Budhera Gurugram Haryana 122505 |
|
|
Primary Sponsor
|
| Name |
SGT University Gurugram Haryana |
| Address |
Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT Dental College Hospital and Research Institute SGT University Budhera Gurugram Haryana 122505 India
|
| 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 Minakshi Gogne |
SGT Dental College Hospital and Research Institute Hospital Gurugram Haryana |
Room no 6 Department of Pediatric and Preventive Dentistry Faculty of Dental Sciences SGT Dental College Hospital and Research Institute Hospital SGT University Budhera Gurugram Haryana Gurgaon HARYANA |
9654995089
minakshigogne@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee -SGT Dental College Hospital and Research Institute(IEC-SGTDCHRI) |
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 |
| Intervention |
Kedo Nano Plus(Sixth generation) |
Pulpectomy of primary molars will be done by using Kedo Nano Plus rotary single file system. |
| Comparator Agent |
Kedo-S Plus(Fifth generation) |
Pulpectomy of primary molars will be done by using Kedo-S Plus rotary single file system. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Children Aged 3-9 years
2. Primary molars which are indicated for pulpectomy procedure.
3. Minimum 2/3 rd of root length remaining.
4. Teeth must be restorable.
5. Single visit pulpectomy.
|
|
| ExclusionCriteria |
| Details |
1. Pulpal floor perforation
2. Excess tooth mobility or tooth near exfoliation stage
3. Teeth with internal or external resorption
4. Excessive root resorption involving more than half of root length
5. Teeth with sinus tract or abscess
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of time taken and quality of obturation for instrumentation between two types of rotary systems ,Kedo S Plus and Kedo Nano Plus.
|
Radiographic and clinical records will be taken at baseline, postoperative, 3 months,6 months and 12 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical & radiographic success of pulpectomy procedure. |
Evaluation of clinical & radiographic success will be done at 6 months & 12 months. |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/06/2024 |
| Date of Study Completion (India) |
11/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="1" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Publication in process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Pulpectomy has emerged as the preferred treatment modality over extraction, for primary teeth with irreversible pulpitis .While hand files have served as the traditional method for paediatric endodontics, rotary instruments offer advancements that can significantly impact treatment in terms of limited chair time thereby lesser operator fatigue, lesser risk of iatrogenic errors (like ledges, zipping canal perforations, etc ) improved canal shaping, reduced post operative pain . Owing to the shape memory and super elasticity of Nickel Titanium(NiTi) rotary files, the challenges faced during biomechanical preparation (BMP) of primary root canals, due to their complex tooth morphology, can now be addressed more effectively. The success of primary tooth pulpectomy relies on instrumentation technique. Recent research shows pediatric rotary systems can substantially shorten pulpectomy procedures. Consequently, rotary systems have contributed to the positive management of child behavior and acceptance towards such a complex and demanding procedure. Studies have also claimed that uniform BMP by pediatric NiTi rotary files has decreased post endodontic pain. The recent shift in paediatric endodontics from sequential multifile rotary systems to single-file systems has facilitated the implementation of single-visit pulpectomy procedures. This innovation is associated with improved obturation quality and enhanced treatment efficiency as measured by reduced operative time. One such file system is the Rotary KEDO-S File System which has been developed exclusively for pulpectomy of primary teeth. This rotary system has evolved over 6 generations The objective of our study is to compare KEDO-S PLUS (fifth generation) and KEDO NANO PLUS(sixth generation) rotary files systems. The KEDO-S PLUS instrument facilitates conservative canal shaping and minimizes the risk of iatrogenic apical perforation during root canal preparation. The most recent rotary single file system is the KEDO NANO PLUS (sixth generation). This heat treated single rotary file with nano carbon coating has a unique variably variable (VV) taper design which makes it a cutting edge rotary single file system. While many comparative studies have evaluated different paediatric rotary systems with manual K files, none of the studies have compared the efficacy of two different rotary single file systems till date. Also, parental attitudes towards dental procedures influence the behavior of the child undergoing dental treatment. Thus, the aim of our study is to evaluate the instrumentation time, quality of obturation and post-operative pain using two different single rotary file systems. We also aim to evaluate the association between parental anxiety and the child’s behavior during the pulpectomy procedure. |