Symptomatic Irreversible PulpitisNCT07332936
Tobradex as Intracanal Medicament
A study testing Calcium Hydroxide (Ca(OH)2) and Tobramycin + Dexamethasone in people with Symptomatic Irreversible Pulpitis and Postoperative Endodontic Pain Following Emergency Root Canal Treatment, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
The goal of this prospective clinical study was to evaluate and compare the short-term effects of two intracanal medicaments-calcium hydroxide and a tobramycin-dexamethasone combination (Tobradex)-on postoperative pain following emergency root canal treatment in adult patients with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Irreversible Pulpitis, Postoperative Endodontic Pain Following Emergency Root Canal Treatment
- What is being tested?
- Calcium Hydroxide (Ca(OH)2) and Tobramycin + Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jul 2023to 30 Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Patients presenting with acute dental pain diagnosed as symptomatic irreversible pulpitis
- Teeth requiring emergency root canal treatment
- Ability to understand and provide informed consent
- Willingness to report pain levels during the follow-up period
Who cannot join
- Presence of acute or chronic apical abscess requiring systemic antibiotic therapy
- Teeth with previous root canal treatment
- Patients with systemic conditions that may affect healing or pain perception (e.g., uncontrolled diabetes, immunocompromised status)
- Known allergy or hypersensitivity to calcium hydroxide, tobramycin, dexamethasone, or related compounds
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Faculty of Dental Medicine, Umm Al-Qura University
Mecca
About this study
Official title: Effect of Calcium Hydroxide vs. Tobradex Intracanal Medicament on Postoperative Endodontic Pain: A Prospective Trial
The goal of this prospective clinical study was to evaluate and compare the short-term effects of two intracanal medicaments-calcium hydroxide and a tobramycin-dexamethasone combination (Tobradex)-on postoperative pain following emergency root canal treatment in adult patients with symptomatic irreversible pulpitis.
The main question it aimed to answer was:
Does Tobradex reduce postoperative endodontic pain more effectively than calcium hydroxide within the first 48 hours after emergency root canal treatment? Adult patients presenting with acute dental pain and already receiving emergency root canal therapy as part of their routine clinical care were included. After canal debridement, patients received either calcium hydroxide or Tobradex as an intracanal medicament based on availability at the time of treatment. Participants reported their pain intensity using a numeric rating scale before treatment and again at 24 and 48 hours following the procedure. Pain outcomes were compared between groups, and the influence of demographic factors such as age and gender was also explored.
Read the detailed description
This prospective clinical study investigates the effect of two commonly used intracanal medicaments-calcium hydroxide and a tobramycin-dexamethasone combination (Tobradex)-on postoperative pain following emergency root canal treatment. Postoperative pain remains a frequent concern after endodontic emergency procedures, particularly in teeth diagnosed with symptomatic irreversible pulpitis. While calcium hydroxide is widely used for its antimicrobial properties, evidence regarding its effectiveness in pain control is inconsistent. In contrast, intracanal medicaments containing corticosteroids have shown promise in reducing inflammation-related pain, yet limited clinical data are available for alternative steroid-antibiotic formulations such as Tobradex.
Patients presenting with acute endodontic pain and requiring emergency root canal treatment received standardized clinical care. Following canal debridement and irrigation, an intracanal medicament was placed, and the access cavity was temporized. The choice of medicament depended on availability during the emergency visit, reflecting real-world clinical practice. Pain intensity was assessed using a numeric rating scale at baseline and during the early postoperative period, allowing evaluation of both immediate and short-term pain reduction.
The primary focus of the study was to compare the magnitude and timing of pain relief achieved by the two medicaments within the first 48 hours after treatment. Secondary objectives included exploring whether patient-related factors, such as age or gender, influenced postoperative pain reduction. By examining pain outcomes during this critical early period, the study aims to clarify the potential benefit of incorporating a corticosteroid-antibiotic combination as an intracanal medicament in emergency endodontic care.
The findings of this study are intended to inform clinical decision-making regarding inter-appointment pain management and to provide preliminary evidence supporting alternative intracanal medicament strategies that prioritize patient comfort without compromising antimicrobial control.
