Comparison of Obturation Quality and Lateral Canal Fill (by Sealer): Ultrasonic-Activated Versus Non-Ultrasonic Conventional Irrigation Techniques in Root Canal Treatment - A Randomized Controlled Trial
Phase: NA
Conditions: Comparison Between Two Type of Irrigation Systems
Sponsor: Prime Foundation

 
Comparison of Quality of Obturation and Lateral Canal Fill (by 
Sealer) : Ultrasonic Activated versus Non-Ultrasonic Conventional 
Irrigation Techniques in Root Canal Treatment: A Randomized 
Controlled Trial  
 
  
  
  
  
  
  
  
  
  
Dated: April 30, 2024  
INTRODUCTION  
Root canal therapy (RCT) stands as the primary treatment modality for pulpal and periapical 
diseases [1]. An indispensable facet of  Root canal therapy  involves the meticulous processes of 
cleaning, shaping, and subsequent obturation of the root canal system, establishing a robust and 
impermeable seal [1,2]. The prognosis of Root canal therapy hinges upon various factors, including 
irrigation techniques and the technical proficiency of the root filling [3].  
Throughout its evolution, root canal irrigation has seen diverse methodologies employed to 
effectively disinfect the root canal space. Traditionally, techniques such as syringe irrigation and 
passive ultrasonic irrigation have been prevalent [4]. However, the introduction of ultrasonic 
activation irrigation systems has added a dynamic dimension, utilizing ultrasonic energy to 
augment irrigant flow and disrupt biofilms. Root canal irrigation plays a pivotal role in 
Endodontics, facilitating instrumentation through lubrication, removal of debris, microorganisms, 
smear layer, and preventing apical debris packing. Irrigants exert their effects through mechanical, 
chemical, and biological actions [5].  
Activated irrigation involves agitating and enhancing the flow of irrigants into the intricacies of 
the root canal system using mechanical or other energy forms. Unlike conventional irrigation, 
which relies solely on positive pressure and the viscosity of the irrigant for flow in the root canal 
system [5,6], various mechanical irrigant activation systems are available. These include ultrasonic 
activation using high or low frequency (e.g., EndoActivator), continuous ultrasonic irrigation 
(CUI), special holding devices during ultrasonics like Nusstein’s needle holding device, sonic 
energy (RispiSonic file), vibrations (Vibringe), passive ultrasonic irrigation (PUI-IrriSafe), and 
positive or negative pressure alternating devices (EndoVac, RinsEndo), or manual agitation of   

 
Comparison of Quality of Obturation and Lateral Canal Fill (by 
Sealer) : Ultrasonic Activated versus Non-Ultrasonic Conventional 
Irrigation Techniques in Root Canal Treatment: A Randomized 
Controlled Trial  
 
  
  
  
  
  
  
  
  
  
Dated:April 30, 2024  
  
the irrigant with high amplitude/frequency (MDA) [5-7]. The efficacy of irrigation depends on both 
the mode of delivery and the irrigant itself [5].  
The primary objective of root canal obturation is to achieve a fluid-tight seal to prevent future 
microbial contamination [8]. Obturation quality encompasses the length of the filling, density of the 
filling material, and the absence of voids [9]. The significance of achieving high-quality obturation 
cannot be overstated, directly impacting the prevention of microbial ingress and reinfection. Poor 
obturation may lead to treatment failure, necessitating retreatment and underscoring the importance 
of a comprehensive understanding of factors influencing obturation quality [10,11].  
Studies, such as the one by Chen S et al., have compared ultrasonic irrigation with syringe 
irrigation, revealing a higher incidence of lateral canal fill with ultrasonic irrigation (27% vs. 7% 
in syringe irrigation) [12]. Another study found no statistical difference in irrigant penetration in the 
main canal compared to control, passive ultrasonic irrigation, continuous ultrasonic irrigation, and 
easy clean groups [13]. Yet, a study  demonstrated a significant difference in radiographic healing 
rates among three groups (χ2=12.29, p=0.05), with higher healing rates observed in the Passive 
ultrasonic irrigation group (36.8%) and Laser activated irrigation group (42.1%) compared to the 
Conventional Syringe irrigation group (10.5%) [14].  
While many studies have explored outcomes such as post-operative pain, periapical healing, 
antibacterial efficacy, canal cleanliness, debridement efficacy, and delivery up to working length, 
limited research has directly compared obturation results between irrigation methods. Given the 
scarcity of data on this outcome and the direct impact of irrigation technique on the obturation 
quality and  lateral canal fill, a systematic investigation is warranted. This study aims to address   

