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PulpitisPhase 3NCT07919938

Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars

A Phase 3 study testing Articaine Hydrochloride With Epinephrine, Submucosal Cryotherapy and Diclofenac Sodium in people with Pulpitis, run by Suez Canal University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Pain after root canal treatment is a common problem, particularly in teeth with symptomatic irreversible pulpitis, a condition involving severe inflammation of the tissue inside the tooth. Read more about this study

Who is it for?
Ages 21 to 50 years
Conditions the study is for
Pulpitis
What is being tested?
Articaine Hydrochloride With Epinephrine, Submucosal Cryotherapy and Diclofenac Sodium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
15 Nov 2026to 15 Nov 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 21 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult patients aged 21-50 years.
  • Maxillary first or second molars diagnosed with symptomatic irreversible pulpitis.
  • Teeth with mature roots and normal apical tissues or without radiographic evidence of apical pathosis.
  • Vital teeth exhibiting an exaggerated and lingering response to thermal stimuli.
  • Patients experiencing moderate to severe preoperative pain.
  • Patients classified as American Society of Anesthesiologists (ASA) physical status I or II.
  • Teeth considered restorable and suitable for rubber dam isolation.

Who cannot join

  • Patients with known hypersensitivity or allergy to articaine, diclofenac sodium, dexamethasone, or any materials used in the study.
  • Patients who have received analgesics, anti-inflammatory drugs, corticosteroids, or antibiotics within the preceding 48-72 hours.
  • Pregnant or lactating women.
  • Medically compromised patients or those receiving immunosuppressive therapy.
  • Teeth with periapical lesions, swelling, sinus tracts, tenderness to percussion, or symptomatic apical periodontitis.
  • Previously initiated or previously treated teeth.
  • Teeth with periodontal pockets, root resorption, calcified canals, or non-restorable coronal structures.
  • Cases involving procedural complications, including perforation, instrument separation, or inability to complete root canal treatment according to the standardized protocol.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site
  • Endodontics Department, Faculty of Dentistry, Suez Canal University

    Ismailia, Ismailia Governorate, 41522

    Hisham E El- Sayed, MSc, 0 10 92192763 ext. +2, hesham_elsayed@dent.suez.edu.eg

Other trials in Egypt

About this study

Official title: Effect of Submucosal Cryotherapy With or Without Different Anti-inflammatory Drugs on Postoperative Pain and Interleukin-6 Levels in Maxillary Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Study

Pain after root canal treatment is a common problem, particularly in teeth with symptomatic irreversible pulpitis, a condition involving severe inflammation of the tissue inside the tooth. Submucosal cryotherapy, which involves applying cold saline through an injection near the affected tooth, may help reduce postoperative pain and inflammation. Anti-inflammatory medications, such as diclofenac sodium and dexamethasone, may also provide pain relief.

This randomized clinical trial aims to evaluate the effects of submucosal cryotherapy, alone or combined with anti-inflammatory medications, on postoperative pain and interleukin-6 (IL-6) levels in patients undergoing root canal treatment of upper molars with symptomatic irreversible pulpitis.

Read more

A total of 90 adult patients will be randomly assigned to six groups: local anesthesia alone, cryotherapy with anesthesia, diclofenac sodium with anesthesia, dexamethasone with anesthesia, cryotherapy combined with diclofenac sodium, or cryotherapy combined with dexamethasone. All participants will undergo standardized single-visit root canal treatment.

Postoperative pain will be evaluated during the first 72 hours after treatment. IL-6, a substance involved in inflammation, will be measured in blood samples collected from the dental pulp during treatment. The need for additional pain medication and the occurrence of postoperative flare-ups will also be assessed.

The study seeks to determine whether combining submucosal cryotherapy with anti-inflammatory medications provides greater postoperative pain relief than individual interventions or standard care alone.

Conditions
Pulpitis
Being tested
Articaine Hydrochloride With Epinephrine, Submucosal Cryotherapy, Diclofenac Sodium, Dexamethasone Sodium Phosphate
Keywords
Symptomatic Irreversible Pulpitis, Submucosal Cryotherapy, Root Canal Treatment, Endodontic Pain, Diclofenac Sodium, Dexamethasone Sodium Phosphate, Interleukin-6, Postoperative Pain Management
Medical subject headings
Pulpitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Articaine Hydrochloride With EpinephrineDrug

    Local anesthesia will be administered using one carpule of 4% articaine hydrochloride with epinephrine 1:100,000 by buccal infiltration before single-visit root canal treatment. Supplemental palatal infiltration will be provided if needed, and any additional anesthetic administration will be recorded. This standard anesthetic regimen will be used in all six study groups.

  • Submucosal CryotherapyProcedure or surgery

    Submucosal cryotherapy will be performed through a single injection of 1 mL sterile normal saline cooled to 2-5°C into the buccal vestibule adjacent to the affected maxillary molar before root canal treatment. The intervention is intended to provide localized cooling to reduce postoperative inflammation and pain. Cryotherapy will be administered alone or in combination with an anti-inflammatory drug according to group allocation.

  • Diclofenac SodiumDrug

    Diclofenac sodium will be administered as a single preoperative submucosal injection of 1 mL at a concentration of 25 mg/mL (total dose: 25 mg) into the buccal vestibule adjacent to the affected maxillary molar. It will be administered alone or in combination with submucosal cryotherapy according to group allocation to evaluate its effects on postoperative pain and inflammatory response.

  • Dexamethasone Sodium PhosphateDrug

    Dexamethasone sodium phosphate will be administered as a single preoperative submucosal injection of 1 mL at a concentration of 4 mg/mL (total dose: 4 mg) into the buccal vestibule adjacent to the affected maxillary molar. It will be administered alone or in combination with submucosal cryotherapy according to group allocation to evaluate its effects on postoperative pain and inflammatory response.

