Instrumentation TimeNCT05665803
Comparative Evaluation of Instrumentation Time Using Pediatric Rotary Versus Hand (Flare) File Systems
A study testing Pediatric rotary files and Manual flare files in people with Instrumentation Time, run by Cairo University.
Trial summary
The study will be conducted to evaluate instrumentation time, obturation quality, and child's behavior using pediatric rotary versus hand flare file systems in treatment of primary molars. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Instrumentation Time
- What is being tested?
- Pediatric rotary files and Manual flare files
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Mar 2024
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Children:
- Cooperative children.
- 4-6 years old children.
- Children who will attend follow up.
- Teeth:
- Bilateral lower second primary molars.
- Pulpally involved molars indicated for pulpectomy.
Who cannot join
- Children:
- Children with physical or emotional alteration.
- Children with systemic diseases.
- Children of parents who don't accept to participate in the study.
- Teeth:
- Teeth with more than 1/3 of root resorption.
Show all 9Show fewer
- Teeth with pathological mobility.
- Necrotic teeth with periapical or furcal lesions.
- Non restorable teeth.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Evaluation of Instrumentation Time, Obturation Quality, and Child's Behavior Using Pediatric Rotary Versus Hand (Flare) File Systems in Treatment of Primary Molars: a Split Mouth Randomized Clinical Trial
The study will be conducted to evaluate instrumentation time, obturation quality, and child's behavior using pediatric rotary versus hand flare file systems in treatment of primary molars.
Read the detailed description
Statement of the problem:
Pulpally affected primary teeth is a common problem in children due to lower mineralization, the presence of large pulp chamber with high pulp horns, and thin layers of enamel and dentin .
Manual files system is usually used for management of pulpally affected primary molars. This system has shown through the past years an acceptable clinical success rate but it also have many problems such as long visit time affecting the child behavior and causing fatigue to the dentist, difficulty in dealing with thin and curved canals due to limited flexibility of manual files causing incomplete removal of pulp tissue, and also difficulty in the determination of the actual working length due to the presence of physiologic and pathologic root resorption.
Rationale for conducting the research:
Pulp therapy in primary molars becomes compromised sometimes after delayed treatment due to dental neglect of children till caries progression to the pulp leading to severe symptoms associated with excessive pulp inflammation, root resorption, or periradicular bone resorption with a less favorable prognosis for conventional endodontic therapy. In the current era, a new perspective which is less time consuming with an acceptable success rate could be a spark of hope for the pediatric patient as well as the dentists.
Many studies were done comparing manual vs pediatric rotary files but without definitive conclusion. So further studies should be done with higher sample size to determine the superiority of one system over the other.
Benefits for the practitioner:
- Providing new and alternative treatment options.
- Shorter instrumentation time.
- Less fatigue.
- Better preparation of the canal.
Benefits for the patient:
- A faster and easier process leading to a more efficient dental procedure which could develop better outcomes in terms of success.
- Improvement in patient as well as parent satisfaction.
Benefits for community:
- Using alternative technique that can be faster, with a better success rate.
- To boost overall oral health.
- Conditions
- Instrumentation Time
- Being tested
- Pediatric rotary files, Manual flare files
- Keywords
- Rotary files, Manual flare files
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric rotary filesProcedure or surgery
Mechanical preparation of primary tooth canals with pediatric rotary files
Manual flare filesProcedure or surgery
Mechanical preparation of primary tooth canals with manual flare files
| Study group | Role | What they receive |
|---|---|---|
| Pediatric rotary files | Experimental | Biomechanical preparation will be done using pediatric rotary file system (Kedo-SG blue file system). D1 and E1 files will be used at 300 rpm and 2.4 N/cm torque. Receives: Procedure: Pediatric rotary files |
| Manual flare files | Active comparator | Biomechanical preparation will be done using manual flare files (Mani) No. 15-35. Receives: Procedure: Manual flare files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instrumentation time
Continuous outcome measured by digital stopwatch in minutes
Measured: during procedure
Secondary outcomes (8)
Child's behaviour
Using modified frankel scale from 1-5, where scale 1 has the worse behavior and scale 5 has the best behavior
Measured: during procedure
Postoperative pain
Binary outcome reported by telephone call to the parents
Measured: 7 days
Tenderness to percussion
Binary outcome measured by percussion test using back of the dental mirror
Measured: 1 year
Pain on biting
Binary outcome reported by the patient at biting
Measured: 1 year
Swelling/ fistula / sinus tract
Binary outcome measured with visual examination of the patient
Measured: 1 year
Mobility
Binary outcome measured by mobility test using back of the two dental mirrors
Measured: 1 year
Internal or external root resorption
Binary outcome using digital radiograph
Measured: 1 year
Furcation involvement or periapical radiolucency
Binary outcome using digital radiograph
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Instrumentation TimeStudies 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
- Model description
- Split mouth RCT
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Wafik Ismael Mohamed, Cairo University
- Investigators
- Manal A Elsayed, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665803
- Sponsor's protocol ID
- Pediatric rotary files
- Status last verified
- Dec 2022
- First submitted
- 6 Dec 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be provided upon request
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Instrumentation Time, Obturation Quality, and Child's Behavior Using Pediatric Rotary Versus Hand (Flare) File Systems in Treatment of Primary Molars: a Split Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05665803
- Acronym / sponsor ID
- Pediatric rotary files
- Conditions
- Instrumentation Time
- Keywords
- Rotary files, Manual flare files
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 27 Dec 2022 (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 study will be conducted to evaluate instrumentation time, obturation quality, and child's behavior using pediatric rotary versus hand flare file systems in treatment of primary molars.