 
  
Comparison of Quality of Obturation and Lateral Canal Fill (by 
Sealer) : Ultrasonic Activated versus Non-Ultrasonic Conventional 
Irrigation Techniques in Root Canal Treatment: A Randomized 
Controlled Trial  
 
  
  
  
  
  
  
  
  
  
  
Dated:April 30, 2024  
this gap, contributing to the existing knowledge base and guiding clinicians in optimizing their 
endodontic procedures.  
OBJECTIVE  
To compare the quality of  Obturation  and lateral canal fill (by sealer) during root canal treatment 
between two irrigation techniques—ultrasonic activated irrigation and non-ultrasonic 
conventional irrigation  
OPERATIONAL DEFINITIONS  
Obturation Quality and Lateral canal fill       
It will include assessing the length of the root canal filling of  main canals, evaluating the density 
of the filling material, determining the taper of root canal filling, and accessing the lateral canal 
fill by sealer  by post- operative radiographs. The radiographs will be evaluated independently by 
two senior endodontists. A scoring system will be employed and each of three components will be 
given a score of 0 and 1 with higher scores indicating better obturation quality (Table 1, 2 and 3).  
  
  
  
  
  

 
Comparison of Quality of Obturation and Lateral Canal Fill (by 
Sealer) : Ultrasonic Activated versus Non-Ultrasonic Conventional 
Irrigation Techniques in Root Canal Treatment: A Randomized 
Controlled Trial  
 
  
  
  
  
  
  
  
  
  
  
Dated:April 30, 2024  
Table 1. Parameters used to evaluate and score the quality of RCTs  
Parameters  
Criteria  
Definition  
Length of root canal filling  
Adequate(=1)  
Root filling ending ≤ 2 mm from  
the radio-graphic арех  
  
  
Inadequate(=0)  
Overfilled: root filling extruded  
beyond the radio- graphic apex  
Under-filled: root filling ≥2 mm  
from the radio- graphic apex  
Density of root canal filling  
Adequate(=1)  
Correct  
density  
of  
filling  
 
 
material and no voids present in
the root filling nor between root
filling and root canal walls  
Inadequate(=0)  
Low density of filling material  
 
 
and/or voids present in the root
filling or between root filling and
root canal walls  
Taper of root canal filling  
Adequate(=1)  
Consistent  taper  from  the
 
coronal to the apical part of the 
filling  

 
Inadequate(=0)  
No consistent taper from the  
 
coronal to the apical part of the 
filling  
  
  
Table 2  
T-Score  
Score 3  
Obturated canals have all three qualities of ideal Obturation.  
 
Adequately filled (with in 2mm from radiographic apex). 
Smooth coronal apical taper. No voids  
Score 2  
Obturated canals have any two qualities of ideal obturation.  
Score 1  
Obturated canals have any one quality of ideal obturation.   
Scorre o  
Obturated canals have no quality of ideal obturations  
  
Lateral canal :   
A type of accessory canal located in the coronal or middle third of the root, usually extending 
horizontally from the main canal  space.  
Table 3  
 Parameters used to evaluate and score of lateral canal fill  
Score 1  
Adequete  
Lateral canals were filled with   
Score 0  
Inadequte  
Lateral canals were not filled  
  
Non-Ultrasonic Conventional Irrigation  
  

 
Comparison of Quality of Obturation and Lateral Canal Fill (by 
Sealer) : Ultrasonic Activated versus Non-Ultrasonic Conventional 
Irrigation Techniques in Root Canal Treatment: A Randomized 
Controlled Trial  
 
  
  
  
  
  
  
  
  
  
  
