Pulpal ConditionNCT07618494
Elevation of Effect of Common Analgesic on Pulp Sensibility Tet
A study testing Paracetamol and Ibuprofen in people with Pulpal Condition, run by Pakistan Institute of Medical Sciences at 2 sites in Pakistan.
Trial summary
Introduction Pulp sensibility tests are essential in endodontic diagnosis because they help determine whether a tooth requires conservative management or irreversible treatment such as root canal therapy. Incorrect interpretation may result in unnecessary treatment or delayed management of irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Pulpal Condition
- What is being tested?
- Paracetamol and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Feb 2026to 5 May 2026
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 6.Sample selection:
- Healthy adults aged 18-40 years with intact, caries-free maxillary central incisors.
- Teeth showing normal baseline response to sensibility testing. No use of any analgesic, sedative, or psychotropic medication within the last 24 hours.
- Participants willing to comply with study procedures and follow-up schedule.
Who cannot join
- Teeth with restorations, fractures, attrition, or periapical pathology. Patients with systemic diseases influencing pain perception (e.g., diabetes, neuropathy).
- History of hypersensitivity or contraindication to the tested analgesics. Pregnant or lactating women. Participants with a history of long-term analgesic or corticosteroid use.
- -
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Ayesha Noor
Islamabad, Federal, 44000
School of dentistry
Islamabad, Federal, 44000
About this study
Official title: Elevation of Effect of Common Analgesic on Pulp Sensibility Test .:A Cilinical Trial
Introduction Pulp sensibility tests are essential in endodontic diagnosis because they help determine whether a tooth requires conservative management or irreversible treatment such as root canal therapy. Incorrect interpretation may result in unnecessary treatment or delayed management of irreversible pulpitis. These tests assess neural response indirectly rather than true pulpal blood supply, making them vulnerable to factors that alter pain perception.
Common analgesics such as NSAIDs, paracetamol, and opioids may influence pulpal sensibility test outcomes by modifying nociceptive pathways and pain thresholds. NSAIDs reduce prostaglandin synthesis and peripheral sensitization, whereas paracetamol and opioids act centrally to alter pain perception. Consequently, analgesic intake before testing may produce false-positive or false-negative responses, reducing diagnostic accuracy.
Read more
Rationale of the Study Patients frequently self-medicate with analgesics before dental consultation, which may interfere with pulpal sensibility testing. Despite the widespread clinical use of these tests, there is limited standardized evidence regarding the effect of commonly used analgesics on test responses. This study aims to clarify the influence of analgesics on pulpal sensibility tests and improve diagnostic reliability before irreversible endodontic procedures.
Hypothesis Pre-administration of common analgesics significantly alters pulpal sensibility test responses compared to an analgesic-free condition.
Objective To evaluate the effect of commonly used analgesics on diagnostic response patterns produced by standard pulpal sensibility tests.
Study Design and Methods Study Design: Randomized, double-blind, placebo-controlled clinical trial. Duration: 6 months after ethical approval. Sample Size: 184 participants. Sampling Technique: Non-probability consecutive sampling. Participants: Healthy adults aged 18-40 years with intact, caries-free maxillary central incisors showing normal baseline pulp responses.
Inclusion Criteria Healthy adults aged 18-40 years. Intact maxillary central incisors. Normal baseline pulp sensibility response. No recent use of analgesics or psychotropic drugs. Exclusion Criteria Restored or pathologic teeth. Systemic diseases affecting pain perception. Hypersensitivity to study drugs. Pregnant or lactating women. Long-term analgesic/corticosteroid users. Study Procedure
Participants will be randomly assigned into groups receiving:
Paracetamol 1000 mg Ibuprofen 400 mg Baseline pulp sensibility tests will be performed before drug administration and repeated one hour after administration, corresponding to peak plasma concentration.
Two diagnostic tests will be used:
Cold Test using refrigerant spray. Electric Pulp Test (EPT) using a digital pulp tester.
Primary outcome:
Change in EPT threshold values.
Secondary outcomes:
Changes in cold test response type and response time. Statistical Analysis Data will be analyzed using SPSS version 26.0. Descriptive statistics, Shapiro-Wilk test, paired t-test, one-way ANOVA with Tukey post hoc test, and chi-square test will be used. Statistical significance will be set at p < 0.05.