- Conditions
- Symptomatic Irreversible Pulpitis, Postoperative Endodontic Pain Following Emergency Root Canal Treatment
- Being tested
- Calcium Hydroxide (Ca(OH)2), Tobramycin + Dexamethasone
- Keywords
- Intracanal medication, Calcium Hydroxide, Tobradex, Pain, Root canal treatment
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxide (Ca(OH)2)Drug
Calcium hydroxide is placed as an intracanal medicament after canal debridement during emergency root canal treatment as part of routine clinical practice.
Tobramycin + DexamethasoneDrug
Tobramycin-dexamethasone (Tobradex) is placed as an intracanal medicament after canal debridement during emergency root canal treatment to reduce postoperative inflammation and pain.
| Study group | Role | What they receive |
|---|---|---|
| Tobramycin-Dexamethasone (Tobradex) | Experimental | Participants receive a tobramycin-dexamethasone combination (Tobradex) as an intracanal medicament following standardized emergency root canal treatment for symptomatic irreversible pulpitis. Receives: Drug: Tobramycin + Dexamethasone |
| Calcium Hydroxide | Active comparator | Participants receive calcium hydroxide as an intracanal medicament following standardized emergency root canal treatment for symptomatic irreversible pulpitis. Receives: Drug: Calcium Hydroxide (Ca(OH)2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative endodontic pain intensity
Pain intensity measured using a numeric rating scale (0-10) at baseline, 24 hours, and 48 hours following intracanal medicament placement.
Measured: Baseline to 48 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jul 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulaziz Bakhsh, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332936
- Sponsor's protocol ID
- HAPO-02-K-012-2023-05-1631
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study will not be shared publicly. Aggregate, de-identified results will be reported through publications and presentations.
Publications
Alhilou AM, Al-Moraissi EA, Bakhsh A, Christidis N, Nasman P. Pain after emergency treatments of symptomatic irreversible pulpitis and symptomatic apical periodontitis in the permanent dentition: a systematic review of randomized clinical trials. Front Oral Health. 2023 Oct 18;4:1147884. doi: 10.3389/froh.2023.1147884. eCollection 2023.
PubMed 37920592Abduljabbar F, Othman SAA, Bakhsh A, Alhilou AM. Effect of calcium hydroxide vs. tobradex intracanal medicament on postoperative endodontic pain: a pragmatic prospective study. BMC Oral Health. 2026 Apr 8;26(1):970. doi: 10.1186/s12903-026-08286-7.
PubMed 41952147
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calcium Hydroxide vs. Tobradex Intracanal Medicament on Postoperative Endodontic Pain: A Prospective Trial
- ClinicalTrials.gov ID
- NCT07332936
- Acronym / sponsor ID
- HAPO-02-K-012-2023-05-1631
- Conditions
- Symptomatic Irreversible Pulpitis, Postoperative Endodontic Pain Following Emergency Root Canal Treatment
- Keywords
- Intracanal medication, Calcium Hydroxide, Tobradex, Pain, Root canal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 12 Jan 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 prospective clinical study was to evaluate and compare the short-term effects of two intracanal medicaments-calcium hydroxide and a tobramycin-dexamethasone combination (Tobradex)-on postoperative pain following emergency root canal treatment in adult patients with symptomatic irreversible pulpitis.
The main question it aimed to answer was:
Does Tobradex reduce postoperative endodontic pain more effectively than calcium hydroxide within the first 48 hours after emergency root canal treatment? Adult patients presenting with acute dental pain and already receiving emergency root canal therapy as part of their routine clinical care were included. After canal debridement, patients received either calcium hydroxide or Tobradex as an intracanal medicament based on availability at the time of treatment. Participants reported their pain intensity using a numeric rating scale before treatment and again at 24 and 48 hours following the procedure. Pain outcomes were compared between groups, and the influence of demographic factors such as age and gender was also explored.
Detailed description
This prospective clinical study investigates the effect of two commonly used intracanal medicaments-calcium hydroxide and a tobramycin-dexamethasone combination (Tobradex)-on postoperative pain following emergency root canal treatment. Postoperative pain remains a frequent concern after endodontic emergency procedures, particularly in teeth diagnosed with symptomatic irreversible pulpitis. While calcium hydroxide is widely used for its antimicrobial properties, evidence regarding its effectiveness in pain control is inconsistent. In contrast, intracanal medicaments containing corticosteroids have shown promise in reducing inflammation-related pain, yet limited clinical data are available for alternative steroid-antibiotic formulations such as Tobradex.
