Single Rotary File Pulpectomy in Primary Molars

Not Applicable

Recruiting

• Conditions: Pulpitis - Irreversible

• Registration Number: NCT06146686
• Lead Sponsor: Cairo University

Brief Summary

The aim of this study is to compare the clinical effectiveness of a single rotary file system versus a multiple rotary files system in pulpectomy of primary molars

Detailed Description

In pediatric dentistry, premature loss of necrotic primary molars has been a matter of great concern over the years.

In modern pedodontic practice, Pulpectomy is regarded as the choice modality of treatment for pulpally involved necrotic teeth.

Hand files are used for mechanical preparation of primary tooth during pulpectomy but it has been found to be time consuming and may negatively influence the child's behavior . Much attention has been directed toward making pulpectomy a less time-consuming and a more-efficient procedure.

These challenges lead to the introduction of rotary endodontics in pediatric dentistry. However, the bizarre root canal morphology and thinner root dentin limited the use of rotary endodontics in primary teeth. Various modified protocols have been introduced to overcome such barriers to prevent undesirable complications.

Up to our knowledge, no clinical trials in the literature have been done to compare the clinical and radiographic success of single rotary file systems versus multiple rotary files systems when used in pulpectomy of primary molars. Thus, the present study aims to investigate the clinical effectiveness of those two techniques

Study Timeline

• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-24
• Study First Posted: 2023-11-27
• Study Start: 2024-02-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Primary Completion: 2025-01
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Children Criteria:

  • Medically free .
  • Cooperative patient.

Molar criteria :

• Mandibular second primary molar with clinical signs or symptoms of irreversible pulpitis

Radiographic criteria:

• No evidence of internal/external pathologic root resorption.
• With or without periapical or furcal lesion .

Exclusion Criteria

• • Uncooperative children.

  • Children with systemic disease.
  • Lack of informed consent by the child patient's parent.
  • Refusal of participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
instrumentation time	during the operation	instrumentation time of pulpectomy using single rotary file by stopwatch

Secondary Outcome Measures

Name	Time	Method
obturation quality	immediately after the operation	obturation quality measuring using periapical radiographs using Coll and Sadrian criteria ( scores) the quality of the root canal filling was defined as : 1. underfilling : all the canals were filled more than 2 mm short of the apex; 2. optimal filling : one or more of the canals having the obturant ending at the radiographic apex or up to 2 mm short of the apex; 3. overfilling : any canal showing obturant outside the root
child's cooperation level	baseline and during the operation	child's cooperation level using Frenkel's behaviour rating scale using Grades ( 1- Definitely negative 2- negative 3- positive 4- definitely positive )

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Cairo, Egypt