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CTRI Number  CTRI/2023/09/057328 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 03/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Relation of quality of filling done in root canal of milk teeth(molars) seen in X-ray with pain that can happen after the procedure, using 3 different types of files,Kedo SH,Kedo S-square and Kedo S plus: A Randomised clinical trial 
Scientific Title of Study   Comparative association of Radiographic Quality of Obturation with Postoperative Pain in primary molars using Kedo-SH Files, Kedo-S Square Files and Kedo-S plus files: A Randomised clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjali anand 
Designation  junior resident 
Affiliation  King George Medical University 
Address  Gautam Buddha Hostel, King George medical university.
4th floor,Department of Paediatric and Preventive Dentistry,Faculty of Dental Sciences,King George Medical University,Lucknow, UP
Lucknow
UTTAR PRADESH
226003
India 
Phone  8604555971  
Fax    
Email  ms.anjali63@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajeev kumar singh 
Designation  Professor and head , Department of Paediatric and Preventive Dentistry 
Affiliation  King George Medical University 
Address  4th floor,Department of Paediatric and Preventive Dentistry,Faculty of Dental Sciences,King George Medical University,Lucknow,UP

Lucknow
UTTAR PRADESH
226003
India 
Phone  9450849528  
Fax    
Email  rajkids2000@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anjali anand 
Designation  junior resident 
Affiliation  KING GEORGE MEDICAL UNIVERSITY 
Address  4th floor,Department of Paediatric and Preventive Dentistry,Faculty of Dental Sciences,King George Medical University,Lucknow,UP

Hardoi
UTTAR PRADESH
226003
India 
Phone  8604555971  
Fax    
Email  ms.anjali63@gmail.com  
 
Source of Monetary or Material Support  
Department of paediatric and preventive dentistry,FODS,king george medical university 
 
Primary Sponsor  
Name  Anjali anand 
Address  4th Floor, Department of Paediatric and Preventive Dentistry, Faculty of Dental Sciences, King Georges Medical University, UP,Lucknow 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anjali Anand  king george medical university  Department of paediatric and preventive dentistry,4th floor,New Dental Building
Lucknow
UTTAR PRADESH 
8604555971

ms.anjali63@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, King Georges Medical University, UP, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  compairing Kedo-SH file,Kedo- S square file,Kedo -S Plus file  To assess the radiographic quality of obturation and post operative pain using these three file systems at 6 hours, 24 hours, 72 hours, and 1 week 
Comparator Agent  Kedo-SH file,Kedo- S square file,Kedo -S Plus file   To compare association of radiographic quality of obturation with postoperative pain using different file systems 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Vital or non-vital Upper and lower deciduous molars without sinus tract
Without external or internal pathologic root resorption in teeth,
Existence of adequate coronal tooth structure to support stainless steel crown.
Primary molar with 2/3rd of root present 
 
ExclusionCriteria 
Details  Swelling
Excessive mobility
Cellulitis
Perforated pulpal floor
Fistula.
Children lacking cooperative ability, those having a systemic illness 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Immediate postoperative radiograph will be evaluated.
Quality of obturation.
Postoperative pain
 
Immediate postoperative radiograph 
 
Secondary Outcome  
Outcome  TimePoints 
post operative pain   pain will be evaluated at 6 hour,24 hour,72 hour,1 week 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
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)   14/09/2023 
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 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  

SUMMARY

The loss of primary dentition prematurely is a common problem that may prevent a normal eruption of succedaneous teeth, hamper esthetics, and lead to abnormal tongue habits.[1]The best space maintainer in primary dentition is the natural tooth itself.Despite various advances in the preventive methods against dental caries, it still remains as a potent threat for infants and children.[2] When the pulp has potential to recover after the irritation has been removed, conservative treatments are recommended.However, pulpectomy is recommended where there is evidence of chronic inflammation involving radicular pulp or pulp necrosis with or without periapical involvement.Due to the tortuous course of root canals of primary teeth, endodontic treatment is more challenging and time consuming with the use conventional hand files.[3]The complex root canal system of primary teeth plays a main part in the outcome of the treatment, which will affect the success of root canal therapy.Instrumentation of root canals is carried out with the primary objective to remove the infection,and this greatly determines the success of pulpectomy.Biomechanical preparation with rotary files in primary teeth has gained popularity when the first case was reported by Barr et al. using ProFile 0.04 taper permanent rotary instruments[4].In addition, pediatric patients have limited mouth opening and the longer length of adult rotary files makes it difficult for use.When the pulp has potential to recover after the irritation has been removed, conservative treatments are recommended. However, pulpectomy is recommended where there is evidence of chronic inflammation involving radicular pulp or pulp necrosis with or without periapical involvement.Endodontic treatment in primary teeth is challenging due to the anatomy and morphology of root canals. Complete biomechanical preparation of the canals provides a path for irrigants and also aids in sealing the canals with biocompatible obturating material while preserving the radicular anatomy.[5] The use of rotary instrumentation for cleaning and shaping of deciduous teeth was initially reported in 2000. It was found to be an efficient technique resulting in a uniform shape of canals with predictable obturation. Its ability to provide conical canals and decrease in canal preparation time favors its use.[6-10]In child patients, shorter appointment length is suggested to enhance cooperation.[11-12] Very few studies have been done comparing the different rotary file systems in primary teeth.Systematic clinical trials need to be conducted with rotary files in primary teeth to validate the results and to arrive at definitive conclusions.There are no in vivo studies done comparing the quality of obturation and pos oprative pain evaluation of Kedo-SH file and Kedo-S square Files and kedo-S plus in deciduous teeth. Therefore, this particular study will be conducted to compare and evaluate instrumentation time and quality of obturation of Kedo-Square and Kedo-s plus rotary files with kedo-SH hand files in primary molars.

