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

NCT07025525 | Not Yet Recruiting

• 1 other identifier: dentistry Cairo university
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulpectomy Agents

Keywords

Primary molars; Irrigation activation within the canal

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Furcation or periapical pathology

  6 months

• External or internal root resorption

  6 months

Study Arms (4)

Intervention group 1

EXPERIMENTAL

Ultrasonic activated sodium hypochlorite

Device: Ultrasonic activated sodium hypochlorite

Intervention group 2

EXPERIMENTAL

Ultrasonic activated saline

Other: Ultrasonic acivated saline

Intervention group 3

EXPERIMENTAL

Sodium hypochlorite

Other: Sodium Hypochlorite Solution

Control group 4

ACTIVE COMPARATOR

Saline

Other: Saline

Interventions

Ultrasonic activated sodium hypochlorite DEVICE

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

Intervention group 1

Ultrasonic acivated saline OTHER

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.

Intervention group 2

Sodium Hypochlorite Solution OTHER

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.

Intervention group 3

Saline OTHER

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.

Control group 4

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical Criteria:
• Children aged between 4 to 7 years' old
• Children with deep caries involving pulp in primary molars
• History of abscess, swelling or pus
• Pain on percussion
• Mobility grade 1
• Radiographic criteria:
• Root resorption due to abscess less that ⅔ of root
• Periapical RL or furcation RL
• Widening in PDL space or loss of lamina dura continuity

You may not qualify if:

• Clinical criteria: -
• Refusal of participation.
• Patient unable to attend to follow up
• Non-restorable tooth.
• Medically compromised patient.
• Uncooperative patient

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry cairo university

Cairo, Egypt

Location

Related Publications (5)

• 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.

  PMID: 28874635 BACKGROUND

• 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.

  PMID: 29178166 BACKGROUND

• 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.

  PMID: 36817024 BACKGROUND

• Ahmed, H.M.A., 2014. Pulpectomy procedures in primary molar teeth. European Journal of General Dentistry, 3(01), pp.3-10

  BACKGROUND

• 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.

  PMID: 24676582 BACKGROUND

MeSH Terms

Interventions

Sodium Hypochlorite; Sodium Chloride

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid

Central Study Contacts

Naira Essam Naira Essam resident intern

CONTACT

0201018567752; nayera.farouk@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal resident

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: June 17, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

EG (1)