Pulpitis - IrreversibleNCT06146686
Single Rotary File Pulpectomy in Primary Molars
A study testing Fanta AF blue rotary files 20 taper 4 and Fanta AF baby rotary files 20 , 25 , 30 taper 4 in people with Pulpitis - Irreversible, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Fanta AF blue rotary files 20 taper 4 and Fanta AF baby rotary files 20 , 25 , 30 taper 4
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to Apr 2025
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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 .
Who cannot join
- • Uncooperative children.
- Children with systemic disease.
- Lack of informed consent by the child patient's parent.
- Refusal of participation.
Trial locations and contacts
1 site in 1 country.
Reem mohamed fouad, PHD contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Cairo
Menna EA Ahmed, master, 0201119309905, mennaeid96@gmail.com
reem RW, phd
About this study
Official title: Clinical Effectiveness of Single Rotary File Versus Multiple Rotary Files in Pulpectomy of Primary Molars : A Randomized Clinical Trial
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
Read the 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
- Conditions
- Pulpitis - Irreversible
- Being tested
- Fanta AF blue rotary files 20 taper 4, Fanta AF baby rotary files 20 , 25 , 30 taper 4
- Keywords
- single rotary file pulpectomy , primary molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fanta AF blue rotary files 20 taper 4Device
single rotary file Fanta AF blue rotary files 20 taper 4
Fanta AF baby rotary files 20 , 25 , 30 taper 4Device
multiple rotary files system Fanta AF baby rotary files 20 , 25 , 30 taper 4
| Study group | Role | What they receive |
|---|---|---|
| Group I ( pulpectomy using single rotary file ) | Experimental | 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 Receives: Device: Fanta AF blue rotary files 20 taper 4 |
| Group II ( pulpectomy using multiple rotary files system ) | Active comparator | 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 Receives: Device: Fanta AF baby rotary files 20 , 25 , 30 taper 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
instrumentation time
instrumentation time of pulpectomy using single rotary file by stopwatch
Measured: during the operation
Secondary outcomes (2)
child's cooperation level
child's cooperation level using Frenkel's behaviour rating scale using Grades ( 1- Definitely negative 2- negative 3- positive 4- definitely positive )
Measured: baseline and during the operation
obturation quality
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
Measured: immediately after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start1 Feb 2024
- Primary completionJan 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat-Allah Eid Ahmed Elsayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146686
- Sponsor's protocol ID
- single rotary file pulpectomy
- Status last verified
- Apr 2024
- First submitted
- 17 Nov 2023
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37519962Kalita 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.
PubMed 34720511
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Single Rotary File Versus Multiple Rotary Files in Pulpectomy of Primary Molars : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06146686
- Acronym / sponsor ID
- single rotary file pulpectomy
- Conditions
- Pulpitis - Irreversible
- Keywords
- single rotary file pulpectomy , primary molars
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 27 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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I ( pulpectomy using single rotary file ) | Experimental | Device: Fanta AF blue rotary files 20 taper 4After 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 |
| Group II ( pulpectomy using multiple rotary files system ) | Active comparator | Device: Fanta AF baby rotary files 20 , 25 , 30 taper 4After 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 |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children Criteria:
- Mandibular second primary molar with clinical signs or symptoms of irreversible pulpitis
- No evidence of internal/external pathologic root resorption.
- With or without periapical or furcal lesion .
Key exclusion criteria (4 listed)
- • Uncooperative children.
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 |
|---|---|---|
| Fanta AF blue rotary files 20 taper 4single rotary file Fanta AF blue rotary files 20 taper 4 | Device | Group I ( pulpectomy using single rotary file ) |
| Fanta AF baby rotary files 20 , 25 , 30 taper 4multiple rotary files system Fanta AF baby rotary files 20 , 25 , 30 taper 4 | Device | Group II ( pulpectomy using multiple rotary files system ) |
Primary outcome
instrumentation time
Time frame: during the operation
instrumentation time of pulpectomy using single rotary file by stopwatch
2 secondary outcomes
child's cooperation level
Time frame: baseline and during the operation
obturation quality
Time frame: immediately after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Background: PubMed 37519962Kohli 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.
- Background: PubMed 34720511Kalita 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.
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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.
Reem mohamed fouad, PHD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fanta AF blue rotary files 20 taper 4 and Fanta AF baby rotary files 20 , 25 , 30 taper 4 in people with Pulpitis - Irreversible, run by Cairo 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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mennat-Allah Eid Ahmed, MAster (0201119309905, mennaallah-eid@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
instrumentation time (time frame: during the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06146686, which also lists 2 linked publications.
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 5 Apr 2024.