Symptomatic Irreversible PulpitisPhase 2/3NCT05982392
Effect of Preoperative Tramadol and Naproxen Sodium on Post Operative Pain
A Phase 2/3 study testing Tramadol and Naproxen Sodium in people with Symptomatic Irreversible Pulpitis and Post Operative Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare in Tramadol, Naproxen sodium and Placebo in participants presenting with irreversible pulpitis in their mandibular molar teeth. The main question[s] it aims to answer are: Local anesthetic efficacy and . Postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis, Post Operative Pain
- What is being tested?
- Tramadol and Naproxen Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2023to 15 Aug 2023
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I and ASA II individuals who are between the ages of 18 and 60 years.
- Patients who have been diagnosed with symptomatic irreversible pulpitis (with either a normal periapex or symptomatic apical periodontitis).
- Patients who score moderate to severe (4-10) on a preoperative visual analogue scale (VAS= 1-10).
- Mandibular permanent molars.
Who cannot join
- Patients who had taken painkillers or narcotics in the previous 12 hours
- Patients suffering from severe pain because of traumatic occlusion.
- Teeth with extensive damage, calcified canals, root resorption, and an open apex.
- Previously root canal treated teeth.
- Medically compromised patients (ASA-III and above)
- Those with special communication needs or who do not understand Urdu or English language.
Show all 9Show fewer
- Pregnant and lactating women
- Individual patients who will be driving back alone
- Patients who are allergic to the prescribed medicines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Tramadol and Naproxen Sodium on Efficacy of Local Anesthesia and Post-operative Pain in Patients With Symptomatic Irreversible Pulpitis
The goal of this clinical trial is to compare in Tramadol, Naproxen sodium and Placebo in participants presenting with irreversible pulpitis in their mandibular molar teeth.
The main question[s] it aims to answer are:
- Local anesthetic efficacy and .
- Postoperative pain. Participants will receive premedication treatments 60 minutes prior to the local anesthesia administration.
Researchers will compare Tramadol, Naproxen sodium and Placebo to evaluate their effects on Inferior alveolar nerve block efficacy and Postoperative pain.
Read the detailed description
The adult participants who report in out-patient department (OPD) of Operative Dentistry at Dow International Dental College with the symptoms of irreversible pulpitis will be screened for the participation in the study. A detailed history will be taken which will be followed by clinical examination and complemented with sensibility testing with Endo Ice or electric pulp test. Radiographic analysis will also be done to confirm the diagnosis to assess for factors pertaining to exclusion and inclusion criteria. Verbal and written informed consent will be taken from all the participants.
Randomization: The participants will be randomly divided into 3 groups using a computer-generated randomization sequence (Microsoft Excel, Redmond, WA). The sequence was generated employing block randomization with an equal allocation ratio (1:1:1).
Group A will receive premedication of Oral tramadol 100mg, Group B will receive premedication of oral naproxen 550mg. Both medicines will be given 60 minutes prior to the local anesthesia administration. The third group, Group C, will be the control group and no active preoperative medication will be given to these participants. A placebo will be given to these participants. These medications will be given as a single intervention only.
Blinding: operator, participant and outcome assessor will be blinded. A paramedical staff will be trained in giving medication to the participants.
Pain scores will be recorded by asking the participant to rate their pain on a scale ranging from 0 to 10 before medication and then after 15 minutes, 30 minutes and 60 minutes of administering the premedication. Pain score will also be recorded after 10 minutes of the administration of Inferior alveolar nerve block (IANBs) and buccal nerve block \& during deroofing process of chamber opening. This step will serve as our primary outcome measure as anasthesia success rate.
Two cartridges of Lidocaine 1.8 ml having a concentration of 1:100,000 of Epinephrine will be used for administration of regional anesthesia. Access opening will be performed under rubber dam isolation with a round bur in a high-speed hand piece with copious water irrigation. Sodium hypochlorite (5.25%) will be used as a standard root canal irrigation solution.Pulpectomy will be performed with the Protaper universal file system until the working lengths of the teeth under study.
To assess the post-operative pain, a proforma and pain intensity scale will be provided to the participants for self recording at 6, 24, 48 and 72 hours after the procedure. The participants will return the proforma to an intern on 4th day to be assessed by an intern supervised by the principal investigator and assesed as secondary outcome of our study.
(For this research, "The investigators will be offering As per need analgesic for breakthrough pain. Participants will be offered brufen 400mg as needed. The participants will be advised to mark breakthrough pain on VAS at the time of taking medicine).
The participants will also be monitored for the adverse effects of these medications (nausea, vomiting, dizziness, drowsiness).
