Irreversible Pulpitis (Toothache)Phase 4NCT07506265
Comparative Evaluation of Intraligamentary Injection of Dexamethasone, Diclofenac Sodium, and Chymotrypsin for Enhancing the Success of 4% Articaine Buccal Infiltration in Mandibular Molars With Symptomatic Irreversible Pulpitis
A Phase 4 study testing Dexamathsone 4mg/ml associated with experimental arm, Diclofenac Sodium (DCS) and chymotrypsin in people with Irreversible Pulpitis (Toothache), run by Fayoum University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare anesthetic success rates of intraligamentary dexamethasone, diclofenac sodium, and chymotrypsin administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Irreversible Pulpitis (Toothache)
- What is being tested?
- Dexamathsone 4mg/ml associated with experimental arm, Diclofenac Sodium (DCS) and chymotrypsin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 23 May 2025to 1 Jan 2026
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Systemically healthy male patients (ASA I or II)
- Aged 18 to 50 years
- Presenting with symptomatic irreversible pulpitis in a restorable mandibular molar
- Preoperative moderate to severe pain (VAS ≥45 mm)
- Normal periapical tissue (no radiolucency, pocket depth ≤5 mm, mobility ≤ Grade I)
Who cannot join
- Medically compromised patients (ASA III or higher)
- History of allergy or intolerance to chymotrypsin, dexamethasone, diclofenac sodium, articaine.
- Vertical root fracture
- External or internal root resorption
- Periodontal pocket depth >5 mm
- Tooth mobility Grade II or III
- Presence of periapical lesion (radiolucency)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Intraligamentary Injection of Dexamethasone, Diclofenac Sodium, and Chymotrypsin for Enhancing the Success of 4% Articaine Buccal Infiltration in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
The goal of this clinical trial is to compare anesthetic success rates of intraligamentary dexamethasone, diclofenac sodium, and chymotrypsin administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis. Do these drugs lower the number of times participants need to be administrated with more local anesthesia? Researchers compared intraligamentary dexamethasone, diclofenac sodium, and chymotrypsin to a placebo (a look-alike substance that contains no drug) to see if interventional drugs work to achieve successful anesthesia.
- Participants were intraligamentary injected by drugs or a placebo once prior to buccal infiltration anesthesia
- Participants reported pain intensity using VAS at baseline (pre-injection), during access, and at 6, 24, 48 hours post-operative (patient diary / phone follow-up).
- Participants reported the onset time to subjective numbness (time from buccal infiltration to lip/tongue numbness).
- Conditions
- Irreversible Pulpitis (Toothache)
- Being tested
- Dexamathsone 4mg/ml associated with experimental arm, Diclofenac Sodium (DCS), chymotrypsin
- Keywords
- irreversible pulpitis, 4% articaine, buccal infiltration, dexamethasone, chymotrypsin, diclofenac sodium, mandibular molars, root canal
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamathsone 4mg/ml associated with experimental armDrug
intraligamentary dexamethasone administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis
Diclofenac Sodium (DCS)Drug
intraligamentary diclofenac sodium administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis
chymotrypsinDrug
intraligamentary chymotrypsin administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | intraligamentary saline administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis Receives: Drug: Dexamathsone 4mg/ml associated with experimental arm; Drug: Diclofenac Sodium (DCS); Drug: chymotrypsin |
| articaine | Active comparator | Not described Receives: Drug: Dexamathsone 4mg/ml associated with experimental arm; Drug: Diclofenac Sodium (DCS); Drug: chymotrypsin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetic success defined as no response to thermal test, electric pulp test and lip numbness and no pain (VAS ≤ 0 or no subjective pain/stimulation response) during endodontic access and initial instrumentation without need for additional anesthesia
Measured: from anesthsesia administartion till 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start23 May 2025
- Primary completion29 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible Pulpitis (Toothache)Studies of the same condition, open and under way.
- More trials run by Fayoum 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Nageh, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506265
- Sponsor's protocol ID
- RECO6U/34-2024
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 6 Apr 2026
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Intraligamentary Injection of Dexamethasone, Diclofenac Sodium, and Chymotrypsin for Enhancing the Success of 4% Articaine Buccal Infiltration in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07506265
- Acronym / sponsor ID
- RECO6U/34-2024
- Conditions
- Irreversible Pulpitis (Toothache)
- Keywords
- irreversible pulpitis, 4% articaine, buccal infiltration, dexamethasone, chymotrypsin, diclofenac sodium, mandibular molars, root canal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 23 May 2025 (actual)
- Primary completion
- 29 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 1 Apr 2026 (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 goal of this clinical trial is to compare anesthetic success rates of intraligamentary dexamethasone, diclofenac sodium, and chymotrypsin administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis. Do these drugs lower the number of times participants need to be administrated with more local anesthesia? Researchers compared intraligamentary dexamethasone, diclofenac sodium, and chymotrypsin to a placebo (a look-alike substance that contains no drug) to see if interventional drugs work to achieve successful anesthesia.
- Participants were intraligamentary injected by drugs or a placebo once prior to buccal infiltration anesthesia
- Participants reported pain intensity using VAS at baseline (pre-injection), during access, and at 6, 24, 48 hours post-operative (patient diary / phone follow-up).
- Participants reported the onset time to subjective numbness (time from buccal infiltration to lip/tongue numbness).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Dexamathsone 4mg/ml associated with experimental arm, Drug: Diclofenac Sodium (DCS), Drug: chymotrypsinintraligamentary saline administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis |
| articaine | Active comparator | Drug: Dexamathsone 4mg/ml associated with experimental arm, Drug: Diclofenac Sodium (DCS), Drug: chymotrypsin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Systemically healthy male patients (ASA I or II)
- Aged 18 to 50 years
- Presenting with symptomatic irreversible pulpitis in a restorable mandibular molar
- Preoperative moderate to severe pain (VAS ≥45 mm)
- Normal periapical tissue (no radiolucency, pocket depth ≤5 mm, mobility ≤ Grade I)
Key exclusion criteria (7 listed)
- Medically compromised patients (ASA III or higher)
- History of allergy or intolerance to chymotrypsin, dexamethasone, diclofenac sodium, articaine.
- Vertical root fracture
- External or internal root resorption
- Periodontal pocket depth >5 mm
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 |
|---|---|---|
| Dexamathsone 4mg/ml associated with experimental armintraligamentary dexamethasone administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis | Drug | articaine, placebo |
| Diclofenac Sodium (DCS)intraligamentary diclofenac sodium administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis | Drug | articaine, placebo |
| chymotrypsinintraligamentary chymotrypsin administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis | Drug | articaine, placebo |
Primary outcome
Anesthetic success defined as no response to thermal test, electric pulp test and lip numbness and no pain (VAS ≤ 0 or no subjective pain/stimulation response) during endodontic access and initial instrumentation without need for additional anesthesia
Time frame: from anesthsesia administartion till 48 hours postoperative
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 6 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 4 study testing Dexamathsone 4mg/ml associated with experimental arm, Diclofenac Sodium (DCS) and chymotrypsin in people with Irreversible Pulpitis (Toothache), run by Fayoum 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 5 inclusion and 7 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 6 Apr 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Anesthetic success defined as no response to thermal test, electric pulp test and lip numbness and no pain (VAS ≤ 0 or no subjective pain/stimulation response) during endodontic access and initial instrumentation without need for additional anesthesia (time frame: from anesthsesia administartion till 48 hours postoperative). 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 6 Apr 2026.