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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Egypt1 site
  • faculty of dentistry Cairo university

    Cairo, Cairo Governorate

Other trials in Egypt

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:

  1. Clinical and radiographic examination will be done for each tooth.
  2. 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.
  3. 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.
  4. 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.
  5. In the control group: patients will be given a placebo 1 hour before I.A.N.B.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  1. 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.
  2. Adverse effects such as pain during and after injection will be recorded for each patient.
  3. 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 groups in NCT05927922
Study groupRoleWhat they receive
Premedication with 600 mg of Oral IbuprofenExperimentalPremedication 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 blockPlacebo comparatorNot described
Receives: Drug: Oral Ibuprofen (Abbott, Egypt)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted3 Jul 2023
  2. Study start20 Jun 2023
  3. Primary completion20 Jun 2024
  4. Study completion25 Jun 2024

Resources

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)
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

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.

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