Mandibular Molar Teeth With Symptomatic Irreversible PulpitisPhase 1NCT05927922
Effect of Preoperative Oral Ibuprofen on Anesthetic Efficacy of Inferior Alveolar Nerve Block With Supplemental Buccal and Lingual Infiltrations Using Articaine in Mandibular Molar Teeth With Irreversible Pulpitis
A Phase 1 study testing Oral Ibuprofen (Abbott, Egypt) in people with Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
Effect of preoperative oral Ibuprofen on anesthetic efficacy of inferior alveolar nerve block with supplemental buccal and lingual infiltrations using articaine in mandibular molar teeth with irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis
- What is being tested?
- Oral Ibuprofen (Abbott, Egypt)
- 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
- 1 siteEgypt
- Study dates
- 20 Jun 2023to 25 Jun 2024
- Phase
- Phase 1
- 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
- Males or females with age between 18-50 years.
- Systemically healthy patients (ASA I or II).
- patient's signs and symptoms give diagnosis of symptomatic irreversible pulpitis in mandibular molar teeth including: i. Presence of sharp pain upon thermal stimulus, lingering pain (often 30 seconds or longer after stimulus removal), spontaneity (unprovoked pain) and referred pain (According to American Association of Endodontics, 2013). According to Azim et al (2022), a clinical diagnosis for symptomatic irreversible pulpitis based on subjective (lingering pain to thermal changes for extended period).
- Pre-operative sharp pain marked on VAS scale by reading not less than 6. iii. exaggerated response with continuous lingering pain to cold pulp tester using ethyl chloride spray (Walter Ritter Gmbh +Co.-pharmaceutical - Germany. The Egyptian pharmaceutical trading company) and electric pulp tester (Denjoy dental CO., LTD.Changsha.P.R China).
- Normal periapical radiographic appearance or slight widening of the periodontal ligament space.
- v.Presence of objective findings such as caries or fracture, deep restorations. vi. No pain on percussion.
- -
Who cannot join
- Allergy to articaine or Ibuprofen
- History of intolerance to NSAIDs.
- Patients who have taken analgesics or anti-inflammatory drugs 12 hours before treatment.
- Patients with two or more adjacent teeth requiring endodontic treatment.
- Pregnant or nursing females.
- Teeth that have periodontal affection (with a pocket depth greater than 5mm, associated with swelling or fistulous tract, or greater than grade I mobility)
- Non-restorable teeth.
- Teeth fracture and resorption.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Oral Ibuprofen on Anesthetic Efficacy of Inferior Alveolar Nerve Block With Supplemental Buccal and Lingual Infiltrations Using Articaine in Mandibular Molar Teeth With Irreversible Pulpitis: A Randomized Controlled Double-blind Study
Effect of preoperative oral Ibuprofen on anesthetic efficacy of inferior alveolar nerve block with supplemental buccal and lingual infiltrations using articaine in mandibular molar teeth with irreversible pulpitis.
Read the detailed description
Control group: Placebo will be given 1 hour before IANB. Intervention group: Premedication with 600 mg of Oral Ibuprofen (Abbott, Egypt) will be given 1 hour before IANB.
A sequence of Procedural steps:
- Clinical and radiographic examination will be done for each tooth.
- Full medical and dental history will be obtained from all the patients participating in this study, patients will be checked for eligibility and will be informed about the study and sign consent form (Appendix 2) explaining the aim of the trial and the exact steps.
- Each patient will be given a pain scale chart (Appendix 3) and will be instructed on how to use it. Pre-operative pain level will be recorded.
- a tooth will be anesthetized using IANB by 3.6 ml of 4 % articaine with 1:100000 adrenaline (Artinibsa, Inibsa Co. for pharmaceuticals \& chemical industries, Spain) followed by 0.9mL BI and 0.9 mL LI of 4% articaine with 1:100000 adrenaline (Artinibsa, Inibsa Co. for pharmaceuticals \& chemical industries, Spain) using a standard dental aspirating syringe with a 27-G needle. After 15 minutes of the initial IANB, each patient will be asked if his or her lip is numb. If profound lip numbness is not recorded within 15 minutes, the block is considered unsuccessful, and the patients are excluded from the study. If lip numbness is recorded, the patients were further given BI and LI.
- In the control group: patients will be given a placebo 1 hour before I.A.N.B.
- In the intervention group: oral administration of 600 mg Ibuprofen (Abbott Pharma, Egypt.) will be given to the patients 1 hour before administration with IANB. After that, same procedures will be followed exactly as the control group.
- When full lip numbness appears, a sensitivity test for the tooth will be recorded. After 5 minutes from the supplemental injection, the involved teeth will be isolated with a rubber dam and a conventional access opening will be initiated. Patients will be instructed to raise their hand if any pain is felt during any stage of root canal treatment procedure. In case of pain, the procedure will be stopped, and patients will be asked to rate the pain on the VAS.
