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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Pulpectomy Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Intervention group 1

Ultrasonic activated sodium hypochlorite

Group Type EXPERIMENTAL

Ultrasonic activated sodium hypochlorite

Intervention Type 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 2

Ultrasonic activated saline

Group Type EXPERIMENTAL

Ultrasonic acivated saline

Intervention Type 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 3

Sodium hypochlorite

Group Type EXPERIMENTAL

Sodium Hypochlorite Solution

Intervention Type 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.

Control group 4

Saline

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type 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.

Interventions

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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

Intervention Type DEVICE

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No