Dated:April 30, 2024  
This group involves the application of irrigating solutions through syringes or irrigation needles 
during the root canal procedure. 5 ml of 3% sodium hypochlorite (NaOCl) solution will be 
introduced into each canal via 5cc syringes.  
Ultrasonic Activated Irrigation Technique  
This group involves the use of ultrasonic device to agitate and activate irrigating solutions within 
the root canal.VAT-3 ultrasonic activator high frequency device (45KHz± 5kHz) [Refine] will be 
used for this study and 3% sodium hypochlorite (NaOCl) solution will be used for irrigation.  
HYPOTHESIS  
There is a difference in obturation quality and  lateral canal fill between ultrasonic activated 
irrigation results as compared to conventional irrigation technique in root canal treatment.  
MATERIAL AND METHOD  
STUDY DESIGN: Double Blinded Randomized Controlled Trial  
STUDY SETTING: Operative Dentistry and Endodontics, Peshawar Dental College Peshawar  
DURATION OF STUDY: Minimum six months, after the synopsis approval  
SAMPLING METHOD: Non-Probability Consecutive Sampling  
SAMPLE SIZE: Sample size is calculated using WHO calculator keeping 5% level of 
significance, 90 % power of test, based on reference study, 27% of sampled population achieved 
adequate obturation and lateral fill of canals in ultrasonic activated irrigation group as compared   
  

 
Comparison of Quality of Obturation and Lateral Canal Fill (by 
Sealer) : Ultrasonic Activated versus Non-Ultrasonic Conventional 
Irrigation Techniques in Root Canal Treatment: A Randomized 
Controlled Trial  
 
  
  
  
  
  
  
  
  
  
  
Dated:April 30, 2024  
to conventional non irrigation group which was 7%  as shown in (table 4) [12]. Expected sample 
size is 59 participants in each group, total 118 patients.  
  
SAMPLE SELECTION:  
Inclusion Criteria:  
• 
Both male and female   
• 
Age Group: Adults (18-70) Years  
• 
Patients presenting with pain and sensitivity in the mandibular molars and are advised 
root canal treatment at our institute after examination and Xray  
Exclusion Criteria:  
• 
Teeth with complex root canal anatomy that may complicate the obturation process.  
• 
Pregnancy   
• 
Medically compromised patient including those with uncontrolled diabetes, 
cardiovascular diseases, immunodeficiency disorders, bleeding disorders,  and severe 
respiratory diseases  
• 
Patients who refused to participate in this study.  

Comparison of Quality of Obturation and Lateral Canal Fill (by 
Sealer)  
: Ultrasonic Activated versus Non-Ultrasonic Conventional 
Irrigation Techniques in Root Canal Treatment: A Randomized  
  
Controlled Trial 
  
  
  
  
  
  
  
  
  
Dated:April 30, 2024  
DATA COLLECTION PROCEDURE:  
Ethical approval will be obtained from institutional research board of the hospital. Synopsis will 
be submitted for approval by CPSP. Once approved, patients will then be recruited from the 
endodontics department of Peshawar dental college who presents complaining of pain and 
sensitivity in the mandibular teeth and are candidates for RCT after dental examination and Xray 
teeth. Patients who get enrolled in the study will be screened for eligibility using the inclusion and 
exclusion criteria.This will be a double blinded study (the participant and the outcome assessor 
both will be kept blind).  A written informed consent will be taken after explaining the purpose of 
study and will be given the opportunity to ask any questions they may have about the study. 
Demographic data regarding age, gender, will be noted. Similarly, additional information about 
the specific tooth under consideration, will be documented. After randomization into either the 
Non-Ultrasonic Conventional Irrigation or Ultrasonic Activated Irrigation group via block 
randomization, pre-operative radiographs will be taken to establish baseline conditions. A block 
size of 6 will be used to ensure equal allocation of participants into each group. The root canal 
treatment is then performed as per the assigned group, with conventional irrigation involving the 
use of syringes and 3% sodium hypochlorite solution and Tg Sealer  for the Non-Ultrasonic 
Conventional Irrigation group, and the utilization of theVAT-3 ultrasonic activator high frequency 
device (45KHz± 5kHz) [Refine]  for the Ultrasonic Activated Irrigation group and same solution 
of 3% sodium hypochlorite and Tg Sealer will be used. Post-operative radiographs will be 
obtained to assess the obturation quality and lateral canal fill. A detailed radiographic proforma 

Comparison of Quality of Obturation and Lateral Canal Fill (by 
Sealer)  
: Ultrasonic Activated versus Non-Ultrasonic Conventional 
Irrigation Techniques in Root Canal Treatment: A Randomized  
  
will be employed to evaluate the length, density, taper of the root canal filling, and lateral canal 
fill . Each of these components will be scored individually, and an overall  
Obturation Quality Score is calculated by summing these scores. Care will be taken in the   
Controlled Trial 
  
  
  
  
  
  
  
  
  