Read the detailed description
Detailed Description This study is designed to evaluate whether commonly used analgesic medications influence the results of pulpal sensibility tests, which are routinely used in endodontics to assess pulp vitality. Accurate diagnosis of pulpal status is essential because treatment decisions such as conservative monitoring or root canal therapy largely depend upon the interpretation of these tests. Since pulpal sensibility tests evaluate neural response rather than true pulpal blood circulation, their outcomes may be altered by medications that affect pain perception.
Common analgesics such as paracetamol and ibuprofen are frequently self-administered by patients before visiting the dentist. These drugs modify nociceptive pathways and may suppress or alter the patient's response to thermal or electrical stimulation during sensibility testing. Consequently, the clinician may obtain false-negative or delayed responses, increasing the risk of misdiagnosis and inappropriate treatment planning. Despite the widespread clinical use of these medications, there is insufficient standardized evidence regarding their effect on pulpal sensibility testing.
The present study will therefore investigate the effect of commonly used analgesics on the response patterns elicited by standard pulpal sensibility tests. The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial over a period of six months after ethical approval. A total of 184 healthy adult participants aged between 18 and 40 years will be included. Only subjects with intact, caries-free maxillary central incisors demonstrating normal baseline pulpal responses will be selected.
Participants will be randomly allocated into study groups using a computer-generated randomization sequence. Allocation concealment will be maintained through sealed opaque envelopes prepared by an independent researcher. Both the participants and the examiner conducting the pulp sensibility tests will remain blinded to group allocation in order to minimize bias. Identical placebo and drug capsules will be prepared by the institutional pharmacy department.
The study groups will receive commonly used analgesics including paracetamol 1000 mg and ibuprofen 400 mg orally with water under supervision. Baseline pulpal sensibility responses will first be recorded prior to drug administration. Post-drug testing will then be performed one hour after administration, corresponding to the expected peak plasma concentration of the drugs.
Two standardized pulp sensibility tests will be employed:
Cold test using refrigerant spray applied to the tooth surface. Electric pulp test (EPT) using a digital pulp tester. For the cold test, the participant will indicate the onset of sensation or pain, and the response will be categorized as positive, delayed, or absent. Response time will also be recorded using a digital stopwatch. For the electric pulp test, threshold values will be measured twice and averaged to reduce variability.
The primary outcome measure of the study will be the change in electric pulp test threshold values before and after analgesic administration. Secondary outcome measures will include alterations in cold test response type and response time.
Data analysis will be performed using SPSS version 26.0. Quantitative variables will be expressed as mean and standard deviation, whereas categorical variables will be reported as frequencies and percentages. Statistical tests including paired t-test, one-way ANOVA, Tukey post hoc test, chi-square test, and Shapiro-Wilk test will be applied where appropriate. A p-value of less than 0.05 will be considered statistically significant.
The findings of this study are expected to improve understanding regarding the pharmacological influence of analgesics on pulpal sensibility tests and help clinicians interpret diagnostic findings more accurately before making irreversible endodontic treatment decisions.
- Conditions
- Pulpal Condition
- Being tested
- Paracetamol, Ibuprofen
- Keywords
- Pulpal a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Oral paracetamol 1000mg administered before pulpal sensibility test
IbuprofenDrug
Oral Ibuprofen 400mg administered before pulpal sensibility testing.
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Experimental | Participants receive oral paracetamol 1000 mg before pulpal sensibility testing. Receives: Drug: Paracetamol |
| Ibuprofen | Experimental | Participants receive oral ibuprofen 400 mg before pulpal sensibility testing Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Electric Pulp Test (EPT) Threshold Values
Evaluation of changes in pulpal sensibility response thresholds after administration of paracetamol and ibuprofen.
Measured: Baseline and 1 hour after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Feb 2026
- Primary completion5 May 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpal ConditionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- this module to define the methods that will be used in this interventional study, including the strategy for assigning participants to intervention(s). * Required * § Required if Study Start Date is on or after January 18, 2017 \[\*\] Conditionally required Primary Purpose \* § Select the option that best describes the aim or goal of the study intervention(s). Diagnostic Study Phase \* Select one. Use "N/A" for trials that do not involve drug or biologic products. Interventional Study Model * Select - Model Description If needed, include additional details about the Interventional Study Model. 1,000 characters allowed Number of Arms \* § Enter the total number of arms participants might be assigned to over the course of the clinical study. Error: Required Field Masking \* § Select all roles that are masked, or select "None (Open Label)." Participant Care Provider Investigator Outcomes Assessor None (Open Label) Masking Description If there are other parties who are ma
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayesha Noor, Pakistan Institute of Medical Sciences
- Investigators
- Ayesha Noor, MDS tranii, Principal investigator, School of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618494
- Sponsor's protocol ID
- School of dentistry Pumps
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because its my personal
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevation of Effect of Common Analgesic on Pulp Sensibility Test .:A Cilinical Trial
- ClinicalTrials.gov ID
- NCT07618494
- Acronym / sponsor ID
- School of dentistry Pumps
- Conditions
- Pulpal Condition
- Keywords
- Pulpal a
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 1 Jun 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.
