Endodontic TreatmentPhase 4(DTPE-RCT)NCT06906315
Dexamethasone Treatment for Patients Undergoing Endodontics
A Phase 4 study testing Dexamethasone 4 mg and Ibuprofen group in people with Endodontic Treatment and Pulp Necrosis, run by University of Salamanca at 1 site in Spain.
Trial summary
This Phase IV randomized clinical trial (RCT) evaluated the efficacy of preoperative administration of a single 4 mg oral dose of dexamethasone in reducing postoperative pain and inflammation following endodontic treatment. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Endodontic Treatment, Pulp Necrosis, Periapical Lesions
- What is being tested?
- Dexamethasone 4 mg and Ibuprofen group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSpain
- Study dates
- 4 Nov 2024to 31 Jan 2025
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must meet all of the following criteria to be eligible for the study:
- Age Range: 20 to 50 years old.
- Indication for Endodontic Treatment: Patients requiring root canal therapy due to irreversible pulpitis (with or without apical lesion), pulp necrosis, retreatment with periapical lesion, or endodontic surgery.
- Eligible Teeth: Any dental group (anterior, premolar, molar, both maxillary and mandibular).
- General Health Status: Classified as ASA I (healthy individuals without systemic conditions) according to the American Society of Anesthesiologists (ASA) Physical Status Classification.
- Consent: Willingness to participate in the study and ability to provide signed informed consent.
Who cannot join
- Participants will be excluded if any of the following conditions apply:
- Age: Under 20 or over 50 years old.
- Medical Conditions:
- Immunocompromised individuals (e.g., HIV/AIDS, cancer patients undergoing chemotherapy).
- Systemic diseases such as diabetes mellitus, osteoporosis, acute psychosis, glaucoma, cataracts.
- Patients with tuberculosis or systemic fungal infections. Gastrointestinal conditions such as ulcerative colitis, peptic ulcers, or diverticulitis.
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- -Medication Use: Use of NSAIDs or corticosteroids within 48 hours prior to the intervention. Regular use of barbiturates.
- -Dental Factors: Tooth fractures involving the roots. Severe dental hypersensitivity that may interfere with pain assessment.
- -Pregnancy and Lactation: Pregnant or breastfeeding women will be excluded due to potential effects of dexamethasone.
- -Non-Compliance: Patients who decline participation or are unwilling to follow study procedures, including pain assessment and follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Management of Dexamethasone in Patients Undergoing Endodontics: Randomized Clinical Trial
This Phase IV randomized clinical trial (RCT) evaluated the efficacy of preoperative administration of a single 4 mg oral dose of dexamethasone in reducing postoperative pain and inflammation following endodontic treatment. Conducted at the Department of Endodontics, PhD Program, Faculty of Dentistry, University of Salamanca, the study included 82 participants who were randomly assigned to either the test group (preoperative dexamethasone) or the control group (postoperative ibuprofen 400 mg every 4 hours).
Pain intensity was measured using the Visual Analog Scale (VAS) at 4, 6, 8, 12, and 24 hours postoperatively. Results indicated significantly lower pain perception in the dexamethasone group compared to the ibuprofen group at all time points, with the majority of dexamethasone-treated patients reporting only mild pain. No adverse effects were observed in either group, and no patient required additional rescue analgesia.
Read more
The findings suggest that a single preoperative dose of dexamethasone is a safe and effective strategy for managing postoperative pain in endodontic procedures, providing superior analgesia compared to the standard postoperative ibuprofen regimen.
Keywords: Endodontic pain, dexamethasone, preoperative analgesia, randomized clinical trial, inflammation control, corticosteroids, endodontics.
Read the detailed description
Background and Rationale:
Endodontic treatment is a standard dental procedure aimed at preserving teeth with irreversible pulp damage or infection. A common complication following such procedures is postoperative pain and inflammation, typically managed with nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen. However, corticosteroids like dexamethasone, known for their potent anti-inflammatory and analgesic properties, may offer an alternative approach.
Dexamethasone is a long-acting glucocorticoid that inhibits phospholipase A2, thereby reducing the production of prostaglandins and leukotrienes-key mediators in the inflammatory cascade. This mechanism potentially prevents peripheral sensitization and hyperalgesia, which are central to post-endodontic pain. While dexamethasone has shown efficacy in oral surgery, its use as a preoperative analgesic in endodontics remains under-investigated.
Study Objectives:
The primary objective is to evaluate whether a single 4 mg oral dose of dexamethasone administered preoperatively reduces postoperative pain following endodontic treatment. Secondary objectives include assessing the need for rescue analgesia and monitoring for adverse effects.
Study Design:
This is a Phase IV randomized clinical trial using a parallel assignment model with a 1:1 allocation ratio. The study was conducted at the Faculty of Dentistry, University of Salamanca.
