AnesthesiaNCT05053009
Effect of Ibuprofen Sustained Release on Intraoperative and Postoperative Pain in Mandibular Molars
A study testing Brufen Retard in people with Anesthesia, run by Cairo University.
Trial summary
The study is conducted to evaluate the effect of Ibuprofen sustained release premedication on the success of buccal infiltration anaesthesia, intaroperative pain and post operative pain in mandibular molars with symptomatic irreversible pulpitis and apical periodontitis Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Brufen Retard
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Oct 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy patients (ASA I or II).
- Patients with Mandibular molar teeth diagnosed with:
- Pre-operative sharp pain marked on VAS scale by reading not less than 6.
- Vital exaggerated response of pulp tissue to cold pulp tester (ethyl chloride spray) and electric pulp tester.
- Normal periapical radiographic appearance or slight widening in lamina dura.
- Positive response and pain provoked by percussion.
Who cannot join
- Allergy to Ibuprofen
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- History of intolerance to NSAIDS.
- Patients with two or more adjacent teeth requiring endodontic treatment.
- Pregnant or nursing females.
- Teeth that have:
- Periodontal affection (with pocket depth greater than 5mm, associated with swelling or fistulous tract, or greater than grade I mobility)
- No possible restorability.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Ibuprofen Sustained Release Oral Premedication on Intraoperative and Postoperative Pain After Single-visit Root Canal Treatment of Mandibular Molars With Symptomatic Irreversible Pulpitis and Apical Periodontitis
The study is conducted to evaluate the effect of Ibuprofen sustained release premedication on the success of buccal infiltration anaesthesia, intaroperative pain and post operative pain in mandibular molars with symptomatic irreversible pulpitis and apical periodontitis
- Conditions
- Anesthesia
- Being tested
- Brufen Retard
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brufen RetardDrug
800 mg tablet of Brufen Retard will be adminstered orally one hour before local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen sustained release | Experimental | Single dose of 800 mg Brufen Retard oral premedication will be administered 1 hour before local anesthesia Receives: Drug: Brufen Retard |
| Placebo | Placebo comparator | 1 capsule of 500 mg of glucose oral premedication will be adminstered 1 hour before local anesthesia Receives: Drug: Brufen Retard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of buccal infiltration anaesthesia measured using Visual analogue scale
intensity of pain during root canal treatment procedures is recorded by the patient using VAS where 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain
Measured: During root canal treatment procedures
Secondary outcomes (3)
Intensity of intraoperative pain
intensity of pain during root canal treatment procedures is recorded by the patient using VAS where 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain
Measured: During root canal treatment procedures
Postoperative pain
Intensity of pain felt after endodontic treatment recorded by the patient using VAS where 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain
Measured: up to 48 hours after endodontic treatment
Number of needed analgesic tablets in case of intolerable pain
The patient will record the number of analgesic tablets taken in case of intolerable pain
Measured: up to 48 hours after endodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study startNov 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Ahmed Hossam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053009
- Sponsor's protocol ID
- ENDO3-7-1
- Status last verified
- Sep 2021
- First submitted
- 11 Sep 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ibuprofen Sustained Release Oral Premedication on Intraoperative and Postoperative Pain After Single-visit Root Canal Treatment of Mandibular Molars With Symptomatic Irreversible Pulpitis and Apical Periodontitis
- ClinicalTrials.gov ID
- NCT05053009
- Acronym / sponsor ID
- ENDO3-7-1
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 22 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.
The study is conducted to evaluate the effect of Ibuprofen sustained release premedication on the success of buccal infiltration anaesthesia, intaroperative pain and post operative pain in mandibular molars with symptomatic irreversible pulpitis and apical periodontitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen sustained release | Experimental | Drug: Brufen RetardSingle dose of 800 mg Brufen Retard oral premedication will be administered 1 hour before local anesthesia |
| Placebo | Placebo comparator | Drug: Brufen Retard1 capsule of 500 mg of glucose oral premedication will be adminstered 1 hour before local anesthesia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Systemically healthy patients (ASA I or II).
- Patients with Mandibular molar teeth diagnosed with:
Key exclusion criteria (8 listed)
- Allergy to Ibuprofen
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- History of intolerance to NSAIDS.
- Patients with two or more adjacent teeth requiring endodontic treatment.
- Pregnant or nursing females.
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 |
|---|---|---|
| Brufen Retard800 mg tablet of Brufen Retard will be adminstered orally one hour before local anesthesia | Drug | Ibuprofen sustained release, Placebo |
Primary outcome
Efficacy of buccal infiltration anaesthesia measured using Visual analogue scale
Time frame: During root canal treatment procedures
intensity of pain during root canal treatment procedures is recorded by the patient using VAS where 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain
3 secondary outcomes
Intensity of intraoperative pain
Time frame: During root canal treatment procedures
Postoperative pain
Time frame: up to 48 hours after endodontic treatment
Number of needed analgesic tablets in case of intolerable pain
Time frame: up to 48 hours after endodontic treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Questions about this trial
What is this clinical trial studying?
A study testing Brufen Retard in people with Anesthesia, 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 6 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 22 Sep 2021. 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. Some participants in this study may receive a placebo. 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 Mariam Ah Hossam, B.D.S (01110913251 ext. 002, mariam.ahmed.hosam@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of buccal infiltration anaesthesia measured using Visual analogue scale (time frame: During root canal treatment procedures). 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 Sep 2021.