Introduction Pulp sensibility tests are essential in endodontic diagnosis because they help determine whether a tooth requires conservative management or irreversible treatment such as root canal therapy. Incorrect interpretation may result in unnecessary treatment or delayed management of irreversible pulpitis. These tests assess neural response indirectly rather than true pulpal blood supply, making them vulnerable to factors that alter pain perception.
Common analgesics such as NSAIDs, paracetamol, and opioids may influence pulpal sensibility test outcomes by modifying nociceptive pathways and pain thresholds. NSAIDs reduce prostaglandin synthesis and peripheral sensitization, whereas paracetamol and opioids act centrally to alter pain perception. Consequently, analgesic intake before testing may produce false-positive or false-negative responses, reducing diagnostic accuracy.
Rationale of the Study Patients frequently self-medicate with analgesics before dental consultation, which may interfere with pulpal sensibility testing. Despite the widespread clinical use of these tests, there is limited standardized evidence regarding the effect of commonly used analgesics on test responses. This study aims to clarify the influence of analgesics on pulpal sensibility tests and improve diagnostic reliability before irreversible endodontic procedures.
Hypothesis Pre-administration of common analgesics significantly alters pulpal sensibility test responses compared to an analgesic-free condition.
Objective To evaluate the effect of commonly used analgesics on diagnostic response patterns produced by standard pulpal sensibility tests.
Study Design and Methods Study Design: Randomized, double-blind, placebo-controlled clinical trial. Duration: 6 months after ethical approval. Sample Size: 184 participants. Sampling Technique: Non-probability consecutive sampling. Participants: Healthy adults aged 18-40 years with intact, caries-free maxillary central incisors showing normal baseline pulp responses.
Inclusion Criteria Healthy adults aged 18-40 years. Intact maxillary central incisors. Normal baseline pulp sensibility response. No recent use of analgesics or psychotropic drugs. Exclusion Criteria Restored or pathologic teeth. Systemic diseases affecting pain perception. Hypersensitivity to study drugs. Pregnant or lactating women. Long-term analgesic/corticosteroid users. Study Procedure
Participants will be randomly assigned into groups receiving:
Paracetamol 1000 mg Ibuprofen 400 mg Baseline pulp sensibility tests will be performed before drug administration and repeated one hour after administration, corresponding to peak plasma concentration.
Two diagnostic tests will be used:
Cold Test using refrigerant spray. Electric Pulp Test (EPT) using a digital pulp tester.
Primary outcome:
Change in EPT threshold values.
Secondary outcomes:
Changes in cold test response type and response time. Statistical Analysis Data will be analyzed using SPSS version 26.0. Descriptive statistics, Shapiro-Wilk test, paired t-test, one-way ANOVA with Tukey post hoc test, and chi-square test will be used. Statistical significance will be set at p < 0.05.
Detailed description
Detailed Description This study is designed to evaluate whether commonly used analgesic medications influence the results of pulpal sensibility tests, which are routinely used in endodontics to assess pulp vitality. Accurate diagnosis of pulpal status is essential because treatment decisions such as conservative monitoring or root canal therapy largely depend upon the interpretation of these tests. Since pulpal sensibility tests evaluate neural response rather than true pulpal blood circulation, their outcomes may be altered by medications that affect pain perception.
Common analgesics such as paracetamol and ibuprofen are frequently self-administered by patients before visiting the dentist. These drugs modify nociceptive pathways and may suppress or alter the patient's response to thermal or electrical stimulation during sensibility testing. Consequently, the clinician may obtain false-negative or delayed responses, increasing the risk of misdiagnosis and inappropriate treatment planning. Despite the widespread clinical use of these medications, there is insufficient standardized evidence regarding their effect on pulpal sensibility testing.
The present study will therefore investigate the effect of commonly used analgesics on the response patterns elicited by standard pulpal sensibility tests. The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial over a period of six months after ethical approval. A total of 184 healthy adult participants aged between 18 and 40 years will be included. Only subjects with intact, caries-free maxillary central incisors demonstrating normal baseline pulpal responses will be selected.
