Clinical and Radiographic Evaluation of Ultrasonic Activated Irrigation Versus Non Activated Irrigation in Pulpectomy of Necrotic Primary Molars : A Randomized Clinical Trial

This is a Clinical and Radiographic Evaluation of Canal Irrigation Using Ultrasonically Activated vs. Non-Activated Irrigants in Pulpectomy of Necrotic Primary Molars: A Randomized Clinical Trial" This study aims to compare the effectiveness of using ultrasonically activated irrigant versus non-activated irrigant in terms of clinical and radiographic success rates in the pulpectomy of necrotic primary molars, through a randomized clinical trial.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulpectomy Agents
• Intervention / Treatment: Device: Ultrasonic activated sodium hypochlorite; Other: Ultrasonic acivated saline; Other: Sodium Hypochlorite Solution; Other: Saline

Detailed Description

Primary teeth are considered of great importance to children allowing their normal, healthy development and growth while preserving function, eating, speech and normal development of occlusion while preserving the space for permanent dentition and guide their eruption.

Pulpectomy of primary molar teeth is considered as reasonable treatment approach to ensure either normal shedding or long term survival of 1ry teeth as fully functional component in dental arch.

Treatment of necrotic primary teeth is complex due to anatomical and physiological characteristics and high no. of bacterial species present in endodontic infection.

Treatment success depend on the elimination of root canal infection which can be done mechanically and chemically to ensure the complete removal of bacterial canal infection.

Irrigation is a key part of successful root canal treatment. It has several important functions, the most important one that it has a washing effect and an antimicrobial/antibiofilm effect. Irrigation is also the only way to impact those areas of the root canal wall not touched by mechanical instrumentation.

Ultrasonic activation cause irrigant streaming and cavitation phenomena resulting in significantly improved debridement of canal spaces, disruption of biofilm and improved penetration of irrigant into dentinal tubules and reduces bacterial level improving prognosis and ability to seal.

This study has been conducted by only few researchers, and there is limited evidence supporting the effect of ultrasonic activation on irrigation.

So this study is conducted to compare the effect of ultrasonic activation of irrigation on success of pulpectomy versus that of non-activated irrigation

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naira Essam Naira Essam resident intern; Phone Number: 0201018567752; Email: nayera.farouk@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry Cairo University
    • Contact: Rasha Mohamed Rasha Hatem Associate Professor; Phone Number: 02 0100 1670222; Email: rasha.hatem@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

-

Clinical Criteria:

1. Children aged between 4 to 7 years' old
2. Children with deep caries involving pulp in primary molars
3. History of abscess, swelling or pus
4. Pain on percussion
5. Mobility grade 1

Radiographic criteria:

1. Root resorption due to abscess less that ⅔ of root
2. Periapical RL or furcation RL
3. Widening in PDL space or loss of lamina dura continuity

Exclusion Criteria:

