NeuritisNCT03493321
Role of PRF With MTA and Theracal After Pulpotomy in Relieving Pain
A study testing PRF with Theracal in people with Neuritis, run by Cairo University.
Trial summary
this research will evaluate the effect of PRF with different bioactive materials in dentistry Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuritis
- What is being tested?
- PRF with Theracal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 22 Aug 2019to 30 Sep 2019
- 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 16 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients suffering from Symptomatic pulpitis.
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- Patients who will agree to the consent and will commit to follow-up period.
- Patients with mature root.
- Patients with no periapical lesion.
- Patients with localized pain.
- Posterior teeth only will be involved
Who cannot join
- Patients with immature roots.
- Patients with any systemic disease that may affect normal healing.
- Patients with periapical lesions or infections.
- Pregnant females.
- Patients who could/would not participate in a 1-year follow-up.
- Patients with fistula.
- Patients with necrotic pulp.
- Patients with old age.
About this study
Official title: Role of PRF With MTA and Theracal After Pulpotomy in Relieving Pain and Maintaining the Vitality of the Remaining Radicular Pulp Tissue in Permanent Posterior Teeth With Closed Root Apices: "Randomized Controlled Trial"
this research will evaluate the effect of PRF with different bioactive materials in dentistry
Read the detailed description
PRF will be used with MTA and Theracal to evaluate its effect upon these materials in reliving pain and maintains the teeth vitality in permanent teeth with closed apices, in order to improve the materials outcome.
- Conditions
- Neuritis
- Being tested
- PRF with Theracal
- Medical subject headings
- Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRF with TheracalOther
using the PRF which is a new technique with an bioactive material which is the Theracal to evaluate its effect upon the radicular pulp tissue
| Study group | Role | What they receive |
|---|---|---|
| PRF with MTA | Experimental | PRF with MTA with PRF with Theracal as intervention Receives: Other: PRF with Theracal |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain after the process
Questionnaire by asking the patient about the pain intensity
Measured: 1 year
Secondary outcomes (2)
dentin bridge formation
X-ray
Measured: 1 year
no periapical radiolucency
X-ray
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 posted10 Apr 2018
- Study start22 Aug 2019 (estimated)
- Primary completion22 Aug 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuritisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Essam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493321
- Sponsor's protocol ID
- CEBD-CU-2018-03-07
- Status last verified
- Aug 2019
- First submitted
- 12 Mar 2018
- Last updated
- 20 Aug 2019
- 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 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of PRF With MTA and Theracal After Pulpotomy in Relieving Pain and Maintaining the Vitality of the Remaining Radicular Pulp Tissue in Permanent Posterior Teeth With Closed Root Apices: "Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT03493321
- Acronym / sponsor ID
- CEBD-CU-2018-03-07
- Conditions
- Neuritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Aug 2019 (estimated)
- Primary completion
- 22 Aug 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 10 Apr 2018 (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.
this research will evaluate the effect of PRF with different bioactive materials in dentistry
Detailed description
PRF will be used with MTA and Theracal to evaluate its effect upon these materials in reliving pain and maintains the teeth vitality in permanent teeth with closed apices, in order to improve the materials outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRF with MTA | Experimental | Other: PRF with TheracalPRF with MTA with PRF with Theracal as intervention |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patients suffering from Symptomatic pulpitis.
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- Patients who will agree to the consent and will commit to follow-up period.
- Patients with mature root.
- Patients with no periapical lesion.
Key exclusion criteria (8 listed)
- Patients with immature roots.
- Patients with any systemic disease that may affect normal healing.
- Patients with periapical lesions or infections.
- Pregnant females.
- Patients who could/would not participate in a 1-year follow-up.
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 |
|---|---|---|
| PRF with Theracalusing the PRF which is a new technique with an bioactive material which is the Theracal to evaluate its effect upon the radicular pulp tissue | Other | PRF with MTA |
Primary outcome
pain after the process
Time frame: 1 year
Questionnaire by asking the patient about the pain intensity
2 secondary outcomes
dentin bridge formation
Time frame: 1 year
no 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 20 Aug 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing PRF with Theracal in people with Neuritis, 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 8 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 20 Aug 2019. 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?
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?
pain after the process (time frame: 1 year). 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 20 Aug 2019.