FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/04/085949 [Registered on: 29/04/2025] Trial Registered Prospectively
Last Modified On: 27/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Endodontic treatment outcome after using rotary vs reciprocating file system  
Scientific Title of Study   Assessment of endodontic treatment outcome by using single rotary file vs single reciprocating file with single cone obturation: 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 Pranjali Babre 
Designation  PG Resident 
Affiliation  SMBT Institute of Dental Sciences and Research, Nashik 
Address  SMBT Institute of Dental Sciences and Research, Nashik Department- Conservative Dentistry and Endodontics Room no- 201

Nashik
MAHARASHTRA
422403
India 
Phone  9370231866  
Fax    
Email  pranjalibabre98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aarti Bohora 
Designation  Professor and PG guide 
Affiliation  Professor at SMBT Institute of Dental Sciences and Research, Nashik 
Address  SMBT Institute of Dental Sciences and Research, Nashik Department- Conservative Dentistry and Endodontics Room no- 201

Nashik
MAHARASHTRA
422403
India 
Phone  9766787431  
Fax    
Email  draab.endo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pranjali Babre 
Designation  PG Resident 
Affiliation  SMBT Institute of Dental Sciences and Research, Nashik 
Address  SMBT Institute of Dental Sciences and Research, Nashik Department- Conservative Dentistry and Endodontics Room no- 201

Nashik
MAHARASHTRA
422403
India 
Phone  9370231866  
Fax    
Email  pranjalibabre98@gmail.com  
 
Source of Monetary or Material Support  
SMBT Institute of Dental Sciences and Research, Nandihills, Igatpuri, Dhamangaon, District -Nashik Pin code- 422403 Country- India 
 
Primary Sponsor  
Name  Dr Pranjali Babre 
Address  SMBT Institute of Dental Sciences and Research, Nandihills, Igatpuri, Dhamangaon, District -Nashik Pin code- 422403 Country- India 
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 Pranjali Babre  SMBT IDSR , Nashik  Department/division- Conservative Dentistry and Endodontics Room no- 201
Nashik
MAHARASHTRA 
9370231866

pranjalibabre98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of SMBT IDSR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Individuals systemically healthy, with dental caries in lower premolars. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Trunatomy Dentsply rotary file system  Rotary file systems harness the power of continuous rotational motion to navigate the complex terrain of root canals with unparalleled ease and effectiveness. These instruments are engineered to gradually taper, allowing for meticulous debris removal and precise shaping while minimizing the risk of procedural complication 
Intervention  WaveOne gold Dentsply reciprocating file system  This reciprocating file systems introduce a dynamic back-and-forth motion, enhancing safety and instrument longevity without compromising efficiency. This unique reciprocating action mitigates the risk of file separation and reduces torsional stress, promoting a more controlled and predictable instrumentation process. It is used in a slow in and out pecking motion combined with a brushing motion. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Single rooted single canal mandibular premolars
2. Cases of apical periodontitis and irreversible pulpitis
3. Patients with PAI score ranging from 1 to 3
4. Patients of all the genders aged 18 to 60 years
5. Patients without systemic diseases 
 
ExclusionCriteria 
Details  1. Teeth with root caries cystic radiolucency calcified canals or resorption retreatment cases
2. Teeth with poor periodontal health
3. Patients with multimorbidity and pregnant patients
4. Patients with lack of compliance
5. Patients who consumed analgesics before 12 to 24 hrs prior to the root canal treatment and 24 hrs after treatment 
 
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 
The expected outcome of the study could provide valuable insights into the efficiency of rotary and reciprocating file system and their effect on microbial count, postoperative pain. If one treatment option demonstrates superior clinical and radiographic outcome by choosing the more successful treatment option dental professionals can potentially reduce the need for more time taking technique and ease the operation for clinicians and comfort level of patients as well  At 4hrs 8hrs 12hrs 24hrs and 48hrs and 1week intervals 
 