- Being tested
- Tramadol, Naproxen Sodium, Placebo
- Keywords
- Tramadol, Naproxen Sodium, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Also called Tramal tablet
Tramadol 100mg will be given 60 minutes before start of procedure.
Naproxen SodiumDrug
Also called Synflex 550mg
Naproxen sodium 550mg will be given 60 minutes before start of procedure.
PlaceboDrug
Also called Surbex Z
Placebo will be given 60 minutes before start of procedure.
| Study group | Role | What they receive |
|---|---|---|
| Tramadol | Active comparator | Group A will receive premedication of Oral tramadol 100mg, Receives: Drug: Tramadol |
| Naproxen Sodium | Active comparator | Group B will receive premedication of oral naproxen sodium 550mg. Receives: Drug: Naproxen Sodium |
| Placebo | Placebo comparator | Group C, will be the control group, and Surbex-Z will be given to these patients. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Local Anesthesia Efficacy
Local anesthesia efficacy was defined as absence of pain (VAS score ≤ 3) during access cavity preparation (deroofing) after inferior alveolar nerve block. Pain was assessed using a 10-point Visual Analog Scale (0 = no pain, 10 = worst pain). Participants were categorized as having successful anesthesia if VAS ≤ 3 and failure if VAS > 3.
Measured: During access cavity preparation (deroofing)
Secondary outcomes (1)
Postoperative Pain
Postoperative pain was assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores represent greater pain intensity. Pain scores were recorded at 6, 24, 48, and 72 hours postoperatively. Results are presented as median pain scores at each time point.
Measured: 6,24,48,72 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Mar 2023
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be randomly divided into 3 groups. Computer software (Microsoft Excel, Redmond, WA) will be used to generate a random patient allocation sequence. Group A will receive premedication of Oral tramadol 100mg, Group B will receive premedication of oral naproxen sodium 550mg. Both medicines will be given 60 minutes prior to the local anesthesia administration. The third group, Group C, will be the control group and no active preoperative medication will be given to these participants. A placebo will be given to these participants. These medications will be given as a single intervention only.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tayyaba Tahira, Dow University of Health Sciences
- Investigators
- Tayyaba Tahira, BDS FCPS, Principal investigator, Dow International Dental College, Dow University of Health SciencesFarah Naz, BDS FCPS, Study director, Dow International Dental College, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982392
- Sponsor's protocol ID
- 2889
- Status last verified
- Jun 2026
- First submitted
- 19 Jul 2023
- Last updated
- 25 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only investigators and co-investigators of this study will be able to access to participants' personal data. Ownership of the data will remain with the principal investigator and Department of Operative Dentistry, Dow International Dental College
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Tramadol and Naproxen Sodium on Efficacy of Local Anesthesia and Post-operative Pain in Patients With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT05982392
- Acronym / sponsor ID
- 2889
- Keywords
- Tramadol, Naproxen Sodium, Placebo
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Posted 25 Jun 2026
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 in Tramadol, Naproxen sodium and Placebo in participants presenting with irreversible pulpitis in their mandibular molar teeth.
The main question[s] it aims to answer are:
- Local anesthetic efficacy and .
- Postoperative pain. Participants will receive premedication treatments 60 minutes prior to the local anesthesia administration.
Researchers will compare Tramadol, Naproxen sodium and Placebo to evaluate their effects on Inferior alveolar nerve block efficacy and Postoperative pain.
Detailed description
The adult participants who report in out-patient department (OPD) of Operative Dentistry at Dow International Dental College with the symptoms of irreversible pulpitis will be screened for the participation in the study. A detailed history will be taken which will be followed by clinical examination and complemented with sensibility testing with Endo Ice or electric pulp test. Radiographic analysis will also be done to confirm the diagnosis to assess for factors pertaining to exclusion and inclusion criteria. Verbal and written informed consent will be taken from all the participants.
Randomization: The participants will be randomly divided into 3 groups using a computer-generated randomization sequence (Microsoft Excel, Redmond, WA). The sequence was generated employing block randomization with an equal allocation ratio (1:1:1).
Group A will receive premedication of Oral tramadol 100mg, Group B will receive premedication of oral naproxen 550mg. Both medicines will be given 60 minutes prior to the local anesthesia administration. The third group, Group C, will be the control group and no active preoperative medication will be given to these participants. A placebo will be given to these participants. These medications will be given as a single intervention only.
Blinding: operator, participant and outcome assessor will be blinded. A paramedical staff will be trained in giving medication to the participants.
