Single Rotary File Pulpectomy in Primary Molars

Pulpitis - Irreversible Clinical Trial

Official title:

Clinical Effectiveness of Single Rotary File Versus Multiple Rotary Files in Pulpectomy of Primary Molars : A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06146686
• Other study ID #: single rotary file pulpectomy
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: Mennat-Allah Eid Ahmed, MAster
• Phone: 0201119309905
• Email: mennaallah-eid[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: April 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

Device:
• Fanta AF blue rotary files 20 taper 4
single rotary file Fanta AF blue rotary files 20 taper 4
• Fanta AF baby rotary files 20 , 25 , 30 taper 4
multiple rotary files system Fanta AF baby rotary files 20 , 25 , 30 taper 4

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Kalita S, Agarwal N, Jabin Z, Anand A. Comparative Evaluation of Cleaning Capacity and Efficiency of Kedo-S Pediatric Rotary Files, Rotary ProTaper, and Hand K Files in Primary Molar Pulpectomy. Int J Clin Pediatr Dent. 2021 May-Jun;14(3):383-387. doi: 10.5005/jp-journals-10005-1958. — View Citation

Kohli A, Chhabra J, Sharma K, Katyayan R, Bhatnagar P, Sharma A. Comparative Evaluation of Instrumentation Time and Quality of Obturation amongst Pediatric Rotary Endodontic System: An In Vivo Study. Int J Clin Pediatr Dent. 2023 Mar-Apr;16(2):338-343. doi: 10.5005/jp-journals-10005-2573. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	instrumentation time	instrumentation time of pulpectomy using single rotary file by stopwatch	during the operation
Secondary	child's cooperation level	child's cooperation level using Frenkel's behaviour rating scale using Grades ( 1- Definitely negative 2- negative 3- positive 4- definitely positive )	baseline and during the operation
Secondary	obturation quality	obturation quality measuring using periapical radiographs using Coll and Sadrian criteria ( scores) the quality of the root canal filling was defined as : underfilling : all the canals were filled more than 2 mm short of the apex; 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; overfilling : any canal showing obturant outside the root	immediately after the operation