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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Pulpectomy Agents

Treatments: Device: Ultrasonic activated sodium hypochlorite; Other: Sodium Hypochlorite Solution; Other: Saline; Other: Ultrasonic acivated saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07025525

dentistry Cairo university

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 4 patient groups

Intervention group 1

Experimental group

Description:

Ultrasonic activated sodium hypochlorite

Treatment:

Device: Ultrasonic activated sodium hypochlorite

Intervention group 2

Experimental group

Description:

Ultrasonic activated saline

Treatment:

Other: Ultrasonic acivated saline

Intervention group 3

Experimental group

Description:

Sodium hypochlorite

Treatment:

Other: Sodium Hypochlorite Solution

Control group 4

Active Comparator group

Description:

Saline

Treatment:

Other: Saline