AIM

Aim of the study is to compare the association of Radiographic Quality of Obturation with Postoperative Pain in primary molars using Kedo-SH Files, Kedo-S Square Files and Kedo-S plus files.


REVIEW OF LITERATURE

1.Rishi Tyagi et al.(2021) concluded that the clinical performance of pediatric and reciprocating files was superior then hand instrumented k-files.

2. Anmol Mathur et al.(2021) concluded that  Pediatric rotary files are efficient alternatives to hand instrumentation and can be considered as the standard of care in pulpectomies of primary teeth.

3. Neethu Ann Preethy et al.(2021)concluded that the quality of obturation in hand k-file, ProTaper Gold file and Kedo-SG Blue demonstrated almost a similar performance.

4. Lakshimi Lakshmanan et al.(2021) concluded that the use of rotary instruments contributed to a lower incidence and intensity of postoperative pain than did the hand instruments.

5. Manisha NAIR et al.(2018) concluded that least post-operative pain was found in Mtwo group followed by Kedo-S group and K-file group.

  REFERENCES

Bell RA, Dean JA, Mc Donald RE, et al. Managing the developing occlusion. In: Dentistry for the child and adolescent. 9th ed., Mosby Inc.; 2011. pp. 551–552.

Fuks AB, Eidelman E. Pulp therapy in the primary dentition. Curr Opin Dent. 1991 Oct;1(5):556-63.

Topçuoğlu G, Topçuoğlu HS, Delikan E, Aydınbelge M, Dogan S. Postoperative pain after root canal preparation with hand and rotary files in primary molar teeth. Pediatr Dent. 2017 May 15;39(3):192-6.

Barr ES, Kleier DJ, Barr NV. Use of nickel-titanium rotary files for root

canal preparation in primary teeth. Pediatr Dent 2000;22(1):77–78

 Siqueira JsF Jr., Araújo MC, Garcia PF, Fraga RC, Dantas CJ. Histological evaluation of the effectiveness of five instrumentation techniques for cleaning the apical third of root canals. J Endod 1997;23:499502.

Barr ES, Kleier DJ, Barr NV. Use of nickeltitanium rotary files for root canal preparation in primary teeth. AAPD 2000;22:778

 Pinheiro SL, Araujo G, Bincelli I, Cunha R, Bueno C. Evaluation of cleaning capacity and instrumentation time of manual, hybrid and rotary instrumentation techniques in primary molars. Int Endod J 2012;45:37985.

Kuo CI, Wang YL, Chang HH, Huang GF, Lin CP, Guo MK.Application of NiTi rotary files for pulpectomy in primary molars. J Dent Sci 2006;1:105

Silva LA, Leonardo MR, NelsonFilho P, Tanomaru JM.Comparison of rotary and manual instrumentation techniques on cleaning capacity and instrumentation time in deciduous molars. J Dent Child 2004;71:457

Govindaraju L, Jeevanandan G, Subramanian EM. Comparison of quality of obturation and instrumentation time using hand files and two rotary file systems in primary molars: A singleblinded randomized controlled trial. Eur J Dent 2017;11:3769.

Aminabadi NA, Oskouei SG, Farahani RM. Dental treatment duration as an indicator of the behavior of 3to 9yearold pediatric patients in clinical dental settings. J Contemp Dent Pract 2009;10:E02532.

Lenchner V. The effect of appointment length on behavior of the pedodontic patient and his attitude toward dentistry. J Dent Child 1966;33:6174

 
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