Symptomatic Irreversible PulpitsNCT04599244
Effect of Emergency Pulpotomy Versus Pulp Extirpation on Anesthetic Efficacy in Endodontic Treatment of Acute Pulpitis
A study testing emergency pulpotomy in people with Symptomatic Irreversible Pulpits, run by Cairo University.
Trial summary
Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful, and one of the main reasons for seeking emergency dental treatment. Pain associated with irreversible pulpitis represents more than 45% of emergency patients in dental clinics. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpits
- What is being tested?
- emergency pulpotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Dec 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are medically free from any systemic disease that may contra indicate our interventions.
- Patient's age between 18-65 years old.
- Mandibular molar having vital pulps with symptomatic irreversible pulpitis because this group of patients may have more endodontic pain
- Positive patient's acceptance for participation in the study.
Who cannot join
- - Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment to give true response of pain during treatment.
- Teeth with necrotic pulp.
- Pregnant patients or lactating because of radiographic hazards and use of analgesics.
- Any known sensitivity or adverse reactions to ibuprofen.
About this study
Official title: Assessment of the Effect of Emergency Pulpotomy Versus Complete Pulp Extirpation on Anesthetic Efficacy in Endodontic Treatment of Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful, and one of the main reasons for seeking emergency dental treatment. Pain associated with irreversible pulpitis represents more than 45% of emergency patients in dental clinics. A pulpotomy has been demonstrated as an emergency intervention for effective pain relief by removing the coronal pulp tissue without penetrating radicular pulpal tissue. Inflammation and degeneration of the pulp usually progress apically from the point of infection, so selective removal of this tissue in the form of pulpotomy is usually effective in controlling pain and patient sedation.
The rationale behind emergency pulpotomy is relieving acute dental pain caused by irreversible pulpitis. However, there is still insufficient evidence to determine whether the presence, nature and duration of clinical symptoms gives accurate information about the extent of pulp inflammation, as pulpotomy was found to be an effective emergency treatment strategy with respect to relieving clinical symptoms, even in cases of irreversible pulpitis with symptomatic apical periodontitis . Advanced diagnostic strategies are needed to determine whether there is a correlation between clinical symptoms, actual pulpal inflammation and achieving adequate pain relief during and after treatment. Thus, we are conducting this study to assess the effect of emergency pulpotomy versus complete pulp extirpation on relieving acute dental pain of symptomatic irreversible pulpitis in mandibular molars. The expected benefit for the patients is to decrease pain during and after treatment. we also are trying to provide an evidence for the clinician in order to provide the best endodontic treatment without pain.
Read the detailed description
Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful, and one of the main reasons for seeking emergency dental treatment. Pain associated with irreversible pulpitis represents more than 45% of emergency patients in dental clinics. A pulpotomy has been demonstrated as an emergency intervention for effective pain relief by removing the coronal pulp tissue without penetrating radicular pulpal tissue. Inflammation and degeneration of the pulp usually progress apically from the point of infection, so selective removal of this tissue in the form of pulpotomy is usually effective in controlling pain and patient sedation.
- Conditions
- Symptomatic Irreversible Pulpits
- Being tested
- emergency pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emergency pulpotomyOther
removal of coronal pulp
| Study group | Role | What they receive |
|---|---|---|
| emergency pulpotomy | Experimental | intervention arm Receives: Other: emergency pulpotomy |
| complete pulp extirpation | Active comparator | control arm Receives: Other: emergency pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
anesthetic efficacy
measured byVerbal rating scale (VRS),unit:Binary (success/failure)
Measured: During pulp extirpation and pulpotomy (30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible PulpitsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599244
- Sponsor's protocol ID
- 3-3-5
- Status last verified
- Oct 2020
- First submitted
- 14 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Emergency Pulpotomy Versus Complete Pulp Extirpation on Anesthetic Efficacy in Endodontic Treatment of Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04599244
- Acronym / sponsor ID
- 3-3-5
- Conditions
- Symptomatic Irreversible Pulpits
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 22 Oct 2020 (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.
Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful, and one of the main reasons for seeking emergency dental treatment. Pain associated with irreversible pulpitis represents more than 45% of emergency patients in dental clinics. A pulpotomy has been demonstrated as an emergency intervention for effective pain relief by removing the coronal pulp tissue without penetrating radicular pulpal tissue. Inflammation and degeneration of the pulp usually progress apically from the point of infection, so selective removal of this tissue in the form of pulpotomy is usually effective in controlling pain and patient sedation.
The rationale behind emergency pulpotomy is relieving acute dental pain caused by irreversible pulpitis. However, there is still insufficient evidence to determine whether the presence, nature and duration of clinical symptoms gives accurate information about the extent of pulp inflammation, as pulpotomy was found to be an effective emergency treatment strategy with respect to relieving clinical symptoms, even in cases of irreversible pulpitis with symptomatic apical periodontitis . Advanced diagnostic strategies are needed to determine whether there is a correlation between clinical symptoms, actual pulpal inflammation and achieving adequate pain relief during and after treatment. Thus, we are conducting this study to assess the effect of emergency pulpotomy versus complete pulp extirpation on relieving acute dental pain of symptomatic irreversible pulpitis in mandibular molars. The expected benefit for the patients is to decrease pain during and after treatment. we also are trying to provide an evidence for the clinician in order to provide the best endodontic treatment without pain.
Detailed description
Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful, and one of the main reasons for seeking emergency dental treatment. Pain associated with irreversible pulpitis represents more than 45% of emergency patients in dental clinics. A pulpotomy has been demonstrated as an emergency intervention for effective pain relief by removing the coronal pulp tissue without penetrating radicular pulpal tissue. Inflammation and degeneration of the pulp usually progress apically from the point of infection, so selective removal of this tissue in the form of pulpotomy is usually effective in controlling pain and patient sedation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| emergency pulpotomy | Experimental | Other: emergency pulpotomyintervention arm |
| complete pulp extirpation | Active comparator | Other: emergency pulpotomycontrol arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are medically free from any systemic disease that may contra indicate our interventions.
- Patient's age between 18-65 years old.
- Mandibular molar having vital pulps with symptomatic irreversible pulpitis because this group of patients may have more endodontic pain
- Positive patient's acceptance for participation in the study.
Key exclusion criteria (4 listed)
- - Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment to give true response of pain during treatment.
- Teeth with necrotic pulp.
- Pregnant patients or lactating because of radiographic hazards and use of analgesics.
- Any known sensitivity or adverse reactions to ibuprofen.
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 |
|---|---|---|
| emergency pulpotomyremoval of coronal pulp | Other | complete pulp extirpation, emergency pulpotomy |
Primary outcome
anesthetic efficacy
Time frame: During pulp extirpation and pulpotomy (30 minutes)
measured byVerbal rating scale (VRS),unit:Binary (success/failure)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Symptomatic Irreversible Pulpits
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.
Questions about this trial
What is this clinical trial studying?
A study testing emergency pulpotomy in people with Symptomatic Irreversible Pulpits, 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 4 inclusion and 4 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 22 Oct 2020. 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?
anesthetic efficacy (time frame: During pulp extirpation and pulpotomy (30 minutes)). 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 22 Oct 2020.