Study groups in NCT07919938
Study groupRoleWhat they receive
Anesthesia Alone (Control Group)Active comparatorParticipants will receive local anesthesia using one carpule of 4% articaine hydrochloride with epinephrine 1:100,000 administered by buccal infiltration, with supplemental palatal infiltration if needed. Standardized single-visit root canal treatment will be performed without additional submucosal cryotherapy or anti-inflammatory drug injections.
Receives: Drug: Articaine Hydrochloride With Epinephrine
Submucosal Cryotherapy With AnesthesiaExperimentalParticipants will receive standard local anesthesia followed by a single submucosal injection of 1 mL cold normal saline (2-5°C) into the buccal vestibule adjacent to the affected maxillary molar before standardized single-visit root canal treatment.
Receives: Drug: Articaine Hydrochloride With Epinephrine; Procedure: Submucosal Cryotherapy
Diclofenac Sodium With AnesthesiaExperimentalParticipants will receive standard local anesthesia followed by a single submucosal injection of 1 mL diclofenac sodium (25 mg/mL; total dose 25 mg) into the buccal vestibule adjacent to the affected maxillary molar before standardized single-visit root canal treatment.
Receives: Drug: Articaine Hydrochloride With Epinephrine; Drug: Diclofenac Sodium
Dexamethasone With AnesthesiaExperimentalParticipants will receive standard local anesthesia followed by a single submucosal injection of 1 mL dexamethasone sodium phosphate (4 mg/mL; total dose 4 mg) into the buccal vestibule adjacent to the affected maxillary molar before standardized single-visit root canal treatment.
Receives: Drug: Articaine Hydrochloride With Epinephrine; Drug: Dexamethasone Sodium Phosphate
Submucosal Cryotherapy With Diclofenac SodiumExperimentalParticipants will receive standard local anesthesia followed by submucosal administration of cold normal saline (1 mL at 2-5°C) and diclofenac sodium (1 mL at 25 mg/mL) into the buccal vestibule adjacent to the affected maxillary molar before standardized single-visit root canal treatment. The interventions will be administered separately or sequentially according to the finalized study protocol.
Receives: Drug: Articaine Hydrochloride With Epinephrine; Procedure: Submucosal Cryotherapy; Drug: Diclofenac Sodium
Submucosal Cryotherapy With DexamethasoneExperimentalParticipants will receive standard local anesthesia followed by submucosal administration of cold normal saline (1 mL at 2-5°C) and dexamethasone sodium phosphate (1 mL at 4 mg/mL) into the buccal vestibule adjacent to the affected maxillary molar before standardized single-visit root canal treatment. The interventions will be administered separately or sequentially according to the finalized study protocol.
Receives: Drug: Articaine Hydrochloride With Epinephrine; Procedure: Submucosal Cryotherapy; Drug: Dexamethasone Sodium Phosphate

What is being measured

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

  1. Postoperative Pain Intensity Assessed Using the Numeric Rating Scale (NRS)

    Postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Participants will record their pain intensity at predefined postoperative intervals, and NRS scores will be compared among the six study groups.

    Measured: At 6, 12, 24, 48, and 72 hours after root canal treatment.

Secondary outcomes (3)
  1. Interleukin-6 (IL-6) Levels in Pulpal Blood

    Interleukin-6 (IL-6) levels will be measured in pulpal blood samples collected under aseptic conditions after access cavity opening during root canal treatment. Samples will be stored at -20°C and analyzed using enzyme-linked immunosorbent assay (ELISA). IL-6 levels will be compared among the six study groups to evaluate the local inflammatory response.

    Measured: During root canal treatment, immediately after access cavity opening (single intraoperative sample).

  2. Incidence of Postoperative Flare-Up

    The occurrence of postoperative flare-up following single-visit root canal treatment will be recorded. The number and percentage of participants experiencing flare-up will be determined and compared among the six study groups.

    Measured: Within 72 hours after root canal treatment.

  3. Incidence of Postoperative Rescue Analgesic Intake

    Participants will be instructed to avoid taking analgesics unless necessary. Any postoperative rescue analgesic intake will be recorded. The number and percentage of participants requiring rescue analgesics will be compared among the six study groups.

    Measured: Within 72 hours after root canal treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study start15 Nov 2026 (estimated)
  3. Primary completion15 Nov 2027 (estimated)
  4. Study completion15 Nov 2027 (estimated)

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This prospective, randomized, parallel-group clinical trial will include 90 patients with symptomatic irreversible pulpitis in maxillary molars. Participants will be randomly allocated in a 1:1:1:1:1:1 ratio to six groups (15 patients per group): anesthesia alone, anesthesia with submucosal cryotherapy, anesthesia with diclofenac sodium, anesthesia with dexamethasone, anesthesia with cryotherapy and diclofenac sodium, or anesthesia with cryotherapy and dexamethasone. All participants will undergo standardized single-visit root canal treatment.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07919938
Sponsor's protocol ID
1160/2026
Status last verified
Oct 2026
First submitted
31 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Articaine Hydrochloride With Epinephrine, Submucosal Cryotherapy and Diclofenac Sodium in people with Pulpitis, run by Suez Canal 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: opening soon, as of the sponsor's last update on 5 Nov 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hisham E El- Sayed, MSc (0 10 92192763 ext. +2, hesham_elsayed@dent.suez.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain Intensity Assessed Using the Numeric Rating Scale (NRS) (time frame: At 6, 12, 24, 48, and 72 hours after 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 5 Nov 2026.

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