Post Operative PainNCT05475795
Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials
A study testing Metapex and Endoflas in people with Post Operative Pain, run by Minia University at 1 site in Egypt.
Trial summary
Testing postopertive pain after pulpectomy of primary molars with Metapex and Endoflas using modified Wong-Baker scale of pain. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Metapex and Endoflas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jun 2022to 16 Jan 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3.1. Inclusion criteria: The study will include children who meet the following clinical and radiographic criteria:
- Clinical:
- 5-7-year old children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
- Children rated as no.3 or 4 in Frankel behavior rating scale (FBRS).
- Presence of at least one primary molar with deep carious lesion.
- Asymptomatic necrotic molars confirmed by the absence of bleeding on opening of the pulp chamber.
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- Radiographic:
- Extensive caries approaching to the pulp.
- Presence of at least two-thirds of root length.
Who cannot join
- A child's tooth with any of the following criteria:
- Clinical findings:
- History of spontaneous unprovoked toothache.
- Extensive crown destruction that preclude coronal restoration.
- Presence of adjacent or opposing tooth with deep carious lesion "in the same side".
- History of administering analgesics 12 hours before tooth obturation.
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- Radiographic findings:
- Presence of a large furcation or periapical radiolucency approximating the succedaneous tooth.
- Presence of pathological internal/external root resorption.
- Absence of underlying permanent successor.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Nada Mohamed Hassan Saied
Minya, 61511
Nada M Hassan, 00201116889844, nadooshaa66@gmail.com
About this study
Official title: Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials: A Parallel Randomized Clinical Trial
Testing postopertive pain after pulpectomy of primary molars with Metapex and Endoflas using modified Wong-Baker scale of pain.
Read the detailed description
The current equivalent parallel randomized controlled trial will be conducted to evaluate intensity and duration of post-operative pain after pulpectomy of asymptomatic necrotic primary molars, using Metapex and Endoflas obturation materials
- Conditions
- Post Operative Pain
- Being tested
- Metapex, Endoflas
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetapexOther
obturation of root canals of primary molars with Metapex
EndoflasOther
obturation of root canals of primary molars with Endoflas
| Study group | Role | What they receive |
|---|---|---|
| Metapex group | Active comparator | Obturation of primary molars with calcium hydroxide and iodoform paste Receives: Other: Metapex; Other: Endoflas |
| Endoflas group | Experimental | Obturation of primary molars with calcium hydroxide, eugenol and iodoform paste Receives: Other: Metapex; Other: Endoflas |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain.
Measuring post operative pain after pulpectomy with two different obturation materials using (Modified Wong-backer scale of pain )which have four scales from( 0 to 3) which 0 is the better outcome( no pain) and 3 is the worst (severe pain).
Measured: after one day and after one week .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start9 Jun 2022
- Primary completion15 Dec 2022 (estimated)
- Study completion16 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Mohamed Hassan, Minia University
- Investigators
- Osama S Gad El-Hak, PhD, Study director, Pediatric Dentistry Department, Faculty of Dentistry, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475795
- Sponsor's protocol ID
- 576-2022
- Status last verified
- Jul 2022
- First submitted
- 24 Jul 2022
- Last updated
- 2 Aug 2022
- 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 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials: A Parallel Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05475795
- Acronym / sponsor ID
- 576-2022
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 16 Jan 2023 (estimated)
- First posted
- 27 Jul 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.
Testing postopertive pain after pulpectomy of primary molars with Metapex and Endoflas using modified Wong-Baker scale of pain.
Detailed description
The current equivalent parallel randomized controlled trial will be conducted to evaluate intensity and duration of post-operative pain after pulpectomy of asymptomatic necrotic primary molars, using Metapex and Endoflas obturation materials
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metapex group | Active comparator | Other: Metapex, Other: EndoflasObturation of primary molars with calcium hydroxide and iodoform paste |
| Endoflas group | Experimental | Other: Metapex, Other: EndoflasObturation of primary molars with calcium hydroxide, eugenol and iodoform paste |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 3.1. Inclusion criteria: The study will include children who meet the following clinical and radiographic criteria:
- 5-7-year old children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
- Children rated as no.3 or 4 in Frankel behavior rating scale (FBRS).
- Presence of at least one primary molar with deep carious lesion.
- Asymptomatic necrotic molars confirmed by the absence of bleeding on opening of the pulp chamber.
Key exclusion criteria (10 listed)
- A child's tooth with any of the following criteria:
- History of spontaneous unprovoked toothache.
- Extensive crown destruction that preclude coronal restoration.
- Presence of adjacent or opposing tooth with deep carious lesion "in the same side".
- History of administering analgesics 12 hours before tooth obturation.
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 |
|---|---|---|
| Metapexobturation of root canals of primary molars with Metapex | Other | Endoflas group, Metapex group |
| Endoflasobturation of root canals of primary molars with Endoflas | Other | Endoflas group, Metapex group |
Primary outcome
postoperative pain.
Time frame: after one day and after one week .
Measuring post operative pain after pulpectomy with two different obturation materials using (Modified Wong-backer scale of pain )which have four scales from( 0 to 3) which 0 is the better outcome( no pain) and 3 is the worst (severe pain).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
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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.
Osama S Gad El-Hak, PhD study director
Pediatric Dentistry Department, Faculty of Dentistry, Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metapex and Endoflas in people with Post Operative Pain, 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 9 inclusion and 10 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 2 Aug 2022. 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 Osama S Gad El-Hak (00201023449797, osama.seif@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain. (time frame: after one day and after one 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 2 Aug 2022.