Clinical trial NCT06146686: Single Rotary File Pulpectomy in Primary Molars
Official title: Clinical Effectiveness of Single Rotary File Versus Multiple Rotary Files in Pulpectomy of Primary Molars : A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulpitis - Irreversible
Keywords: single rotary file pulpectomy , primary molars
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 48
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: instrumentation time
timeFrame: during the operation
Secondary outcomes:
measure: child's cooperation level
timeFrame: baseline and during the operation
measure: obturation quality
timeFrame: immediately after the operation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
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.
citation: 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.