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CTRI Number  CTRI/2024/02/062822 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 14/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of different apical preparation sizes and taper on outcome of root canal treatment 
Scientific Title of Study   Effect of different apical preparation sizes and taper on outcome of primary orthograde endodontic treatment assessed using CBCT - 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 Kaadhambari S 
Designation  Post Graduate student 
Affiliation  R.V..S Dental College and Hospital  
Address  Room No -7b Department of conservative dentistry and endodontics, R.V.S Dental College and Hospital , Sulur
R.V.S.Dental College and Hospital, Sulur
Coimbatore
TAMIL NADU
641402
India 
Phone  9095958998  
Fax    
Email  kaadha98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sibi Swamy 
Designation  Reader (M.D.S) 
Affiliation  R.V..S Dental College and Hospital  
Address  Room No 7b,Department of Conservative Dentistry and Endodontics, R.V.S Dental College and Hospital ,Sulur, Coimbatore
R.V.S.Dental College and Hospital, Sulur
Coimbatore
TAMIL NADU
641402
India 
Phone  7811808888  
Fax    
Email  drsibiswamy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kaadhambari S 
Designation  Post Graduate student 
Affiliation  R.V..S Dental College and Hospital  
Address  Room No 7b,Department of Conservative Dentistry and Endodontics,R.V.S Dental College and Hospital , Sulur,Coimbatore
R.V.S.Dental College and Hospital, Sulur
Coimbatore
TAMIL NADU
641402
India 
Phone  9095958998  
Fax    
Email  kaadha98@gmail.com  
 
Source of Monetary or Material Support  
R.V.S Dental College and Hospital ,Sulur,Coimbatore 641 402 
 
Primary Sponsor  
Name  Dr Kaadhambari S 
Address  R.V.S. Dental College and Hospital 
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 
Dr Kaadhambari S  R.V.S Dental College and Hospital  Room No -7b, Department of Conservative Dentistry and Endodontics.
Coimbatore
TAMIL NADU 
9095958998

kaadha98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
R.V.S INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K045||Chronic apical periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Effect of apical preparation size of # 30,0.06% taper  Duration - 6 months 
Intervention  Effect of apical preparation size of #25 0.04 taper  Duration - 6 months 
Intervention  Effect of apical preparation size of #25 0.06% taper  Duration - 6 months 
Intervention  Effect of apical preparation size of #30 0.04% taper  Duration - 6 months 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Those who are able to provide informed consent
2.Mature permanent teeth
3.Carious mandibular molars with asymptomatic apical periodontitis
4.Radiographic evidence of periapical lesion in mesial root of mandibular first molars 
 
ExclusionCriteria 
Details  1.Allergies to local anaesthetics or sulphites.
2.Below the age of 18 years.
3.History of significant medical conditions.
4.Teeth with cracks,fractures,endo perio lesion, periapical abscess,furcation involvement.
5.Teeth with more than two canals in mesial root of mandibular molars.
6.Pregnant women.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Reduction in size of the periapical lesion after root canal treatment with the different apical preparation sizes and taper  at baseline and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 4 
Date of First Enrollment (India)   24/02/2024 
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 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  

After confirming the eligibility , the patients will be informed about the study design, the clinical procedure involved, and the associated risks.They will be  ensured that root canal treatment will be performed regardless of whether they decided to participate in the study or not. Once the patient agreed to participate, verbal and written consent will be obtained, and the patient will be randomly assigned to 1 of the 4 designated groups. Randomization will be developed to eliminate any bias on the part of the investigators and to balance the number of patients between the treatment protocol types.The clinical and CBCT findings will be verified before the Root Canal Treatment.

Clinical Procedure

After the administration of local anesthesia (Lignocaine HCl with 2% adrenaline 1:80,000 (Lignox 2% A,Indoco Warren) caries will be excavated, and the access cavity will be  prepared under rubber dam isolation. The working length will be determined with the help of an electronic apex locator (Coltene Whaledent Private LTD) and will be confirmed with straight and angled radiographs. Then canals will be prepared using the step-back technique with 0.02% taper ISO stainless steel hand files.The apical preparation will be done with No.25,0.04% ; No.25,0.06% ; No.30,0.04% ; No.30,0.06% rotary files ( Hyflex CM) in groups A,B,C,D respectively and it will be accompanied by irrigation with 5 mL of  5.25% NaOCl (Prime Dental product Private Ltd, INDIA)  after each instrumentation cycle. Canal patency will be  ensured by passing a #10 stainless steel file approximately 0.5 to 1.0 mm beyond the working length. After enlarging, the canals will be  irrigated with 5 mL  of 17% EDTA for 1 minute. After drying with sterile absorbent points, the canals will be  filled with paste made by mixing calcium hydroxide powder  with 2% chlorhexidine liquid  using a lentulo spiral. The tooth will  then temporarily restored with Intermediate Restorative Material (Prime Dental product Private Ltd, INDIA).  The patient will be recalled after 1 week. At the next appointment, the paste will be removed with the help of XP Endo Finisher and copious irrigation with 5.25% NaOCl followed by a final rinse of 5.0 mL 17% EDTA. If the patient is asympomatic then the canals be obturated with gutta-percha and bioceramic sealer(CERASEAL, MetaBiomed,Europe) using lateral condensation technique, if the patient is symptomatic the canals will be cleaned and shaped and the intracanal medicament will be placed again and patient will be recalled again after 1 week . After obturation, the access cavity will be  restored. An immediate postoperative radiograph will be taken using preset exposure parameters and will be processed manually. Follow-up examinations will be performed after 6  months and it consists of history taking and clinical and CBCT examination.

 


 
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