Efficacy of Pediatric Rotary File System Versus Hand Instrumentation for Root Canal Preparation in Primary Teeth

NCT06152354 | Completed

• 1 other identifier: 124/2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The teeth were randomly allocated in two equal groups : Control group (A):- included 20 mandibular primary molars in which pulpectomy were performed by hand instrumentation system using K- File from size 15 to size 35. Experimental Group (B):- included 20 mandibular primary molars in which pulpectomy were performed by rotary system using Kedo-SG rotary file system according to manufacturer's instructions Methods of Evaluation Stage I :- During and after canal preparation:- The following parameters were evaluated for all cases in both groups:- A- The instrumentation and canal filling time were recorded for both groups using stopwatch. B- Radiographic assessment for filling were done immediately postoperative to record :-

1. 1.Distance between the apex to filling level of the mesial and distal roots .
2. 2.Obturation form

Conditions

Pulpitis

Outcome Measures

Primary Outcomes (7)

• Spontaneous Pain

  A scale from 1 to 10 where 1 is mild pain and 10 Worst pain

  baseline (immediately after procedure), after 7 days, after 1 month, 3 months, 6 months and 12 months from baseline

• Sensitivity to percussion

  Presence (1) or Absence (0)

  baseline (immediately after procedure), after 7 days, after 1 month, 3 months, 6 months and 12 months from baseline

• Tooth mobility

  Presence (1) or absence (0)

  baseline (immediately after procedure), after 6 months and 12 months from baseline

• Changes in mucobuccal folds (swelling, abscess or fistula)

  Presence (1) or Absence (0)

  baseline (immediately after procedure), after 7 days, after 1 month, 3 months, 6 months and 12 months from baseline

• Radiographic examination " internal or external root resorption"

  Presence (1) or absence (0)

  baseline (immediately after procedure), after 6 months and 12 months from baseline

• Radiographic examination " furcation radiolucency"

  Presence (1) or absence (0)

  baseline (immediately after procedure), after 6 months and 12 months from baseline

• Radiographic evaluation " widening of apical periodontal membrane space "

  Presence (1) or absence (0)

  baseline (immediately after procedure), after 6 months and 12 months from baseline

Secondary Outcomes (2)

• The instrumentation and canal filling time

  immediately postoperative

• Radiographic assessment

  immediately postoperative

Study Arms (2)

Control group

ACTIVE COMPARATOR

20 mandibular primary molars in which pulpectomy were performed by hand instrumentation system using K- File from size 15 to size 35.

Device: Manual files

Experimental group

EXPERIMENTAL

20 mandibular primary molars in which pulpectomy were performed by rotary system using Kedo-SG rotary file system according to manufacturer's instructions .

Device: rotary system

Interventions

rotary system DEVICE

crown down technique using Kedo-SG file rotary system using endodontic motor

Also known as: rotary files

Experimental group

Manual files DEVICE

instrumentation were done by step back technique using K- file (Mani ) from size 15 to size 35 in quarter pull turn motion apically

Also known as: hand instrumentation

Control group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• mandibular primary molars with deep caries indicated for pulpectomy
• Restorable lower primary molars.
• History of spontaneous pain or pain that is not relieved by analgesics.
• Pain with percussion
• Excessive bleeding from the root canals

You may not qualify if:

• Allergy to any medications used .
• Acute or chronic abscess \& fistula.
• Inter-radicular or periapical bone destruction (radiolucency) as revealed in the preoperative periapical radiograph .
• Mobility grade III.
• Internal root resorption.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

faculty of dentistry Suez canal university

Ismailia, +202064, Egypt

Location

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 30, 2023
• Study Start: October 2, 2022
• Primary Completion: October 2, 2023
• Study Completion: October 18, 2023
• Last Updated: November 30, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)