• Clinical criteria: -

  1. Refusal of participation.
  2. Patient unable to attend to follow up
  3. Non-restorable tooth.
  4. Medically compromised patient.
  5. Uncooperative patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group 1; Ultrasonic activated sodium hypochlorite	Device: Ultrasonic activated sodium hypochlorite; Using ultrasonic-activated sodium hypochlorite in the canals of primary molars can significantly enhance root canal disinfection by improving the irrigant's penetration and effectiveness. Primary molars often have complex and irregular canal anatomies, which can limit the reach of traditional irrigation methods. Ultrasonic activation creates acoustic streaming and cavitation effects, allowing sodium hypochlorite to better dissolve organic tissue and disrupt bacterial biofilms, especially in hard-to-reach areas. This leads to more thorough cleaning, reduced microbial load, and potentially better clinical outcomes in pediatric endodontics
Experimental: Intervention group 2; Ultrasonic activated saline	Other: Ultrasonic acivated saline; using ultrasonic-activated saline within the canals of primary teeth lies in its ability to enhance mechanical debridement and improve irrigation effectiveness without the risks associated with stronger chemical agents. Although saline lacks inherent antimicrobial properties, ultrasonic activation generates acoustic streaming and cavitation, which help dislodge debris, disrupt biofilms, and clean intricate canal anatomy more efficiently than passive irrigation. This makes it a safer alternative in pediatric patients, minimizing the risk of cytotoxic effects or damage to developing permanent tooth buds while still improving cleaning outcomes.
Experimental: Intervention group 3; Sodium hypochlorite	Other: Sodium Hypochlorite Solution; using sodium hypochlorite (NaOCl) within the canals of primary molars is its excellent antimicrobial and tissue-dissolving properties, which are essential for effective root canal disinfection. Primary molars often have complex and irregular canal systems that harbor bacteria and necrotic tissue. Sodium hypochlorite not only helps eliminate a broad spectrum of microorganisms but also dissolves organic debris, improving canal cleanliness and reducing the risk of post-treatment infection. When used in appropriate concentrations, it can significantly enhance the success of pulpectomy procedures in pediatric patients while maintaining safety.
Active Comparator: Control group 4; Saline	Other: Saline; Saline is commonly used as an irrigant in the root canal treatment of primary molars due to its excellent biocompatibility and safety profile. It is a non-toxic, isotonic solution that poses no risk to the surrounding periapical tissues, which is particularly important in primary teeth where root resorption and open apices are common. This minimizes the chance of damaging the underlying permanent tooth germ, a critical consideration in pediatric dentistry. Saline is also safe if accidentally extruded beyond the apex or ingested, making it a suitable choice for young children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain	Post operative pain assessments will be clinically , binary yes or no oral from patients word	6 months
Soft tissue pathology	This outcome will be measured clinically , binary yes or no by visual inspection	6 months
Pain on percussion	Will measured clinically , binary yes or no using back of mirror for percussion assessment	6 months
Pathological mobility	Will be assessed clinically , binary by yes or no using back of mirror and finger of one hand to check mobility	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Furcation or periapical pathology	Will be measured clinically by periapical radiograph binary yes or no the presence of Radiolucency	6 months
External or internal root resorption	Will be assessed by radiograph binary yes or no checking radiolucency	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Singh R, Barua P, Kumar M, Safaya R, Monajemi H, Monajemi H. Effect of Ultrasonic Instrumentation in Treatment of Primary Molars. J Contemp Dent Pract. 2017 Sep 1;18(9):750-753. doi: 10.5005/jp-journals-10024-2120.
• Virdee SS, Seymour DW, Farnell D, Bhamra G, Bhakta S. Efficacy of irrigant activation techniques in removing intracanal smear layer and debris from mature permanent teeth: a systematic review and meta-analysis. Int Endod J. 2018 Jun;51(6):605-621. doi: 10.1111/iej.12877. Epub 2017 Dec 22.
• Kumar RS, Ankola AV, Sankeshwari RM, Hebbal M, Hampiholi V, Kumar S L, Deshpande AP, Choudhury AR, Pai Khot AJ. Effectiveness of various irrigant activation techniques on the penetration of sodium hypochlorite into lateral canals of mature permanent teeth: A systematic review and meta-analysis. Saudi Dent J. 2023 Jan;35(1):1-23. doi: 10.1016/j.sdentj.2022.12.004. Epub 2022 Dec 16.
• Ahmed, H.M.A., 2014. Pulpectomy procedures in primary molar teeth. European Journal of General Dentistry, 3(01), pp.3-10
• Fabris AS, Nakano V, Avila-Campos MJ. Bacteriological analysis of necrotic pulp and fistulae in primary teeth. J Appl Oral Sci. 2014 Apr;22(2):118-24. doi: 10.1590/1678-775720130358.

Helpful Links

• The paper title

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: June 7, 2025
• First Submitted That Met QC Criteria: June 13, 2025
• First Posted (Actual): June 17, 2025

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Primary molars; Irrigation activation within the canal
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Anti-Infective Agents; Disinfectants; Sodium Hypochlorite; Eusol
• Other Study ID Numbers: dentistry Cairo university

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No