| CTRI Number |
CTRI/2025/05/086692 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of working length determination |
|
Scientific Title of Study
|
Evaluation of accuracy of root canal working length determination methods and their effect on quality of obturation and post operative pain following pulpectomy in primary molars- A comparative randomised 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 GIRISH BABU KL |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Hassan Institute of Medical sciences |
| Address |
Department of Dentistry,
Hassan
KARNATAKA
573201
India |
| Phone |
09845340753 |
| Fax |
|
| Email |
docgirish77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GIRISH BABU KL |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Hassan Institute of Medical sciences |
| Address |
Department of Dentistry,
Hassan
KARNATAKA
573201
India |
| Phone |
09845340753 |
| Fax |
|
| Email |
docgirish77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GIRISH BABU KL |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Hassan Institute of Medical sciences |
| Address |
Department of Dentistry,
Hassan
KARNATAKA
573201
India |
| Phone |
09845340753 |
| Fax |
|
| Email |
docgirish77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dentistry, Hassan Institute of Medical Sciences, Hassan-573201 |
|
|
Primary Sponsor
|
| Name |
Girish Babu KL |
| Address |
Department of Dentistry,
Hassan Institute of Medical Sciences, Hassan-573201 |
| Type of Sponsor |
Other [NIL] |
|
|
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 Girish BAbu KL |
Hassan Institute of Medical Sciences |
Room no:20, Department of Dentistry,
Hassan
KARNATAKA |
9845340753
docgirish77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- HIMS,Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal, healthy children aged 4-9 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional Radiography (Confident Dental Equipment Ltd, New Life Radiology, Italy) |
Working length will be determined by using Conventional Radiography and its there effect on the quality of obturation and post-operative pain |
| Comparator Agent |
Digital Radiovisiography (Vista Scan Mini Plus, Dürr Dental; Bietigheim-Bissingen, Germany) |
Working length will be determined by using Digital Radiovisiography and its there effect on the quality of obturation and post-operative pain |
| Comparator Agent |
Electronic Apex Locator (Root ZX II; J. Morita, Tokyo, Japan) |
Working length will be determined by using Electronic apex locator and its there effect on the quality of obturation and post-operative pain |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children with primary molars with 1. Necrotic pulp 2. Irreversible pulpitis symptoms 3. Radiolucent areas in the furcation or periapical region, and 4. At least two-thirds of each root remaining |
|
| ExclusionCriteria |
| Details |
Children with primary molars with 1. Structures inadequate for restoration 2. Clinical evidence of pulp pathology (resorption, spontaneous pain, tenderness to percussion/palpation, swelling (intraoral/extraoral) sinus tract, pathological mobility) 3. Perforated pulpal floor 4. Internal or external pathological root resorption 5. Dilacerated roots 6. Calcified/obliterated root canals and 7. Evidence of root fracture. 8. Children requiring special health care needs, with limited or lacking cooperative abilities, or requiring sedation/general anaesthesia for behaviour management and allergy to local anaesthetics and any other drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of working length determination of on quality of obturation,post-operative pain, obturation techniques and outcome of pulpectomized teeth |
At end of the intervention for quality of obturation and for the assessment of pain - 6hr, 12, 24, 48, and 72 hours, and at one week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of working length determination methods on technique of obturation & quality of obturation with & without coronal flaring |
At end of the intervention for quality of obturation & for the assessment of pain - 6hr, 12, 24, 48, & 72 hours, & at one week |
|
|
Target Sample Size
|
Total Sample Size="750"
Sample Size from India="750"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/05/2025 |
| 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="3"
Months="0"
Days="0" |
|
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
|
A single operator (GB) with
clinical experience of more than 20 years will be conducting the pulpectomy
procedure in a single appointment except working length determination of the
root canals. The study will comprise 128 teeth (384 root canals) from the
selected children. Pulpectomy of all the teeth will be done under local
anaesthesia. The traditional access cavity of the teeth will be performed and
the pulp tissue from the pulp chamber will be removed using a sterile sharp
spoon excavator. Straight-line access will be obtained and pulp tissue will be
extirpated from the root canal using H-files. The patency of the root canal
will be assessed using a #10 K-file.25
Following, the working
length of the root canals of all the 128 teeth will be determined by selected
three methods: i.e., conventional radiography, digital radiovisiography and an
electronic apex locator. The mean values of the
working length taken by 3 methods will be recorded by subtracting 1mm from the
length that measured. Measurements of root canal lengths estimated from
conventional radiography, intraoral digital radiovisiography and electronic
apex locator will be compared with the actual root canal length of the
extracted molars obtained using stereomicroscope. In all the
3 groups, the chemo-mechanical preparation of the root canals will be done with
a pediatric rotary file system (Kedo-SG file system -Reeganz Dental Care Pvt.
Ltd, India). The
root canals of all teeth will be intermittently irrigated with saline. Endoflas® cement
will be used as obturating material in all the groups. Rotary #25 lentulospiral
method will be used for obturation of teeth. Following, the teeth will be
restored with stainless steel crown within one week of obturation and quality of obturation, quality of obturation according to the type of obturation technique used, quality of obturation with and without coronal preflaring and post-operative pain in single and multivisit pulpectomy will be assessed. All
the patients will be recalled at 3, 6, 9 and 12, 18 and 24 months for
evaluation of clinical and radiographic success of pulpectomized teeth. Statistical analysis: Statistical Package for Social Sciences
[SPSS] for Windows Version 22.0 Released 2013. Armonk, NY: IBM Corp. will be
used to perform statistical analyses.
|