Pain scores will be recorded by asking the participant to rate their pain on a scale ranging from 0 to 10 before medication and then after 15 minutes, 30 minutes and 60 minutes of administering the premedication. Pain score will also be recorded after 10 minutes of the administration of Inferior alveolar nerve block (IANBs) and buccal nerve block \& during deroofing process of chamber opening. This step will serve as our primary outcome measure as anasthesia success rate.
Two cartridges of Lidocaine 1.8 ml having a concentration of 1:100,000 of Epinephrine will be used for administration of regional anesthesia. Access opening will be performed under rubber dam isolation with a round bur in a high-speed hand piece with copious water irrigation. Sodium hypochlorite (5.25%) will be used as a standard root canal irrigation solution.Pulpectomy will be performed with the Protaper universal file system until the working lengths of the teeth under study.
To assess the post-operative pain, a proforma and pain intensity scale will be provided to the participants for self recording at 6, 24, 48 and 72 hours after the procedure. The participants will return the proforma to an intern on 4th day to be assessed by an intern supervised by the principal investigator and assesed as secondary outcome of our study.
(For this research, "The investigators will be offering As per need analgesic for breakthrough pain. Participants will be offered brufen 400mg as needed. The participants will be advised to mark breakthrough pain on VAS at the time of taking medicine).
The participants will also be monitored for the adverse effects of these medications (nausea, vomiting, dizziness, drowsiness).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- The participants will be randomly divided into 3 groups. Computer software (Microsoft Excel, Redmond, WA) will be used to generate a random patient allocation sequence. Group A will receive premedication of Oral tramadol 100mg, Group B will receive premedication of oral naproxen sodium 550mg. Both medicines will be given 60 minutes prior to the local anesthesia administration. The third group, Group C, will be the control group and no active preoperative medication will be given to these participants. A placebo will be given to these participants. These medications will be given as a single intervention only.
| Arm | Type | Receives |
|---|---|---|
| Tramadol | Active comparator | Drug: TramadolGroup A will receive premedication of Oral tramadol 100mg, |
| Naproxen Sodium | Active comparator | Drug: Naproxen SodiumGroup B will receive premedication of oral naproxen sodium 550mg. |
| Placebo | Placebo comparator | Drug: PlaceboGroup C, will be the control group, and Surbex-Z will be given to these patients. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA I and ASA II individuals who are between the ages of 18 and 60 years.
- Patients who have been diagnosed with symptomatic irreversible pulpitis (with either a normal periapex or symptomatic apical periodontitis).
- Patients who score moderate to severe (4-10) on a preoperative visual analogue scale (VAS= 1-10).
- Mandibular permanent molars.
Key exclusion criteria (9 listed)
- Patients who had taken painkillers or narcotics in the previous 12 hours
- Patients suffering from severe pain because of traumatic occlusion.
- Teeth with extensive damage, calcified canals, root resorption, and an open apex.
- Previously root canal treated teeth.
- Medically compromised patients (ASA-III and above)
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 |
|---|---|---|
| TramadolAlso: Tramal tabletTramadol 100mg will be given 60 minutes before start of procedure. | Drug | Tramadol |
| Naproxen SodiumAlso: Synflex 550mgNaproxen sodium 550mg will be given 60 minutes before start of procedure. | Drug | Naproxen Sodium |
| PlaceboAlso: Surbex ZPlacebo will be given 60 minutes before start of procedure. | Drug | Placebo |
Primary outcome
Number of Participants With Local Anesthesia Efficacy
Time frame: During access cavity preparation (deroofing)
Local anesthesia efficacy was defined as absence of pain (VAS score ≤ 3) during access cavity preparation (deroofing) after inferior alveolar nerve block. Pain was assessed using a 10-point Visual Analog Scale (0 = no pain, 10 = worst pain). Participants were categorized as having successful anesthesia if VAS ≤ 3 and failure if VAS > 3.
1 secondary outcome
Postoperative Pain
Time frame: 6,24,48,72 hours post operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Only investigators and co-investigators of this study will be able to access to participants' personal data. Ownership of the data will remain with the principal investigator and Department of Operative Dentistry, Dow International Dental College
Related trials for Symptomatic Irreversible Pulpitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
Recruiting
Effect of Menstrual Phase on the Anesthetic Efficacy
Pulpitis - Irreversible
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.
Tayyaba Tahira, BDS FCPS principal investigator
Dow International Dental College, Dow University of Health Sciences
Farah Naz, BDS FCPS study director
Dow International Dental College, Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tramadol and Naproxen Sodium in people with Symptomatic Irreversible Pulpitis and Post Operative Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
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 4 inclusion and 9 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 25 Jun 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 Pakistan. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Yes. Results are posted in the registry (first posted 25 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Local Anesthesia Efficacy (time frame: During access cavity preparation (deroofing)). 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 25 Jun 2026.