PulpitisNCT06152354
Efficacy of Pediatric Rotary File System Versus Hand Instrumentation for Root Canal Preparation in Primary Teeth
A study testing rotary system and Manual files in people with Pulpitis, run by Suez Canal University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Pulpitis
- What is being tested?
- rotary system and Manual files
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Oct 2022to 18 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Pediatric Rotary File System Versus Hand Instrumentation for Root Canal Preparation in Primary Teeth: An In Vivo and In Vitro Study
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.
Read more
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 :-
- Distance between the apex to filling level of the mesial and distal roots .
- 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 :
- Preoperative digital periapical radiograph were taken using standardized paralleling technique using XCP device .
- Local anesthesia were administered to the patient.
- The tooth were isolated using rubber dam .
- Caries were removed by large spoon excavator.
- The cavities were cleaned by thoroughly rinsing with chlorohexidine 0.2% .
- Access cavity were done under constant water cooling and suction using high speed round bur No.330 .
- Pulp chamber were completely deroofed .
- No .10 size K file were used to determine patency of canals.
- The working length were determined by apex locator \& periapical radiograph.
- 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 \#) 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 :-
- Distance between the apex to filling level of the mesial and distal roots .
- 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.
- Conditions
- Pulpitis
- Being tested
- rotary system, Manual files
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rotary systemDevice
Also called rotary files
crown down technique using Kedo-SG file rotary system using endodontic motor
Manual filesDevice
Also called hand instrumentation
instrumentation were done by step back technique using K- file (Mani ) from size 15 to size 35 in quarter pull turn motion apically
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 . Receives: Device: rotary system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous Pain
A scale from 1 to 10 where 1 is mild pain and 10 Worst pain
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: baseline (immediately after procedure), after 6 months and 12 months from baseline
Radiographic examination " furcation radiolucency"
Presence (1) or absence (0)
Measured: 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)
Measured: baseline (immediately after procedure), after 6 months and 12 months from baseline
Secondary outcomes (2)
The instrumentation and canal filling time
recorded for both groups using stopwatch
Measured: immediately postoperative
Radiographic assessment
Distance between the apex to filling level of the mesial and distal roots . Obturation form
Measured: immediately postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start2 Oct 2022
- Primary completion2 Oct 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpitisStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152354
- Sponsor's protocol ID
- 124/2018
- Status last verified
- Oct 2022
- First submitted
- 29 Oct 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pediatric Rotary File System Versus Hand Instrumentation for Root Canal Preparation in Primary Teeth: An In Vivo and In Vitro Study
- ClinicalTrials.gov ID
- NCT06152354
- Acronym / sponsor ID
- 124/2018
- Conditions
- Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 2 Oct 2022 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :-
- Distance between the apex to filling level of the mesial and distal roots .
- 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.
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 :
- Preoperative digital periapical radiograph were taken using standardized paralleling technique using XCP device .
- Local anesthesia were administered to the patient.
- The tooth were isolated using rubber dam .
- Caries were removed by large spoon excavator.
- The cavities were cleaned by thoroughly rinsing with chlorohexidine 0.2% .
- Access cavity were done under constant water cooling and suction using high speed round bur No.330 .
- Pulp chamber were completely deroofed .
- No .10 size K file were used to determine patency of canals.
- The working length were determined by apex locator \& periapical radiograph.
- 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 \#) 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 :-
- Distance between the apex to filling level of the mesial and distal roots .
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: Manual files20 mandibular primary molars in which pulpectomy were performed by hand instrumentation system using K- File from size 15 to size 35. |
| Experimental group | Experimental | Device: rotary system20 mandibular primary molars in which pulpectomy were performed by rotary system using Kedo-SG rotary file system according to manufacturer's instructions . |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rotary systemAlso: rotary filescrown down technique using Kedo-SG file rotary system using endodontic motor | Device | Experimental group |
| Manual filesAlso: hand instrumentationinstrumentation were done by step back technique using K- file (Mani ) from size 15 to size 35 in quarter pull turn motion apically | Device | Control group |
Primary outcome
Spontaneous Pain
Time frame: baseline (immediately after procedure), after 7 days, after 1 month, 3 months, 6 months and 12 months from baseline
A scale from 1 to 10 where 1 is mild pain and 10 Worst pain
Sensitivity to percussion
Time frame: baseline (immediately after procedure), after 7 days, after 1 month, 3 months, 6 months and 12 months from baseline
Presence (1) or Absence (0)
Tooth mobility
Time frame: baseline (immediately after procedure), after 6 months and 12 months from baseline
Presence (1) or absence (0)
Changes in mucobuccal folds (swelling, abscess or fistula)
Time frame: baseline (immediately after procedure), after 7 days, after 1 month, 3 months, 6 months and 12 months from baseline
Presence (1) or Absence (0)
Radiographic examination " internal or external root resorption"
Time frame: baseline (immediately after procedure), after 6 months and 12 months from baseline
Presence (1) or absence (0)
Radiographic examination " furcation radiolucency"
Time frame: baseline (immediately after procedure), after 6 months and 12 months from baseline
Presence (1) or absence (0)
Radiographic evaluation " widening of apical periodontal membrane space "
Time frame: baseline (immediately after procedure), after 6 months and 12 months from baseline
Presence (1) or absence (0)
2 secondary outcomes
The instrumentation and canal filling time
Time frame: immediately postoperative
Radiographic assessment
Time frame: immediately postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rotary system and Manual files in people with Pulpitis, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous Pain (time frame: baseline (immediately after procedure), after 7 days, after 1 month, 3 months, 6 months and 12 months from baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.