Dated:April 30, 2024  
  
documentation of information so that information bias is reduced. All these information and other 
demographic will also be recorded into a predesigned proforma. Throughout the data  collection 
process, the research team will maintain strict adherence to data protection and confidentiality 
guidelines.  
DATA ANALYSIS PROCEDURE   
Data will be analyzed by using statistical package for social sciences (SPSS) version 25. Mean + 
SD will be measured for numerical data i.e age of the patient. Normality of the data will be 
calculated  by Shappiro Wilk test and Non-normal data will be presented as median (IQR). 
Frequencies and percentages will be measured for categorical data i.e gender, residence, 
socioeconomic status, type of tooth (Molars), side of tooth, teeth involved (Mandibular), and 
categorization of obturation score. Lateral canal Fill quality will be compared in each group by 
using the chi-square or fischer exact  test, keeping p-value < 0.05 as significant. Effect modifiers 
i.e age, gender, side of tooth and tooth involved will be controlled through stratification. Post 
stratification chi-square or fischer exact test will be performed by keeping the p-value < 0.05 
considered as significant.  

Comparison of Quality of Obturation and Lateral Canal Fill (by 
Sealer)  
: Ultrasonic Activated versus Non-Ultrasonic Conventional 
Irrigation Techniques in Root Canal Treatment: A Randomized  
  
REFERENCES:  
1. Karamifar K, Tondari A, Saghiri MA. Endodontic Periapical Lesion: An Overview on the 
Etiology, Diagnosis and Current Treatment Modalities. Eur Endod J. 2020;5(2):54-67.  
2. Şanal Çikman A, Köse TE, Günaçar DN, Çene E, Arıcıoğlu B. Evaluation of 
endodontically treated teeth and related apical periodontitis using periapical and   
Controlled Trial 
  
  
  
  
  
  
  
  
  
Dated:April 30, 2024  
  
endodontic status scale: Retrospective cone-beam computed tomography study. Aust Endod 
J. 2022;48(3):431-43.  
3. Al-Manei KK. Radiographic Quality of Single vs. Multiple-Visit Root Canal Treatment  
Performed by Dental Students: A Case Control Study. Iran Endod J. 2018;13(2):149-54.  
  
4. Dioguardi M, Gioia GD, Illuzzi G, Laneve E, Cocco A, Troiano G. Endodontic irrigants: 
Different methods to improve efficacy and related problems. Eur J Dent. 
2018;12(3):45966  
5. Susila A, Minu J. Activated Irrigation vs. Conventional non-activated Irrigation in 
Endodontics - A Systematic Review. Eur Endod J. 2019;4(3):96-110.  
6. Tonini R, Salvadori M, Audino E, Sauro S, Garo ML, Salgarello S. Irrigating Solutions 
and Activation Methods Used in Clinical Endodontics: A Systematic Review. Front Oral 
Health. 2022;3:e838043.  
7. Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on 
postoperative pain in mandibular molars with nonvital pulps:a randomized clinical trial.  
Int Endod J. 2017;50(6):522–30.  

Comparison of Quality of Obturation and Lateral Canal Fill (by 
Sealer)  
: Ultrasonic Activated versus Non-Ultrasonic Conventional 
Irrigation Techniques in Root Canal Treatment: A Randomized  
  
8. Kim SY, Jang YE, Kim BS, Pang EK, Shim K, Jin HR, et al. Effects of Ultrasonic 
Activation on Root Canal Filling Quality of Single-Cone Obturation with Calcium 
Silicate-Based Sealer. Materials (Basel). 2021;14(5):e1292.  
9. Al-Anesi MS, AlKhawlani MM, Alkheraif AA, Al-Basmi AA, Alhajj MN. An audit of 
root canal filling quality performed by undergraduate pre-clinical dental students, Yemen. 
BMC Med Educ. 2019;19(1):350  
  

Comparison of Quality of Obturation and Lateral Canal Fill (by  
Sealer)  
-Ultrasonic Conventional  
: A Randomized  
: Ultrasonic Activated versus Non Irrigation Techniques in Root 
Canal Treatment Controlled Trial  
 
  
  
  
  
  
  
  
  
  
Dated:April 30, 2024  
10. Gulabivala K, Ng YL. Factors that affect the outcomes of root canal treatment and 
retreatment—A reframing of the principles. Int Endod J. 2023;56:82-115.  
11. Zhang P, Yuan K, Jin Q, Zhao F, Huang Z. Presence of voids after three obturation 
techniques in band shaped isthmuses: a micro computed tomography study. BMC Oral 
Health. 2021;21(1):227-30.  
12. Chen S, Liu J, Dong G, Peng B, Yang P, Chen Z, et al. Comparison between ultrasonic 
irrigation and syringe irrigation in clinical and laboratory studies. J Oral Sci.  
2016;58(3):373-8.  
  