Detailed description
Statement of the problem:
Pulpally affected primary teeth is a common problem in children due to lower mineralization, the presence of large pulp chamber with high pulp horns, and thin layers of enamel and dentin .
Manual files system is usually used for management of pulpally affected primary molars. This system has shown through the past years an acceptable clinical success rate but it also have many problems such as long visit time affecting the child behavior and causing fatigue to the dentist, difficulty in dealing with thin and curved canals due to limited flexibility of manual files causing incomplete removal of pulp tissue, and also difficulty in the determination of the actual working length due to the presence of physiologic and pathologic root resorption.
Rationale for conducting the research:
Pulp therapy in primary molars becomes compromised sometimes after delayed treatment due to dental neglect of children till caries progression to the pulp leading to severe symptoms associated with excessive pulp inflammation, root resorption, or periradicular bone resorption with a less favorable prognosis for conventional endodontic therapy. In the current era, a new perspective which is less time consuming with an acceptable success rate could be a spark of hope for the pediatric patient as well as the dentists.
Many studies were done comparing manual vs pediatric rotary files but without definitive conclusion. So further studies should be done with higher sample size to determine the superiority of one system over the other.
Benefits for the practitioner:
- Providing new and alternative treatment options.
- Shorter instrumentation time.
- Less fatigue.
- Better preparation of the canal.
Benefits for the patient:
- A faster and easier process leading to a more efficient dental procedure which could develop better outcomes in terms of success.
- Improvement in patient as well as parent satisfaction.
Benefits for community:
- Using alternative technique that can be faster, with a better success rate.
- To boost overall oral health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth RCT
| Arm | Type | Receives |
|---|---|---|
| Pediatric rotary files | Experimental | Procedure: Pediatric rotary filesBiomechanical preparation will be done using pediatric rotary file system (Kedo-SG blue file system). D1 and E1 files will be used at 300 rpm and 2.4 N/cm torque. |
| Manual flare files | Active comparator | Procedure: Manual flare filesBiomechanical preparation will be done using manual flare files (Mani) No. 15-35. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Cooperative children.
- 4-6 years old children.
- Children who will attend follow up.
- Bilateral lower second primary molars.
- Pulpally involved molars indicated for pulpectomy.
Key exclusion criteria (9 listed)
- Children with physical or emotional alteration.
- Children with systemic diseases.
- Children of parents who don't accept to participate in the study.
- Teeth with more than 1/3 of root resorption.
- Teeth with pathological mobility.
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 |
|---|---|---|
| Pediatric rotary filesMechanical preparation of primary tooth canals with pediatric rotary files | Procedure or surgery | Pediatric rotary files |
| Manual flare filesMechanical preparation of primary tooth canals with manual flare files | Procedure or surgery | Manual flare files |
Primary outcome
Instrumentation time
Time frame: during procedure
Continuous outcome measured by digital stopwatch in minutes
8 secondary outcomes
Child's behaviour
Time frame: during procedure
Postoperative pain
Time frame: 7 days
Tenderness to percussion
Time frame: 1 year
Pain on biting
Time frame: 1 year
Swelling/ fistula / sinus tract
Time frame: 1 year
Mobility
Time frame: 1 year
Internal or external root resorption
Time frame: 1 year
Furcation involvement or periapical radiolucency
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Individual participant dataSharing planned: No. Data may be provided upon request
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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.
Manal A Elsayed, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric rotary files and Manual flare files in people with Instrumentation Time, run by Cairo University.
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 7 inclusion and 9 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 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmed W Ismael, Master (+21114036028, ahmed.ismael@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 procedure). 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 27 Dec 2022.