Secondary Outcome  
Outcome  TimePoints 
The expected outcome of the study could provide valuable insights into the efficiency of rotary and reciprocating file system and their effect on The expected outcome of the study could provide valuable insights into the efficiency of rotary and reciprocating file system and their effect on apical healing   6 Months 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 2 
Date of First Enrollment (India)   13/05/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Title- Assessment of endodontic treatment outcome by using single rotary file vs single reciprocating file with single cone obturation a randomized clinical trial

 

Null Hypothesis-  There is no difference in effectiveness on endodontic treatment outcome by using single rotary file vs single reciprocating file using single cone obturation

Other Hypothesis- There is a difference in effectiveness on endodontic treatment outcome by using single rotary file vs single reciprocating file using single cone obturation

Primary Objectives

1 To assess the preoperative microbial load in single rotary file vs single reciprocating file

2 To assess the the microbial load postoperative pain and apical healing in single rotary file and single reciprocating file postendodontic treatment

Other Objectives 

1 To compare the apical healing and postoperative pain between single rotary file and single reciprocating file after the endodontic treatment

2 To compare the preoperative and postoperative microbial load between single rotary file and single reciprocating file

Methodology 

Study design A randomized clinical trial

II Study population Teeth with apical periodontitis irreversible pulpitis in healthy cooperative patients aged 18 to 60 years

X) Method

Informed consent will be obtained from the patients after explaining the details of the study 

Total sample size is 64 single rooted mandibular premolars with single canals 

Preoperative radiographs of the selected teeth will be taken to ensure the inclusion criteria 

After the application of rubber dam access cavity will be prepared maintaining the isolation and once the pulp tissue is extirpated 10 K file will be used to determine the working length using apex locator and later on it will be confirmed with a periapical radiograph

The initial sample pre instrumentation P1will be obtained by placing 10 size sterile absorbent paper point inside the selected canal for 1 minute and stored in sterile Eppendorf tube containing 1 ml of thioglycolate broth

Later the canal patency will be established Subsequently the canal will be prepared with different file systems according to the groups assigned

Based on computer generated randomization and sequentially numbered opaque sealed envelope method the teeth will be randomly assigned to two groups of n equals to 32 teeth each

Group A -Trunatomy Dentsply rotary file system

Trunatomy files will be used in the following order orifice Modifier Glider and Prime File  as per manufacturers instruction.

Group B- WaveOne gold Dentsply reciprocating file system

The canals will be instrumented using files as per the manufacturers instruction

Cleaning and shaping of the teeth will be carried out with the respective allotted file system using 17 percent  EDTA, 2.5 percent NaOCl and saline irrigation  Once the cleaning and shaping is completed calcium hydroxide dressing will be given and the teeth will be sealed with cotton and temporary restoration and the patient will be recalled after 7 days for obturation

Patients will be prescribed anti inflammatory as needed

After the 7 days duration the intracanal medicament dressing will be removed and the final sample post instrumentation P2 will be taken from the canals to compare and evaluate the microbial load

Once the sample is collected the procedure will be completed by irrigation with EDTA NaOCl and activated irrigation The canal will be then dried using paper points and obturated using bioceramic sealer with single cone obturation technique. The tooth will then be temporarily sealed

Post operative angled radiographs will be taken to check the quality of the endodontic treatment

Postoperative pain will be evaluated with VAS

Data on pain will be recorded by the patients at 4hr 8hr 12hr 24hr  and 48hr and 1week intervals

The patients will be instructed to take mild analgesics 400 mg of ibuprofen in case of pain Patients taking 400 mg of ibuprofen during the first 24 h in each group will be considered to have moderate pain at  4hr 8hr 12hr intervals

Patients taking more than 400 mg of ibuprofen during the first 24 hr and those taking any dose of the medicine after 24 hr will be excluded from the study

Post operative evaluation of the apical healing will be checked after 6 months by taking radiographs and the periapical index PAI scoring system by  Orstavik et al 1986 with its 5 point radiographic reference scale to score the absence presence and increasing severity of periapical disease

 
Close