- Intraligamentry injection will be given to the patient who recorded Pain intensity greater than will be recorded as well as the step in which the patient felt pain.
- Root canal treatment procedures will be done as follow:
- Access cavity will be performed using a round bur and an endo-Z bur (DENTSPLY, Switzerland). The canals will be explored with #10, and #15 K-type hand files (Dentsply Maillefer, Ballaigues, Switzerland) according to the curvature and the initial root canal diameter using a watch-winding motion.
- The working length (WL) will be established using a Root ZX mini apex locator (J Morita Corp, Kyoto, Japan), and will be confirmed radiographically.
- The root canals will be thoroughly irrigated using 3ml syringe of 2.5% sodium hypochlorite (Clorox, 10th of Ramadan, Egypt) with irrigant flow rates ranging from 0.03 ml/sec to 1.27 ml/sec. after each instrument. A side vented needle (Diadent, Chungcheongbuk-do, Korea) will be used shorter than the working length by 1mm to control the possibility of irrigant apical extrusion.22
- Cleaning and shaping of all root canals will be carried out using M PRO (IMD, Shanghai, China) rotary files for both groups in a continuous rotary brushing motion, following the manufacturer's instructions. A gear reduction torque-controlled X-smart motor (Dentsply Maillefer, Maillefer, USA) will be used. For the first two-thirds of the working length, file (18/.09) served as an orifice opener in a continuous rotation motion with 500 rpm speed and 3 Ncm torque. Following that, (20/.04) and (25/.06) will be used respectively for the remaining working length at 500 rpm and 1.5 Ncm of torque. The files will be used in \& out motions of 3mm stroke length each time until reaching the working length. After using each file, the canal will be recapitulated and irrigated using 2 ml NaOCl. The apical portion of distal canals will be manually enlarged to size #35k file.
- Master cones selection will be done and confirmed radiography.
- Root canal irrigation will be done using saline followed by 3 ml 17% EDTA (META, Chungbuk, ROK) for 1 min to remove the smear layer.
- Canals will be dried using sterile paper points (Meta Biomed Co. Ltd, Korea), and then will be obturated using a resin-based sealer ADSEAL (META BIOMED Co., LTD., Chungbuuk, Korea) with the lateral compaction technique.
- The access cavity will then be closed with an intermediate restorative material (MD Temp temporary filling) to ensure a good coronal seal. A post-operative radiograph will be obtained.
- Adverse effects such as pain during and after injection will be recorded for each patient.
- Post-operative instructions will be given to all patients. • The patient will be asked to rate their post-operative pain level 6, 12, 24, and 48 hours postoperatively according to the given instructions and will be asked to return for a follow-up after 2 days to hand the pain scale chart (HP VAS scores)
Outcome:
Primary outcome:
The success rate of local anesthesia through measuring pain during root canal treatment using HP
VAS. It is a line numbered from 0-170mm, where pain levels are categorized as follows:
- "0" = no pain
- 1-54mm = faint, weak, or mild pain
- 55-114mm = moderate pain
- 114-170mm = strong, intense, or severe pain, "170mm" is the most intense pain. where success is defined as no or mild pain (0-54mm) throughout the procedure.
Secondary outcome:
Degree of postoperative pain using a modified visual analog scale. It is a line numbered from 0-10, where pain levels are categorized as follows:
- "0" = no pain
- 1-54mm = faint, weak, or mild pain
- 55-114mm = moderate pain
- 114-170mm = strong, intense, or severe pain, "170mm" is the most intense pain.
- Being tested
- Oral Ibuprofen (Abbott, Egypt)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Ibuprofen (Abbott, Egypt)Drug
ibuprofen is analegisic drug used to relieve pain
| Study group | Role | What they receive |
|---|---|---|
| Premedication with 600 mg of Oral Ibuprofen | Experimental | Premedication with 600 mg of Oral Ibuprofen (Abbott, Egypt) will be given 1 hour before IANB. Receives: Drug: Oral Ibuprofen (Abbott, Egypt) |
| Placebo will be given 1 hour before inferior alveolar nerve block | Placebo comparator | Not described Receives: Drug: Oral Ibuprofen (Abbott, Egypt) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of local anesthesia
Success rate of local anesthesia through measuring pain during root canal treatment using HP
VAS. It is a line numbered from 0-170mm, where pain levels are categorized as follows:
- "0" = no pain
- 1-54mm = faint, weak or mild pain
- 55-114mm = moderate pain
- 114-170mm = strong, intense or severe pain, "170mm" being the most intense pain conceivable. where success is defined as no or mild pain (0-54mm) throughout the procedure
Measured: During access cavity preparation and cleaning and shaping procedures of root canal treatment.
