Clincosm LogoSign in Get a demo

Single Rotary File Pulpectomy in Primary Molars

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06146686
Collaborator
(none)
48
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Fanta AF blue rotary files 20 taper 4
  • Device: Fanta AF baby rotary files 20 , 25 , 30 taper 4
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The blinding of the operator is not possible due to the nature of the technique used. Trial participants, outcome assessors and statistician will be blinded
Primary Purpose:
Treatment
Official Title:
Clinical Effectiveness of Single Rotary File Versus Multiple Rotary Files in Pulpectomy of Primary Molars : A Randomized Clinical Trial
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group I ( pulpectomy using single rotary file )

After opening the access cavity, a single rotary file (20 taper 4) will be adjusted on the desirable working length depending on a radiograph (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at the rotational speed 300 rpm with torque set at the lowest level, irrigation with saline

Device: Fanta AF blue rotary files 20 taper 4
single rotary file Fanta AF blue rotary files 20 taper 4
Active Comparator: Group II ( pulpectomy using multiple rotary files system )

After opening the access cavity, multiple rotary files system (Fanta AF baby rotary files 20 taper 4, 25 taper 4, 30 taper 4) will be adjusted on the desirable working length depending on a radiograph (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at rotational speed 300 rpm with torque set at the lowest level, irrigation with saline

Device: Fanta AF baby rotary files 20 , 25 , 30 taper 4
multiple rotary files system Fanta AF baby rotary files 20 , 25 , 30 taper 4

Outcome Measures

Primary Outcome Measures

  1. instrumentation time [during the operation]

    instrumentation time of pulpectomy using single rotary file by stopwatch

Secondary Outcome Measures

  1. 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 )

  2. 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 : 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 9 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mennat-Allah Eid Ahmed Elsayed, doctor , internal resident, Cairo University
ClinicalTrials.gov Identifier:
NCT06146686
Other Study ID Numbers:
  • single rotary file pulpectomy
First Posted:
Nov 27, 2023
Last Update Posted:
Nov 27, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mennat-Allah Eid Ahmed Elsayed, doctor , internal resident, Cairo University
single rotary file pulpectomy , primary molars
Additional relevant MeSH terms:
Pulpitis

Study Results

No Results Posted as of Nov 27, 2023