Pulp NecrosesNCT05057325
Post Operative Pain Assessment After Pulpectomy of Primary Molars With Two Different Rotary Systems
A study testing Pulpectomy using single file system ( One Shape file) and Pulpectomy using single file system ( WaveOne Gold file) in people with Pulp Necroses, run by Minia University at 1 site in Egypt.
Trial summary
Evaluation of post operative pain after pulpectomy procedures for primary molars with irreversible pulp damage and without periapical radulicency using two different systems (One shape file ( ratation movemont) and wave one gold file ( reciprocation movement) Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Necroses
- What is being tested?
- Pulpectomy using single file system ( One Shape file) and Pulpectomy using single file system ( WaveOne Gold file)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2021to 10 Jun 2021
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age of more than 4 years
- Healthy children
- Primary molars with irreversible pulp damage
Who cannot join
- Presence of periapical radiolucency realtes to primary molar
- Uncooperative child
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Operative Pain After Pulpectomy of Primary Molars With One Shap Rotation File Versus Wave One Reciprocating File
Evaluation of post operative pain after pulpectomy procedures for primary molars with irreversible pulp damage and without periapical radulicency using two different systems (One shape file ( ratation movemont) and wave one gold file ( reciprocation movement)
- Conditions
- Pulp Necroses
- Being tested
- Pulpectomy using single file system ( One Shape file), Pulpectomy using single file system ( WaveOne Gold file)
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulpectomy using single file system ( One Shape file)Other
Rotary file instrument for pulpectomy of primary molars ( One shape file)
Pulpectomy using single file system ( WaveOne Gold file)Other
Rotary file instrument for pulpectomy of primary molars ( WaveOne Gold file)
| Study group | Role | What they receive |
|---|---|---|
| Wave One Gold | Experimental | Receporcating single file used for preparation of root canals in primary molars Receives: Other: Pulpectomy using single file system ( WaveOne Gold file) |
| One shape | Experimental | Rotation single file used for preparation of root canals in primary molars Receives: Other: Pulpectomy using single file system ( One Shape file) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Assessment of pain using 4 piont intensity scale
1 means no pain, 2 means slight pain, 3 means moderate pain and for means sever pain at 6,12, 48,72 hours and 1 week
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start10 Jan 2021
- Primary completion10 May 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp NecrosesStudies of the same condition, open and under way.
- More trials run by Minia 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Mahmoud, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057325
- Sponsor's protocol ID
- 605
- Status last verified
- Aug 2021
- First submitted
- 30 Aug 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Pain After Pulpectomy of Primary Molars With One Shap Rotation File Versus Wave One Reciprocating File
- ClinicalTrials.gov ID
- NCT05057325
- Acronym / sponsor ID
- 605
- Conditions
- Pulp Necroses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 27 Sep 2021 (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.
Evaluation of post operative pain after pulpectomy procedures for primary molars with irreversible pulp damage and without periapical radulicency using two different systems (One shape file ( ratation movemont) and wave one gold file ( reciprocation movement)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wave One Gold | Experimental | Other: Pulpectomy using single file system ( WaveOne Gold file)Receporcating single file used for preparation of root canals in primary molars |
| One shape | Experimental | Other: Pulpectomy using single file system ( One Shape file)Rotation single file used for preparation of root canals in primary molars |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age of more than 4 years
- Healthy children
- Primary molars with irreversible pulp damage
Key exclusion criteria (2 listed)
- Presence of periapical radiolucency realtes to primary molar
- Uncooperative child
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 |
|---|---|---|
| Pulpectomy using single file system ( One Shape file)Rotary file instrument for pulpectomy of primary molars ( One shape file) | Other | One shape |
| Pulpectomy using single file system ( WaveOne Gold file)Rotary file instrument for pulpectomy of primary molars ( WaveOne Gold file) | Other | Wave One Gold |
Primary outcome
Post operative pain
Time frame: 1 week
Assessment of pain using 4 piont intensity scale 1 means no pain, 2 means slight pain, 3 means moderate pain and for means sever pain at 6,12, 48,72 hours and 1 week
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 27 Sep 2021.
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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 Pulpectomy using single file system ( One Shape file) and Pulpectomy using single file system ( WaveOne Gold file) in people with Pulp Necroses, run by Minia 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 3 inclusion and 2 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 27 Sep 2021. 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?
Post operative pain (time frame: 1 week). 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 Sep 2021.