Secondary outcomes (1)
Degree of post-operative pain
Degree of post-operative pain using modified visual analogue scale. It is a line numbered from 0-10, where pain levels are categorized as follows:
- "0" = no pain
- 1-54mm = faint, weak or mild pain
- 55-114mm = moderate pain
- 114-170mm = strong, intense or severe pain, "170mm" being the most intense pain conceivable
Measured: 6, 12, 24 and 48 hours post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start20 Jun 2023
- Primary completion20 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular Molar Teeth With Symptomatic Irreversible PulpitisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Abd El hamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927922
- Sponsor's protocol ID
- ENDO 3/7/1
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Oral Ibuprofen on Anesthetic Efficacy of Inferior Alveolar Nerve Block With Supplemental Buccal and Lingual Infiltrations Using Articaine in Mandibular Molar Teeth With Irreversible Pulpitis: A Randomized Controlled Double-blind Study
- ClinicalTrials.gov ID
- NCT05927922
- Acronym / sponsor ID
- ENDO 3/7/1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 3 Jul 2023 (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.
Effect of preoperative oral Ibuprofen on anesthetic efficacy of inferior alveolar nerve block with supplemental buccal and lingual infiltrations using articaine in mandibular molar teeth with irreversible pulpitis.
Detailed description
Control group: Placebo will be given 1 hour before IANB. Intervention group: Premedication with 600 mg of Oral Ibuprofen (Abbott, Egypt) will be given 1 hour before IANB.
A sequence of Procedural steps:
- Clinical and radiographic examination will be done for each tooth.
- Full medical and dental history will be obtained from all the patients participating in this study, patients will be checked for eligibility and will be informed about the study and sign consent form (Appendix 2) explaining the aim of the trial and the exact steps.
- Each patient will be given a pain scale chart (Appendix 3) and will be instructed on how to use it. Pre-operative pain level will be recorded.
- a tooth will be anesthetized using IANB by 3.6 ml of 4 % articaine with 1:100000 adrenaline (Artinibsa, Inibsa Co. for pharmaceuticals \& chemical industries, Spain) followed by 0.9mL BI and 0.9 mL LI of 4% articaine with 1:100000 adrenaline (Artinibsa, Inibsa Co. for pharmaceuticals \& chemical industries, Spain) using a standard dental aspirating syringe with a 27-G needle. After 15 minutes of the initial IANB, each patient will be asked if his or her lip is numb. If profound lip numbness is not recorded within 15 minutes, the block is considered unsuccessful, and the patients are excluded from the study. If lip numbness is recorded, the patients were further given BI and LI.
- In the control group: patients will be given a placebo 1 hour before I.A.N.B.
- In the intervention group: oral administration of 600 mg Ibuprofen (Abbott Pharma, Egypt.) will be given to the patients 1 hour before administration with IANB. After that, same procedures will be followed exactly as the control group.
- When full lip numbness appears, a sensitivity test for the tooth will be recorded. After 5 minutes from the supplemental injection, the involved teeth will be isolated with a rubber dam and a conventional access opening will be initiated. Patients will be instructed to raise their hand if any pain is felt during any stage of root canal treatment procedure. In case of pain, the procedure will be stopped, and patients will be asked to rate the pain on the VAS.
- Intraligamentry injection will be given to the patient who recorded Pain intensity greater than will be recorded as well as the step in which the patient felt pain.
- Root canal treatment procedures will be done as follow:
- Access cavity will be performed using a round bur and an endo-Z bur (DENTSPLY, Switzerland). The canals will be explored with #10, and #15 K-type hand files (Dentsply Maillefer, Ballaigues, Switzerland) according to the curvature and the initial root canal diameter using a watch-winding motion.
- The working length (WL) will be established using a Root ZX mini apex locator (J Morita Corp, Kyoto, Japan), and will be confirmed radiographically.
- The root canals will be thoroughly irrigated using 3ml syringe of 2.5% sodium hypochlorite (Clorox, 10th of Ramadan, Egypt) with irrigant flow rates ranging from 0.03 ml/sec to 1.27 ml/sec. after each instrument. A side vented needle (Diadent, Chungcheongbuk-do, Korea) will be used shorter than the working length by 1mm to control the possibility of irrigant apical extrusion.22
- Cleaning and shaping of all root canals will be carried out using M PRO (IMD, Shanghai, China) rotary files for both groups in a continuous rotary brushing motion, following the manufacturer's instructions. A gear reduction torque-controlled X-smart motor (Dentsply Maillefer, Maillefer, USA) will be used. For the first two-thirds of the working length, file (18/.09) served as an orifice opener in a continuous rotation motion with 500 rpm speed and 3 Ncm torque. Following that, (20/.04) and (25/.06) will be used respectively for the remaining working length at 500 rpm and 1.5 Ncm of torque. The files will be used in \& out motions of 3mm stroke length each time until reaching the working length. After using each file, the canal will be recapitulated and irrigated using 2 ml NaOCl. The apical portion of distal canals will be manually enlarged to size #35k file.