Patients presenting with acute endodontic pain and requiring emergency root canal treatment received standardized clinical care. Following canal debridement and irrigation, an intracanal medicament was placed, and the access cavity was temporized. The choice of medicament depended on availability during the emergency visit, reflecting real-world clinical practice. Pain intensity was assessed using a numeric rating scale at baseline and during the early postoperative period, allowing evaluation of both immediate and short-term pain reduction.
The primary focus of the study was to compare the magnitude and timing of pain relief achieved by the two medicaments within the first 48 hours after treatment. Secondary objectives included exploring whether patient-related factors, such as age or gender, influenced postoperative pain reduction. By examining pain outcomes during this critical early period, the study aims to clarify the potential benefit of incorporating a corticosteroid-antibiotic combination as an intracanal medicament in emergency endodontic care.
The findings of this study are intended to inform clinical decision-making regarding inter-appointment pain management and to provide preliminary evidence supporting alternative intracanal medicament strategies that prioritize patient comfort without compromising antimicrobial control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobramycin-Dexamethasone (Tobradex) | Experimental | Drug: Tobramycin + DexamethasoneParticipants receive a tobramycin-dexamethasone combination (Tobradex) as an intracanal medicament following standardized emergency root canal treatment for symptomatic irreversible pulpitis. |
| Calcium Hydroxide | Active comparator | Drug: Calcium Hydroxide (Ca(OH)2)Participants receive calcium hydroxide as an intracanal medicament following standardized emergency root canal treatment for symptomatic irreversible pulpitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older
- Patients presenting with acute dental pain diagnosed as symptomatic irreversible pulpitis
- Teeth requiring emergency root canal treatment
- Ability to understand and provide informed consent
- Willingness to report pain levels during the follow-up period
Key exclusion criteria (5 listed)
- Presence of acute or chronic apical abscess requiring systemic antibiotic therapy
- Teeth with previous root canal treatment
- Patients with systemic conditions that may affect healing or pain perception (e.g., uncontrolled diabetes, immunocompromised status)
- Known allergy or hypersensitivity to calcium hydroxide, tobramycin, dexamethasone, or related compounds
- Pregnant or lactating women
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 |
|---|---|---|
| Calcium Hydroxide (Ca(OH)2)Calcium hydroxide is placed as an intracanal medicament after canal debridement during emergency root canal treatment as part of routine clinical practice. | Drug | Calcium Hydroxide |
| Tobramycin + DexamethasoneTobramycin-dexamethasone (Tobradex) is placed as an intracanal medicament after canal debridement during emergency root canal treatment to reduce postoperative inflammation and pain. | Drug | Tobramycin-Dexamethasone (Tobradex) |
Primary outcome
Postoperative endodontic pain intensity
Time frame: Baseline to 48 hours post-treatment
Pain intensity measured using a numeric rating scale (0-10) at baseline, 24 hours, and 48 hours following intracanal medicament placement.
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 13 Jan 2026.
- Results publication: PubMed 37920592Alhilou AM, Al-Moraissi EA, Bakhsh A, Christidis N, Nasman P. Pain after emergency treatments of symptomatic irreversible pulpitis and symptomatic apical periodontitis in the permanent dentition: a systematic review of randomized clinical trials. Front Oral Health. 2023 Oct 18;4:1147884. doi: 10.3389/froh.2023.1147884. eCollection 2023.
- Derived from this study: PubMed 41952147Abduljabbar F, Othman SAA, Bakhsh A, Alhilou AM. Effect of calcium hydroxide vs. tobradex intracanal medicament on postoperative endodontic pain: a pragmatic prospective study. BMC Oral Health. 2026 Apr 8;26(1):970. doi: 10.1186/s12903-026-08286-7.
- Individual participant dataSharing planned: No. Individual participant data collected during this study will not be shared publicly. Aggregate, de-identified results will be reported through publications and presentations.
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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 study testing Calcium Hydroxide (Ca(OH)2) and Tobramycin + Dexamethasone in people with Symptomatic Irreversible Pulpitis and Postoperative Endodontic Pain Following Emergency Root Canal Treatment, run by Umm Al-Qura University at 1 site in Saudi Arabia.
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 5 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 13 Jan 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 Saudi Arabia. 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.
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?
Postoperative endodontic pain intensity (time frame: Baseline to 48 hours post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07332936, which also lists 2 linked publications.
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 13 Jan 2026.