| CTRI Number |
CTRI/2024/01/062122 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the quality of root filling, time of treatment and pain after treatment using three different cleaning systems |
|
Scientific Title of Study
|
Quality of obturation, instrumentation time and post-operative pain using three different file systems in primary teeth - 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 |
Shaik Sameera |
| Designation |
Post graduate student |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Paediatric and
Preventive Dentistry
Division-7
Room number-7
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Andhra pradesh
Nellore ANDHRA PRADESH 524003 India |
| Phone |
8919116647 |
| Fax |
|
| Email |
shaiksameera2407@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sivakumar Nuvvula |
| Designation |
Professor and Head of the Department |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Paediatric and
Preventive Dentistry
Division-7
Room number-7
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Andhra pradesh
Nellore ANDHRA PRADESH 524003 India |
| Phone |
9441624429 |
| Fax |
|
| Email |
dentist4kids@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr K V Saikiran |
| Designation |
Assistant Professor |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Paediatric and
Preventive Dentistry
Division-7
Room number-7
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Andhra pradesh
Nellore ANDHRA PRADESH 524003 India |
| Phone |
8125774535 |
| Fax |
|
| Email |
saikiran4u2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatric and
Preventive Dentistry
Division-7
Room number-7
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Andhra pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Shaik Sameera |
| Address |
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Andhra Pradesh |
| Type of Sponsor |
Other [Self sponsor] |
|
|
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 Shaik Sameera |
Narayana Dental College and Hospital |
Divivsion-7 Department of Paediatric and Preventive Dentistry
Nellore
Nellore ANDHRA PRADESH |
8919116647
shaiksameera2407@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Narayana Dental college and hospital |
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-SH and Pedo Flex file |
Kedo-SH hand file consists of P1, P2, and P3 stainless steel files and D1, E1, and U1 nickel–titanium files. The total length of the file is 16 mm with a flute length of 12 mm.
Pedo-Flex Files made of NITI, durable and high-temperature rebound memory with 16mm length and 4-6% taper. |
| Comparator Agent |
Manual K-files |
K files are the universal standard for canal negotiation, shaping, and recapitulation of root canal systems. They are generally used with a quarter turn “watch-winding†motion and vertical pull. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged between 4-9 years who needed endodontic treatment, who signed the consent form.
2.Patient’s having pain during night.
3.Absence of internal or external pathologic root resorption
4.Vital or nonvital teeth without sinus tract.
5.Presence of adequate coronal tooth structure to receive stainless steel crown.
|
|
| ExclusionCriteria |
| Details |
1.Children lacking cooperative ability.
2.Children with underlying systemic diseases.
3.Children with special health care needs.
4.Children using continuous medication or who had taken analgesics or anti-inflammatories up to 12 hours before the procedure were excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare quality of Obturation and Instrumentation time using different Rotary file systems with Manual Instrumentation in Primary teeth |
Post operative radiograph will be taken after obturation
Instrumentation time was recorded using stop watch |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare Post-Operative pain using different Rotary file systems with Manual Instrumentation in Primary teeth |
Pain assessment will be done after the procedure |
|
|
Target Sample Size
|
Total Sample Size="84" Sample Size from India="84"
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)
|
07/02/2024 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Pulpectomy is a
procedure involving complete removal of pulp tissue from the root canal space
in primary teeth followed by filling it with an inert resorbable material. Using
hand files for instrumentation of the primary root canals has been well
documented in the literature. There are certain potential limitations like
increased canal preparation time, uneven preparation of root canal space associated
with the use of hand files despite its widespread usage for the instrumentation
of primary root canals. To overcome the disadvantages of the manual
instrumentation and to preserve the tortuous root canal path of the primary
teeth, rotary instrumentation was introduced into paediatric dentistry. An
increasing volume of research acknowledges the significance of minimizing
postoperative pain in pediatric endodontics using motorized instrumentation and
specific pediatric rotary files. Hence, the present study intends to compare
the quality of obturation, instrumentation time and intensity of postoperative
pain using manual instrumentation and rotary instrumentation.
Aim: The
aim of the study is to evaluate the quality of obturation, instrumentation time
and postoperative pain using pedoflex file, kedo-SH, and reciprocating hand
K-files in primary teeth. Objectives: To
compare the quality of obturation, instrumentation time and postoperative pain
during root canal preparation.
To evaluate the obturation quality,
instrumentation time during root canal preparation and intensity of
postoperative pain after pulpectomy in primary teeth employing manual
instrumentation(k-file) and rotary instrumentation (pedo flex file and kedo-SH
file)
The randomized clinical trial was carried out in the Department of
Paediatric and Preventive Dentistry,
Narayana Dental College and hospital, Nellore. The
informed consent was obtained from the
parents of the children who participated in the study.
Children between 4-9 years of age requiring pulpectomy were randomly
selected and allotted
to one of the three groups according to the computer generated
randomization sequence where instrumentation was done using: Group
1: Manual K-files (15-30) (Mani); Group 2: Pedo Flex file; Group 3: Kedo-SH. The
working length was determined with the pre-operative radiograph using Ingle’s radiographic
method. Local anesthesia was administered using 2% lignocaine with 1:2,00,000
adrenaline. The tooth indicated for pulpectomy was isolated using rubber dam. Using
No.6 round bur (Mani) was used in a high speed hand piece to remove the
superficial caries and No.330 pear shaper bur (Mani) was used to completely
de-roof thepulp chamber. No.10 size K file (Mani) was used to determine the
patency of the canals. The canal preparation was done using: Group
1: Twenty eight teeth were instrumented using K-files from size 15 to size 30 (Mani) in quarter pull turn method, Group
2: Twenty-eight teeth were instrumented using Pedo Flex file, Group 3: Twenty-eight
teeth were instrumented using Kedo-SH file. The time taken for the
instrumentation of the canals was recorded in seconds using a stop watch by an assistant. The
canals were then irrigated and obturated. A postobturation radiograph was taken
to assess the quality of obturation. Pain assessment is done using Memoji’s
pain scale.
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