Participants will be randomly allocated into study groups using a computer-generated randomization sequence. Allocation concealment will be maintained through sealed opaque envelopes prepared by an independent researcher. Both the participants and the examiner conducting the pulp sensibility tests will remain blinded to group allocation in order to minimize bias. Identical placebo and drug capsules will be prepared by the institutional pharmacy department.
The study groups will receive commonly used analgesics including paracetamol 1000 mg and ibuprofen 400 mg orally with water under supervision. Baseline pulpal sensibility responses will first be recorded prior to drug administration. Post-drug testing will then be performed one hour after administration, corresponding to the expected peak plasma concentration of the drugs.
Two standardized pulp sensibility tests will be employed:
Cold test using refrigerant spray applied to the tooth surface. Electric pulp test (EPT) using a digital pulp tester. For the cold test, the participant will indicate the onset of sensation or pain, and the response will be categorized as positive, delayed, or absent. Response time will also be recorded using a digital stopwatch. For the electric pulp test, threshold values will be measured twice and averaged to reduce variability.
The primary outcome measure of the study will be the change in electric pulp test threshold values before and after analgesic administration. Secondary outcome measures will include alterations in cold test response type and response time.
Data analysis will be performed using SPSS version 26.0. Quantitative variables will be expressed as mean and standard deviation, whereas categorical variables will be reported as frequencies and percentages. Statistical tests including paired t-test, one-way ANOVA, Tukey post hoc test, chi-square test, and Shapiro-Wilk test will be applied where appropriate. A p-value of less than 0.05 will be considered statistically significant.
The findings of this study are expected to improve understanding regarding the pharmacological influence of analgesics on pulpal sensibility tests and help clinicians interpret diagnostic findings more accurately before making irreversible endodontic treatment decisions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- this module to define the methods that will be used in this interventional study, including the strategy for assigning participants to intervention(s). * Required * § Required if Study Start Date is on or after January 18, 2017 [*] Conditionally required Primary Purpose * § Select the option that best describes the aim or goal of the study intervention(s). Diagnostic Study Phase * Select one. Use "N/A" for trials that do not involve drug or biologic products. Interventional Study Model * Select - Model Description If needed, include additional details about the Interventional Study Model. 1,000 characters allowed Number of Arms * § Enter the total number of arms participants might be assigned to over the course of the clinical study. Error: Required Field Masking * § Select all roles that are masked, or select "None (Open Label)." Participant Care Provider Investigator Outcomes Assessor None (Open Label) Masking Description If there are other parties who are ma
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Experimental | Drug: ParacetamolParticipants receive oral paracetamol 1000 mg before pulpal sensibility testing. |
| Ibuprofen | Experimental | Drug: IbuprofenParticipants receive oral ibuprofen 400 mg before pulpal sensibility testing |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 6.Sample selection:
- Healthy adults aged 18-40 years with intact, caries-free maxillary central incisors.
- Teeth showing normal baseline response to sensibility testing. No use of any analgesic, sedative, or psychotropic medication within the last 24 hours.
- Participants willing to comply with study procedures and follow-up schedule.
Key exclusion criteria (3 listed)
- Teeth with restorations, fractures, attrition, or periapical pathology. Patients with systemic diseases influencing pain perception (e.g., diabetes, neuropathy).
- History of hypersensitivity or contraindication to the tested analgesics. Pregnant or lactating women. Participants with a history of long-term analgesic or corticosteroid use.
- -
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 |
|---|---|---|
| ParacetamolOral paracetamol 1000mg administered before pulpal sensibility test | Drug | Paracetamol |
| IbuprofenOral Ibuprofen 400mg administered before pulpal sensibility testing. | Drug | Ibuprofen |
Primary outcome
Change in Electric Pulp Test (EPT) Threshold Values
Time frame: Baseline and 1 hour after drug administration
Evaluation of changes in pulpal sensibility response thresholds after administration of paracetamol and ibuprofen.
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 1 Jun 2026.
- Individual participant dataSharing planned: No. Because its my personal
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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.
Ayesha Noor, MDS tranii principal investigator
School of dentistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol and Ibuprofen in people with Pulpal Condition, run by Pakistan Institute of Medical Sciences at 2 sites 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 3 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 1 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 2 sites 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. 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?
Change in Electric Pulp Test (EPT) Threshold Values (time frame: Baseline and 1 hour after drug administration). 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 1 Jun 2026.