Obturation Quality in Primary Molars

NCT06157021 | Completed

• 1 other identifier: 1-11-23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Forty cases of necrotic primary molars in children aged 4-8 years were selected to compare the effect of manual versus rotary pulpectomy regarding parental acceptance and obturation quality.

Conditions

Necrotic Primary Molars

Keywords

Rotary instrumentation; pulpectomy; primary molars; obturation quality

Outcome Measures

Primary Outcomes (1)

• parental acceptance

  done by the participating parents who ranked their acceptance to pulpectomy procedures on a five-point Likert scale, as follows: 1, strongly acceptable; 2, acceptable; 3, neutral; 4, unacceptable; and 5, strongly unacceptable. (Scores from 1-3 means better outcome)

  Immediately after the intervention

Secondary Outcomes (1)

• obturation quality

  Immediately after the intervention and after 6 months

Study Arms (2)

Rotary pulpectomy

EXPERIMENTAL

Rotary pulpectomy using rotary files (Fanta AF baby\* rotary files and Endo Radar\* rotary device

Procedure: Rotary pulpectomy

Manual pulpectomy

ACTIVE COMPARATOR

Manual pulpectomy using manual H files, Mani\*)

Procedure: Manual pulpectomy

Interventions

Rotary pulpectomy PROCEDURE

Pulpectomy procedures by making cleaning and shaping of root canals of necrotic primary molars using (Fanta AF baby\* rotary files and Endo Radar\* rotary device).

Also known as: (Fanta AF baby* rotary files and Endo Radar* rotary device).

Rotary pulpectomy

Manual pulpectomy PROCEDURE

Pulpectomy procedures by making cleaning and shaping of root canals of necrotic primary molars using Manual H files, Mani\*)

Also known as: Manual H files, Mani*)

Manual pulpectomy

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Medically free children.
• Age: 4-8 years
• Primary molars with necrotic pulp, abscess or fistula.
• Teeth which if lost possibility of space maintainer construction exists.
• Pre-operative radiograph showing absence of root resorption more than one third of the root.

You may not qualify if:

• Vital primary teeth.
• Teeth with inadequate tooth structure to support the rubber dam.
• Expected shedding time within one year.
• Peri-radicular involvement extending to the permanent tooth bud.
• Excessive internal\& external root resorption,
• Perforation of pulpal floor.
• Extensive tooth mobility

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo university

Cairo, 11553, Egypt

Location

Study Officials

• Rasha A Ragab, Lecturer

  Faculty of Dentistry, Cairo University, Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding to the child participants and legal guardian of each participating child, inter examiner and statistician. The operator and the child were blinded to the intervention from the beginning till finishing the procedure of caries removal and access cavity. Blinding cannot be done during root canal instrumentation because of visual differences between manual and rotary files.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Randomized controlled parallel double blinded study

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: December 5, 2023
• Study Start: November 15, 2023
• Primary Completion: June 15, 2024
• Study Completion: July 15, 2024
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)