CClinicalTrials.gg
CompletedNCT06152354Updated Nov 30, 2023

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

An interventional study of rotary system and Manual files in Pulpitis, sponsored by Suez Canal University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2023-11-30.

Sponsored by Suez Canal University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Oct 2022, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
4 Years to 6 Years
Sex
All
01

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

Stage II : Follow up :

The follow up were carried out by clinical and radiographic evaluation for all cases in both groups:-

The clinical evaluation were carried out at (0 base line = after 7 days ) then after 1 , 3 , 6 and 12 months .

Radiographic evaluation were performed immediately postoperative as (0 baseline ) after cementation of stainless steel crowns for assessment of filling quality. Radiographs will be used for comparison for consequent radiographs . Follow ups were performed after 6 and 12 months.

Read the detailed description

The planned study is a randomized clinical controlled trial including apparently healthy children who were selected from the patients attending the Out- Patient Clinic , Pediatric Dentistry Department, Faculty of Dentistry, Suez Canal University. Informed written consent were obtained from parents or guardians of the children after full explanation of clinical procedures and detailed treatment plan.

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

Clinical procedures :

  1. Preoperative digital periapical radiograph were taken using standardized paralleling technique using XCP device .
  2. Local anesthesia were administered to the patient.
  3. The tooth were isolated using rubber dam .
  4. Caries were removed by large spoon excavator.
  5. The cavities were cleaned by thoroughly rinsing with chlorohexidine 0.2% .
  6. Access cavity were done under constant water cooling and suction using high speed round bur No.330 .
  7. Pulp chamber were completely deroofed .
  8. No .10 size K file were used to determine patency of canals.
  9. The working length were determined by apex locator \& periapical radiograph.
  10. Depending on the group allocation , the canal instrumentation were done by step back technique using K- file (Mani ) from size 15 to size 35 in quarter pull turn motion apically or by crown down technique using Kedo-SG file rotary system using endodontic motor.

11 - After each instrumentation , the canal were irrigated by 1% sodium hypochlorite .

12- The canal were dried with paper points( #30 \&#35) 13- Then canal were filled with creamy mix of Zinc oxide \& Egenol. 14-Zinc phosphate cement were placed over Zinc oxide \& Egenol then finally restored by Stainless steel crown .

15-Postoperative digital periapical radiographs were taken using standardized paralleling technique using XCP device .

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

Stage II : Follow up :

The follow up were carried out by clinical and radiographic evaluation for all cases in both groups:-

The clinical evaluation were carried out at (0 base line = after 7 days ) then after 1 , 3 , 6 and 12 months .

The following clinical criteria were evaluated: -

  • Spontaneous pain as described by Oginin and Undoye ( 29)
  • Sensitivity to percussion presence or absence.
  • Tooth mobility presence or absence.
  • Examination of any changes of the mucobuccal folds (presence or absence of swelling, sinus, draining fistula or abscess).

If the tooth exhibits any of above clinical features, the pulpectomy was considered a failure (F); otherwise, it was regarded as clinical success (S).

Radiographic evaluation were performed immediately postoperative as (0 baseline ) after cementation of stainless steel crowns for assessment of filling quality. Radiographs will be used for comparison for consequent radiographs . Follow ups were performed after 6 and 12 months.

The following radiographic criteria were evaluated :-

  • Presence or absence of widening of apical periodontal membrane space .
  • Presence or absence of furcation radioluency .
  • Presence or absence of internal or external root resorption .

All patients were examined using standardized intra oral paralleling periapical direct digital radiographs using the rinn (XCP) periapical film holder and a long cone. Radiometric and radiodensitometric analysis of the radiographs were carried out using the software of Digora (2.5) system.

Dates of follow up visits were written on the patient 's recall card , parents were asked to call if any symptoms of pain or infection occurred at any time before recall visit .If there is any complications during follow up periods, different techniques of treatment were done according to the case.

02

Conditions studied

  • Pulpitis

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03

In context

Pulpitis

302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.

This study's enrollment of 40 is below the median of 62 across 275 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

Suez Canal University is the lead sponsor of 157 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Allergy to any medications used .
  • Inability to come in recall visits . mandibular primary molars with exclusion criteria as follows:-
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Control group

    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
    Experimental group

    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

  • Devicerotary system

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

    Also known as: rotary files

  • DeviceManual files

    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

06

What researchers measure

Primary outcomes

  1. Spontaneous Pain

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

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

  2. Sensitivity to percussion

    Presence (1) or Absence (0)

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

  3. Tooth mobility

    Presence (1) or absence (0)

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

  4. Changes in mucobuccal folds (swelling, abscess or fistula)

    Presence (1) or Absence (0)

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

  5. Radiographic examination " internal or external root resorption"

    Presence (1) or absence (0)

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

  6. Radiographic examination " furcation radiolucency"

    Presence (1) or absence (0)

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

  7. Radiographic evaluation " widening of apical periodontal membrane space "

    Presence (1) or absence (0)

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

Secondary outcomes

  1. The instrumentation and canal filling time

    recorded for both groups using stopwatch

    Time frame: immediately postoperative

  2. Radiographic assessment

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

    Time frame: immediately postoperative

07

Study locations

1 site
  • faculty of dentistry Suez canal university
    Ismailia, +202064, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06152354
Lead sponsor
Suez Canal University
Responsible party
Sponsor
First posted
Nov 30, 2023
Start date
Oct 2, 2022
Primary completion
Oct 2, 2023
Completion
Oct 18, 2023
Last update
Nov 30, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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