- Master cones selection will be done and confirmed radiography.
- Root canal irrigation will be done using saline followed by 3 ml 17% EDTA (META, Chungbuk, ROK) for 1 min to remove the smear layer.
- Canals will be dried using sterile paper points (Meta Biomed Co. Ltd, Korea), and then will be obturated using a resin-based sealer ADSEAL (META BIOMED Co., LTD., Chungbuuk, Korea) with the lateral compaction technique.
- The access cavity will then be closed with an intermediate restorative material (MD Temp temporary filling) to ensure a good coronal seal. A post-operative radiograph will be obtained.
- Adverse effects such as pain during and after injection will be recorded for each patient.
- Post-operative instructions will be given to all patients. • The patient will be asked to rate their post-operative pain level 6, 12, 24, and 48 hours postoperatively according to the given instructions and will be asked to return for a follow-up after 2 days to hand the pain scale chart (HP VAS scores)
Outcome:
Primary outcome:
The success rate of local anesthesia through measuring pain during root canal treatment using HP
VAS. It is a line numbered from 0-170mm, where pain levels are categorized as follows:
- "0" = no pain
- 1-54mm = faint, weak, or mild pain
- 55-114mm = moderate pain
- 114-170mm = strong, intense, or severe pain, "170mm" is the most intense pain. where success is defined as no or mild pain (0-54mm) throughout the procedure.
Secondary outcome:
Degree of postoperative pain using a modified visual analog scale. It is a line numbered from 0-10, where pain levels are categorized as follows:
- "0" = no pain
- 1-54mm = faint, weak, or mild pain
- 55-114mm = moderate pain
- 114-170mm = strong, intense, or severe pain, "170mm" is the most intense pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premedication with 600 mg of Oral Ibuprofen | Experimental | Drug: Oral Ibuprofen (Abbott, Egypt)Premedication with 600 mg of Oral Ibuprofen (Abbott, Egypt) will be given 1 hour before IANB. |
| Placebo will be given 1 hour before inferior alveolar nerve block | Placebo comparator | Drug: Oral Ibuprofen (Abbott, Egypt) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males or females with age between 18-50 years.
- Systemically healthy patients (ASA I or II).
- patient's signs and symptoms give diagnosis of symptomatic irreversible pulpitis in mandibular molar teeth including: i. Presence of sharp pain upon thermal stimulus, lingering pain (often 30 seconds or longer after stimulus removal), spontaneity (unprovoked pain) and referred pain (According to American Association of Endodontics, 2013). According to Azim et al (2022), a clinical diagnosis for symptomatic irreversible pulpitis based on subjective (lingering pain to thermal changes for extended period).
- Pre-operative sharp pain marked on VAS scale by reading not less than 6. iii. exaggerated response with continuous lingering pain to cold pulp tester using ethyl chloride spray (Walter Ritter Gmbh +Co.-pharmaceutical - Germany. The Egyptian pharmaceutical trading company) and electric pulp tester (Denjoy dental CO., LTD.Changsha.P.R China).
- Normal periapical radiographic appearance or slight widening of the periodontal ligament space.
Key exclusion criteria (8 listed)
- Allergy to articaine or Ibuprofen
- History of intolerance to NSAIDs.
- Patients who have taken analgesics or anti-inflammatory drugs 12 hours before treatment.
- 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 |
|---|---|---|
| Oral Ibuprofen (Abbott, Egypt)ibuprofen is analegisic drug used to relieve pain | Drug | Placebo will be given 1 hour before inferior alveolar nerve block, Premedication with 600 mg of Oral Ibuprofen |
Primary outcome
Success rate of local anesthesia
Time frame: During access cavity preparation and cleaning and shaping procedures of root canal treatment.
Success rate of local anesthesia through measuring pain during root canal treatment using HP VAS. It is a line numbered from 0-170mm, where pain levels are categorized as follows: * "0" = no pain * 1-54mm = faint, weak or mild pain * 55-114mm = moderate pain * 114-170mm = strong, intense or severe pain, "170mm" being the most intense pain conceivable. where success is defined as no or mild pain (0-54mm) throughout the procedure
1 secondary outcome
Degree of post-operative pain
Time frame: 6, 12, 24 and 48 hours post-operatively.
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 8 Jul 2026.
- Individual participant dataSharing planned: Yes
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 Phase 1 study testing Oral Ibuprofen (Abbott, Egypt) in people with Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis, run by Cairo 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 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: finished, as of the sponsor's last update on 8 Jul 2026. 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. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Success rate of local anesthesia (time frame: During access cavity preparation and cleaning and shaping procedures of root canal treatment.). 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 8 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.