Participants and Randomization:
A total of 82 adult patients (aged 20-50) requiring endodontic intervention were enrolled. Participants were randomized into two groups:
Dexamethasone Group (Experimental): Received 4 mg dexamethasone orally 1 hour prior to the procedure.
Ibuprofen Group (Active Comparator): Received no preoperative medication but were prescribed 400 mg ibuprofen every 4 hours postoperatively.
Blinding:
The study was single-blind; participants were unaware of their group allocation.
Intervention:
All patients underwent standardized endodontic treatment involving local anesthesia, rubber dam isolation, mechanical root canal instrumentation using rotary systems, and irrigation with sodium hypochlorite. Root canal obturation followed standard protocols using gutta-percha and resin-based sealers.
Outcome Assessment:
Pain intensity will be measured using the Visual Analog Scale (VAS) at 4, 6, 8, 12, and 24 hours postoperatively. Secondary outcomes include the number of participants requiring rescue analgesia and any adverse effects reported during the first 24 hours.
Statistical Analysis:
Data will be analyzed using SPSS version 22.0. The normality of continuous variables will be assessed using the Shapiro-Wilk test. Pain intensity scores will be compared using ANOVA with Tukey post-hoc tests for multiple comparisons. A p-value < 0.05 will be considered statistically significant
- Being tested
- Dexamethasone 4 mg, Ibuprofen group
- Keywords
- Endodontic Pain Management, Dexamethasone, Postoperative Pain, Corticosteroids in Endodontics, Visual Analog Scale (VAS)
- Medical subject headings
- Dental Pulp Necrosis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 4 mgDrug
Participants in this group received a single 4 mg oral dose of dexamethasone 1 hour before undergoing endodontic treatment. No additional preoperative analgesics were administered. Standard endodontic procedures, including local anesthesia, were performed. Post-treatment, no routine analgesic medication was provided unless additional pain relief was required. Pain intensity was assessed at 4, 6, 8, 12, and 24 hours using the Visual Analog Scale (VAS) to evaluate the efficacy of preoperative dexamethasone in controlling postoperative pain and inflammation.
Ibuprofen groupDrug
Participants in this group received no preoperative medication but were prescribed 400 mg of ibuprofen every 4 hours postoperatively for pain management. The same standard endodontic procedures were performed. Pain levels were recorded at 4, 6, 8, 12, and 24 hours using the VAS scale to compare the effectiveness of postoperative ibuprofen with preoperative dexamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Group | Experimental | Participants in this group received a single 4 mg oral dose of dexamethasone 1 hour before undergoing endodontic treatment. No additional preoperative analgesics were administered. Standard endodontic procedures, including local anesthesia, were performed. Post-treatment, no routine analgesic medication was provided unless additional pain relief was required. Pain intensity was assessed at 4, 6, 8, 12, and 24 hours using the Visual Analog Scale (VAS) to evaluate the efficacy of preoperative dexamethasone in controlling postoperative pain and inflammation.
Arm 2 Receives: Drug: Dexamethasone 4 mg |
| Ibuprofen Group | Active comparator | Participants in this group received no preoperative medication but were prescribed 400 mg of ibuprofen every 4 hours postoperatively for pain management. The same standard endodontic procedures were performed. Pain levels were recorded at 4, 6, 8, 12, and 24 hours using the VAS scale to compare the effectiveness of postoperative ibuprofen with preoperative dexamethasone. Receives: Drug: Ibuprofen group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity (Visual Analog Scale Score)
Description: Pain intensity will be measured using the Visual Analog Scale (VAS), a 10-centimeter horizontal line where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will mark their perceived pain levels at each time point to assess postoperative discomfort following endodontic treatment.
Scale Range: 0 (no pain) to 10 (worst pain)
Interpretation: Higher scores indicate a worse outcome (greater pain intensity).
Measured: 4, 6, 8, 12, and 24 hours post-endodontic treatment
Secondary outcomes (1)
Need for Rescue Analgesia
Description: The number of participants requiring additional pain medication (rescue analgesia) beyond the assigned intervention will be recorded. This measure will help evaluate whether preoperative dexamethasone can reduce the necessity for additional analgesics compared to standard ibuprofen therapy.
