Irreversible Pulpitis (toothache)NCT06714305
Comparison of Effectiveness of Hand Versus Rotary Instrumentation in Pulpectomy of Primary Second Molar Teeth.
A study testing Group B will be assigned to rotary instrumentation. and will be assigned to rotary instrumentation. in people with Irreversible Pulpitis (toothache), run by RANA AHMAD at 1 site in Pakistan.
Trial summary
To provide an effective technique for pulpectomy in primary second molar teeth in pakistani population, local studies are required. No local studies have been done so far and limited number of international in vivo studies have been conducted previously. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Irreversible Pulpitis (toothache)
- What is being tested?
- Group B will be assigned to rotary instrumentation. and will be assigned to rotary instrumentation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 31 Jan 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of both genders having age 4-6.5 years
- Children having signs and symptoms of irreversible pulpitis in their second primary molar teeth on clinical examination as per operational definition.
Who cannot join
- Children having previously accessed pulpectomy assessed clinically and on periapical radiographs.
- Children having acute/chronic abcesses in teeth under consideration seen clinically.
- Children having furcal or periapical radiolucency around teeth under consideration seen on periapical radiograph.
- Diabetic, haemophilic or medically compromised children found on history
- Children who fail to attend appointments.
Trial locations and contacts
1 site in 1 country.
About this study
To provide an effective technique for pulpectomy in primary second molar teeth in pakistani population, local studies are required. No local studies have been done so far and limited number of international in vivo studies have been conducted previously. Hence this study will evaluate the effectiveness of this technique in pakistani population. If results of this study will be significant in favor of this technique, it will be applied with confidence in same population. There will be better compliance of patients as procedure will be done in single visit.
- Conditions
- Irreversible Pulpitis (toothache)
- Being tested
- Group B will be assigned to rotary instrumentation., will be assigned to rotary instrumentation.
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group B will be assigned to rotary instrumentation.Device
group B, NiTi rotary protaper system will be used for canal preparation by crown down technique.
will be assigned to rotary instrumentation.Device
the canal will be prepared by conventional hedstorm files manually by step back technique.
| Study group | Role | What they receive |
|---|---|---|
| Group A will be assigned to hand instrumentation. | Active comparator | the canal will be prepared by hand hedstorm files, manually by step back technique. Receives: Device: will be assigned to rotary instrumentation. |
| rotary instrumentation of primary second molar tooth | Experimental | NiTi rotary protaper system will be used for canal preparation by crown down technique in primary second molar tooth Receives: Device: Group B will be assigned to rotary instrumentation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effectiveness of manual versus rotary instrumentation for pulpectomy in primary second molar teeth irreversible pulpitis
Effectiveness of instruments will be determined by analyzing the adequacy of root canal filling. Adequacy will be checked immediately after root canal filling on periapical radiographs by measuring with scale the distance of root canal filling from apex to length of filling material in both mesial and distal roots. If distance is less than 2.5 mm, it will be called as effective.
Measured: immediately after obturation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Nov 2023
- Primary completion1 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible Pulpitis (toothache)Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- RANA AHMAD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, RANA AHMAD, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714305
- Sponsor's protocol ID
- CPSP/REU/2014-077-1257
- Status last verified
- Dec 2024
- First submitted
- 22 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Hand Versus Rotary Instrumentation in Pulpectomy of Primary Second Molar Teeth.
- ClinicalTrials.gov ID
- NCT06714305
- Acronym / sponsor ID
- CPSP/REU/2014-077-1257
- Conditions
- Irreversible Pulpitis (toothache)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- RANA AHMADUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 3 Dec 2024 (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.
To provide an effective technique for pulpectomy in primary second molar teeth in pakistani population, local studies are required. No local studies have been done so far and limited number of international in vivo studies have been conducted previously. Hence this study will evaluate the effectiveness of this technique in pakistani population. If results of this study will be significant in favor of this technique, it will be applied with confidence in same population. There will be better compliance of patients as procedure will be done in single visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A will be assigned to hand instrumentation. | Active comparator | Device: will be assigned to rotary instrumentation.the canal will be prepared by hand hedstorm files, manually by step back technique. |
| rotary instrumentation of primary second molar tooth | Experimental | Device: Group B will be assigned to rotary instrumentation.NiTi rotary protaper system will be used for canal preparation by crown down technique in primary second molar tooth |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children of both genders having age 4-6.5 years
- Children having signs and symptoms of irreversible pulpitis in their second primary molar teeth on clinical examination as per operational definition.
Key exclusion criteria (5 listed)
- Children having previously accessed pulpectomy assessed clinically and on periapical radiographs.
- Children having acute/chronic abcesses in teeth under consideration seen clinically.
- Children having furcal or periapical radiolucency around teeth under consideration seen on periapical radiograph.
- Diabetic, haemophilic or medically compromised children found on history
- Children who fail to attend appointments.
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 |
|---|---|---|
| Group B will be assigned to rotary instrumentation.group B, NiTi rotary protaper system will be used for canal preparation by crown down technique. | Device | rotary instrumentation of primary second molar tooth |
| will be assigned to rotary instrumentation.the canal will be prepared by conventional hedstorm files manually by step back technique. | Device | Group A will be assigned to hand instrumentation. |
Primary outcome
To compare the effectiveness of manual versus rotary instrumentation for pulpectomy in primary second molar teeth irreversible pulpitis
Time frame: immediately after obturation
Effectiveness of instruments will be determined by analyzing the adequacy of root canal filling. Adequacy will be checked immediately after root canal filling on periapical radiographs by measuring with scale the distance of root canal filling from apex to length of filling material in both mesial and distal roots. If distance is less than 2.5 mm, it will be called as effective.
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 5 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Irreversible Pulpitis (toothache)
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Active, not recruiting
Laser Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis
Irreversible Pulpitis (Toothache)
Recruiting
Local Dexamethasone Administration in Symptomatic Irreversible Pulpitis
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Recruiting
Predicting Vital Pulp Treatment Outcomes in Symptomatic Pulpits Using Metabolic Biomarker
Pulp Disease, Dental, Pulpitis
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 Group B will be assigned to rotary instrumentation. and will be assigned to rotary instrumentation. in people with Irreversible Pulpitis (toothache), run by RANA AHMAD at 1 site in Pakistan.
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 2 inclusion and 5 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 5 Dec 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 Pakistan. 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?
To compare the effectiveness of manual versus rotary instrumentation for pulpectomy in primary second molar teeth irreversible pulpitis (time frame: immediately after obturation). 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 5 Dec 2024.