13. Souza CC, Bueno CE, Kato AS, Limoeiro AG, Fontana CE, Pelegrine RA. Efficacy of 
passive ultrasonic irrigation, continuous ultrasonic irrigation versus irrigation with 
reciprocating activation device in penetration into main and simulated lateral canals. J 
Conserv Dent. 2019;22(2):155-9.  
14. Verma A, Yadav RK, Tikku AP, Chandra A, Verma P, Bharti R, et al. A randomized 
controlled trial of endodontic treatment using ultrasonic irrigation and laser activated 
irrigation to evaluate healing in chronic apical periodontitis. J Clin Exp Dent. 
202;12(9):e821-e9  
  
  

 
COMPARISION OF QUALITY OF OBTURATION AND 
LATERAL CANAL FILL (BY SEALER) : ULTRASONIC 
ACTIVATED VERSUS NON-ULTRASONIC CONVENTIONAL 
IRRIGATION TECHNIQUES IN ROOT CANAL 
TREATMENT:-  A Randomized Controlled Trial  
 
  
  
  
  
  
  
  
  
Dated:April 30, 2024  
  
Data Collection Proforma  
Participant Information:  
Participant ID: __________________  
Age [years]: ___________  
Gender: [male / female] _______________  
Residenc [Rural / Urban]: _________________  
Socioeconomic status [Low / Moderate / High ]: ________________  
• 
Low = <50K PKR monthly Household income  
• 
Moderate = 50K to 150K PKR monthly household income  
• 
High = > 150K PKR monthly Household income    
Type of Tooth: [Mandibular 1st Molar/ 2nd Molar] ________________  
Side of the Tooth: [Right / Left] _________________  
Group Allocation:  
  
• 
Non-Ultrasonic Conventional Irrigation  
  
• 
Ultrasonic Activated Irrigation.  
  

 
 COMPARISION OF QUALITY OF OBTURATION AND 
LATERAL CANAL FILL (BY SEALER) : ULTRASONIC 
ACTIVATED VERSUS NON-ULTRASONIC CONVENTIONAL 
IRRIGATION TECHNIQUES IN ROOT CANAL 
TREATMENT:-  A Randomized Controlled Trial  
 
  
  
  
  
  
  
  
  
Dated:April 30, 2024  
  
  
Radiographic evaluation of obturation:  
Scoring  
- Length Score (0/1). __________  
- Density Score (0/1). __________  
- Taper Score (0/1).____________  
- Overall Obturation Quality Score (Sum of individual scores). ______________  
Radiographic evaluation of Lateral canal Fill :  
Lateral canal filling (0/1).____________  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Signature of Researcher  
  
  
 

 
COMPARISION OF QUALITY OF OBTURATION AND 
LATERAL CANAL FILL (BY SEALER) : ULTRASONIC 
ACTIVATED VERSUS NON-ULTRASONIC CONVENTIONAL 
IRRIGATION TECHNIQUES IN ROOT CANAL TREATMENT:-  
A Randomized Controlled Trial  
 
  
  
  
  
  
  
  
  
  
Dated:April 30, 2024  
  
                                       Inform consent form 
 
COMPARISION OF QUALITY OF OBTURATION AND 
LATERAL CANAL FILL (BY SEALER) : ULTRASONIC 
ACTIVATED VERSUS NON-ULTRASONIC CONVENTIONAL 
IRRIGATION TECHNIQUES IN ROOT CANAL TREATMENT:-  
A Randomized Controlled Trial  
 
                                                                                                                           Date: 30/04/2024 
Patient Name:   
  
Father/ Husband Name:   
 
I hereby, authorize concern doctor to include me in this study. The doctor has explained to me the 
procedure of collection of data in detail and I fully understand that being part of this study sample 
does not make me prone to any complications/ hazards. I have no binding or compulsion to be 
part of this study and I have freedom to refuse from being part of this sample. 
I have read this form and I am satisfied. 
Name and signature of patient:        ___________