Measured: 24 hours post-endodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start4 Nov 2024
- Primary completion27 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic TreatmentStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study follows a parallel assignment interventional model, where participants were randomly assigned to one of two groups: Dexamethasone Group: Received a single 4 mg oral dose of dexamethasone 1 hour before endodontic treatment. Ibuprofen Group: Received no preoperative medication but took 400 mg of ibuprofen every 4 hours postoperatively for pain management. Both groups underwent the same standardized endodontic procedure, ensuring that the only variable was the pain management intervention. This was a single-blind study where participants were blinded to treatment allocation. Randomization was performed in a 1:1 ratio using simple randomization. The primary outcome was postoperative pain intensity, measured using the VAS scale at 4, 6, 8, 12, and 24 hours. Secondary outcomes included rescue analgesia use and adverse effects.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heilyn Nils, University of Salamanca
- Investigators
- Javier Flores- Fraile Supervisor PI, PhD in Surgery and Dentistry, Study director, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906315
- Sponsor's protocol ID
- U1111-1320-4208
- Other IDs
- 2025_01/345
- Acronym
- (DTPE-RCT)
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study does not plan to share individual participant data (IPD) due to patient confidentiality and ethical considerations. Only aggregated, anonymized data will be presented in publications and reports.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Management of Dexamethasone in Patients Undergoing Endodontics: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06906315
- Acronym / sponsor ID
- (DTPE-RCT) / U1111-1320-4208
- Keywords
- Endodontic Pain Management, Dexamethasone, Postoperative Pain, Corticosteroids in Endodontics, Visual Analog Scale (VAS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 2 Apr 2025 (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.
This Phase IV randomized clinical trial (RCT) evaluated the efficacy of preoperative administration of a single 4 mg oral dose of dexamethasone in reducing postoperative pain and inflammation following endodontic treatment. Conducted at the Department of Endodontics, PhD Program, Faculty of Dentistry, University of Salamanca, the study included 82 participants who were randomly assigned to either the test group (preoperative dexamethasone) or the control group (postoperative ibuprofen 400 mg every 4 hours).
Pain intensity was measured using the Visual Analog Scale (VAS) at 4, 6, 8, 12, and 24 hours postoperatively. Results indicated significantly lower pain perception in the dexamethasone group compared to the ibuprofen group at all time points, with the majority of dexamethasone-treated patients reporting only mild pain. No adverse effects were observed in either group, and no patient required additional rescue analgesia.
The findings suggest that a single preoperative dose of dexamethasone is a safe and effective strategy for managing postoperative pain in endodontic procedures, providing superior analgesia compared to the standard postoperative ibuprofen regimen.
Keywords: Endodontic pain, dexamethasone, preoperative analgesia, randomized clinical trial, inflammation control, corticosteroids, endodontics.
Detailed description
Background and Rationale:
Endodontic treatment is a standard dental procedure aimed at preserving teeth with irreversible pulp damage or infection. A common complication following such procedures is postoperative pain and inflammation, typically managed with nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen. However, corticosteroids like dexamethasone, known for their potent anti-inflammatory and analgesic properties, may offer an alternative approach.
Dexamethasone is a long-acting glucocorticoid that inhibits phospholipase A2, thereby reducing the production of prostaglandins and leukotrienes-key mediators in the inflammatory cascade. This mechanism potentially prevents peripheral sensitization and hyperalgesia, which are central to post-endodontic pain. While dexamethasone has shown efficacy in oral surgery, its use as a preoperative analgesic in endodontics remains under-investigated.
Study Objectives:
The primary objective is to evaluate whether a single 4 mg oral dose of dexamethasone administered preoperatively reduces postoperative pain following endodontic treatment. Secondary objectives include assessing the need for rescue analgesia and monitoring for adverse effects.
Study Design:
This is a Phase IV randomized clinical trial using a parallel assignment model with a 1:1 allocation ratio. The study was conducted at the Faculty of Dentistry, University of Salamanca.
Participants and Randomization:
A total of 82 adult patients (aged 20-50) requiring endodontic intervention were enrolled. Participants were randomized into two groups:
Dexamethasone Group (Experimental): Received 4 mg dexamethasone orally 1 hour prior to the procedure.
Ibuprofen Group (Active Comparator): Received no preoperative medication but were prescribed 400 mg ibuprofen every 4 hours postoperatively.
Blinding:
The study was single-blind; participants were unaware of their group allocation.
Intervention:
All patients underwent standardized endodontic treatment involving local anesthesia, rubber dam isolation, mechanical root canal instrumentation using rotary systems, and irrigation with sodium hypochlorite. Root canal obturation followed standard protocols using gutta-percha and resin-based sealers.
Outcome Assessment:
Pain intensity will be measured using the Visual Analog Scale (VAS) at 4, 6, 8, 12, and 24 hours postoperatively. Secondary outcomes include the number of participants requiring rescue analgesia and any adverse effects reported during the first 24 hours.
Statistical Analysis:
Data will be analyzed using SPSS version 22.0. The normality of continuous variables will be assessed using the Shapiro-Wilk test. Pain intensity scores will be compared using ANOVA with Tukey post-hoc tests for multiple comparisons. A p-value < 0.05 will be considered statistically significant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study follows a parallel assignment interventional model, where participants were randomly assigned to one of two groups: Dexamethasone Group: Received a single 4 mg oral dose of dexamethasone 1 hour before endodontic treatment. Ibuprofen Group: Received no preoperative medication but took 400 mg of ibuprofen every 4 hours postoperatively for pain management. Both groups underwent the same standardized endodontic procedure, ensuring that the only variable was the pain management intervention. This was a single-blind study where participants were blinded to treatment allocation. Randomization was performed in a 1:1 ratio using simple randomization. The primary outcome was postoperative pain intensity, measured using the VAS scale at 4, 6, 8, 12, and 24 hours. Secondary outcomes included rescue analgesia use and adverse effects.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Group | Experimental | Drug: Dexamethasone 4 mgParticipants in this group received a single 4 mg oral dose of dexamethasone 1 hour before undergoing endodontic treatment. No additional preoperative analgesics were administered. Standard endodontic procedures, including local anesthesia, were performed. Post-treatment, no routine analgesic medication was provided unless additional pain relief was required. Pain intensity was assessed at 4, 6, 8, 12, and 24 hours using the Visual Analog Scale (VAS) to evaluate the efficacy of preoperative dexamethasone in controlling postoperative pain and inflammation. Arm 2 |
| Ibuprofen Group | Active comparator | Drug: Ibuprofen groupParticipants in this group received no preoperative medication but were prescribed 400 mg of ibuprofen every 4 hours postoperatively for pain management. The same standard endodontic procedures were performed. Pain levels were recorded at 4, 6, 8, 12, and 24 hours using the VAS scale to compare the effectiveness of postoperative ibuprofen with preoperative dexamethasone. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants must meet all of the following criteria to be eligible for the study:
- Age Range: 20 to 50 years old.
- Indication for Endodontic Treatment: Patients requiring root canal therapy due to irreversible pulpitis (with or without apical lesion), pulp necrosis, retreatment with periapical lesion, or endodontic surgery.
- Eligible Teeth: Any dental group (anterior, premolar, molar, both maxillary and mandibular).
- General Health Status: Classified as ASA I (healthy individuals without systemic conditions) according to the American Society of Anesthesiologists (ASA) Physical Status Classification.
Key exclusion criteria (10 listed)
- Participants will be excluded if any of the following conditions apply:
- Age: Under 20 or over 50 years old.
- Medical Conditions:
- Immunocompromised individuals (e.g., HIV/AIDS, cancer patients undergoing chemotherapy).
- Systemic diseases such as diabetes mellitus, osteoporosis, acute psychosis, glaucoma, cataracts.
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 |
|---|---|---|
| Dexamethasone 4 mgParticipants in this group received a single 4 mg oral dose of dexamethasone 1 hour before undergoing endodontic treatment. No additional preoperative analgesics were administered. Standard endodontic procedures, including local anesthesia, were performed. Post-treatment, no routine analgesic medication was provided unless additional pain relief was required. Pain intensity was assessed at 4, 6, 8, 12, and 24 hours using the Visual Analog Scale (VAS) to evaluate the efficacy of preoperative dexamethasone in controlling postoperative pain and inflammation. | Drug | Dexamethasone Group |
| Ibuprofen groupParticipants in this group received no preoperative medication but were prescribed 400 mg of ibuprofen every 4 hours postoperatively for pain management. The same standard endodontic procedures were performed. Pain levels were recorded at 4, 6, 8, 12, and 24 hours using the VAS scale to compare the effectiveness of postoperative ibuprofen with preoperative dexamethasone. | Drug | Ibuprofen Group |
Primary outcome
Postoperative Pain Intensity (Visual Analog Scale Score)
Time frame: 4, 6, 8, 12, and 24 hours post-endodontic treatment
Description: Pain intensity will be measured using the Visual Analog Scale (VAS), a 10-centimeter horizontal line where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will mark their perceived pain levels at each time point to assess postoperative discomfort following endodontic treatment. Scale Range: 0 (no pain) to 10 (worst pain) Interpretation: Higher scores indicate a worse outcome (greater pain intensity).
1 secondary outcome
Need for Rescue Analgesia
Time frame: 24 hours post-endodontic treatment
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 4 Apr 2025.
- Individual participant dataSharing planned: No. The study does not plan to share individual participant data (IPD) due to patient confidentiality and ethical considerations. Only aggregated, anonymized data will be presented in publications and reports.
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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.
Javier Flores- Fraile Supervisor PI, PhD in Surgery and Dentistry study director
University of Salamanca
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 Dexamethasone 4 mg and Ibuprofen group in people with Endodontic Treatment and Pulp Necrosis, run by University of Salamanca at 1 site in Spain.
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 6 inclusion and 10 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 4 Apr 2025. 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 Spain. 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 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?
Postoperative Pain Intensity (Visual Analog Scale Score) (time frame: 4, 6, 8, 12, and 24 hours post-endodontic 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 4 Apr 2025.