Reversible PulpitisEarly Phase 1NCT07114198
Pain Management in Teeth With Reversible Pulpitis
A Early Phase 1 study testing Ibuprofen 10 mg/kg in people with Reversible Pulpitis and Ibuprofen, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Effective intraoperative pain management is vital in paediatric dentistry, especially during vital pulp therapy (VPT) for reversible pulpitis. Although NSAIDs are widely used postoperatively, their role in controlling pain during treatment is less understood. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Reversible Pulpitis, Ibuprofen
- What is being tested?
- Ibuprofen 10 mg/kg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Aug 2025to 15 Aug 2025
- Phase
- Early Phase 1
- 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 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with no history of systemic disease,
- Demonstrated cooperative behaviour during treatment,
- Parental consent obtained for study participation,
- Presence of a first permanent mandibular molar with:
- Clinical and radiographic diagnosis of reversible pulpitis,
- Deep carious lesion extending beyond three-quarters of dentine thickness on periapical/bitewing radiographs (ICDAS score 5-6),
Show all 10Show fewer
- Positive cold test response with Endo-Ice (Hygienic Corp., Akron, OH, USA) producing short-lasting pain (subsiding within <10 seconds after stimulus removal),
- No clinical signs of swelling, abscess, or sinus tract,
- Absence of abnormal tooth mobility,
- Restorability of the tooth.
Who cannot join
- Presence of primary teeth requiring treatment,
- Clinical or radiographic diagnosis of irreversible pulpitis, necrotic pulp, apical lesion, swelling, abscess, or sinus tract,
- Analgesic intake within the preceding 12 hours,
- Known allergy to ibuprofen or local anaesthetics,
- Neurological or psychiatric developmental disorders,
- Presence of systemic illness,
- Existing gastrointestinal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Management in Teeth With Reversible Pulpitis: A Randomised Controlled Trial
Effective intraoperative pain management is vital in paediatric dentistry, especially during vital pulp therapy (VPT) for reversible pulpitis. Although NSAIDs are widely used postoperatively, their role in controlling pain during treatment is less understood. To investigate the effect of preoperative ibuprofen on pain perception and physiological stress during VPT in children.
Read the detailed description
This prospective, randomized, controlled clinical trial will investigate the effect of preoperative ibuprofen administration on intraoperative pain during vital pulp therapy (VPT) in pediatric patients diagnosed with reversible pulpitis. The study will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University. Ethical approval has been obtained from the Institutional Clinical Research Ethics Committee of Inonu University (Approval No: 2024-KAEK-08; Date: 25.12.2024). Written informed consent will be obtained from the parents of all participants.
A total of 44 children aged 7 to 13 years, in good general health, with deep carious lesions in a mandibular first permanent molar and a clinical diagnosis of reversible pulpitis will be included in the study. Participants will be randomly assigned in equal numbers (n=22 per group) to the intervention and control groups using a computer-generated randomization sequence and the sealed envelope method.
Children in the intervention group will receive oral ibuprofen (10 mg/kg) 40 minutes prior to treatment. The control group will receive no preoperative medication. A single-blind study design will be employed: the clinician performing the procedures will be aware of group allocation, while the statistician responsible for data analysis will remain blinded.
All participants will receive an inferior alveolar nerve block (IANB) before the procedure. Anesthesia will be verified with a cold test, and treatment will begin only after adequate anesthesia is confirmed. All procedures will be performed by the same pediatric dentist, following a standardized clinical protocol. The specific type of VPT (protective liner, direct pulp capping, partial pulpotomy, or coronal pulpotomy) will be selected based on clinical presentation.
Intraoperative pain will be assessed using both physiological and subjective measures. Pulse rate will be continuously monitored with a fingertip pulse oximeter, with a focus on readings taken when the bur approaches within close proximity to the pulp. Subjective pain will be measured using a Visual Analogue Scale (VAS), shown to the patient at the most sensitive moment of the procedure. Postoperative VAS scores will be recorded on Days 1, 3, and 7.
- Conditions
- Reversible Pulpitis, Ibuprofen
- Being tested
- Ibuprofen 10 mg/kg
- Keywords
- reversible pulpitis, ibuprofen, dental pain
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 10 mg/kgDrug
Ibuprofen was administered orally at a dose of 10 mg/kg body weight, 40 minutes before the start of the dental procedure. This intervention was designed to reduce intraoperative pain and pulse elevation associated with reversible pulpitis.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Children in this group received no preoperative medication before undergoing vital pulp therapy. Standard local anesthesia was administered prior to the procedure. |
| ibuprofen group | Experimental | Children in this group received a single dose of ibuprofen (10 mg/kg) orally, 40 minutes prior to vital pulp therapy. The goal was to evaluate the effect of preoperative ibuprofen on intraoperative pain and physiological stress. Receives: Drug: Ibuprofen 10 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity From Baseline (Pre-Operative) to Immediately During the Procedure (Day 0), Measured by the Visual Analogue Scale (VAS)
Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The change will be calculated as the score immediately during the procedure (Day 0) minus the Baseline (Pre-Operative) score. Higher scores indicate worse pain.
Measured: Pre-Operative (Baseline) and Immediately During the Procedure (Day 0)
Secondary outcomes (1)
Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 1, Measured by the Visual Analogue Scale (VAS)
Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The Baseline (Pre-Operative) VAS score will be compared with the VAS score reported by the participant on Day 1. On Day 1, participants will be contacted by phone and asked to rate their pain using the same VAS tool.
Measured: Pre-Operative (Baseline) and 1 days post-treatment (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start2 Aug 2025
- Primary completion11 Aug 2025
- Study completion15 Aug 2025
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Reversible 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Bilmez Selen, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114198
- Sponsor's protocol ID
- Ethics number:2024-KAEK-08
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2025
- Last updated
- 24 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I don't want it because the work hasn't been completed yet.
Publications
Carrasco-Labra A, Polk DE, Urquhart O, Aghaloo T, Claytor JW Jr, Dhar V, Dionne RA, Espinoza L, Gordon SM, Hersh EV, Law AS, Li BS, Schwartz PJ, Suda KJ, Turturro MA, Wright ML, Dawson T, Miroshnychenko A, Pahlke S, Pilcher L, Shirey M, Tampi M, Moore PA. Evidence-based clinical practice guideline for the pharmacologic management of acute dental pain in children: A report from the American Dental Association Science and Research Institute, the University of Pittsburgh School of Dental Medicine, and the Center for Integrative Global Oral Health at the University of Pennsylvania. J Am Dent Assoc. 2023 Sep;154(9):814-825.e2. doi: 10.1016/j.adaj.2023.06.014.
PubMed 37634915Shirvani A, Shamszadeh S, Eghbal MJ, Marvasti LA, Asgary S. Effect of preoperative oral analgesics on pulpal anesthesia in patients with irreversible pulpitis-a systematic review and meta-analysis. Clin Oral Investig. 2017 Jan;21(1):43-52. doi: 10.1007/s00784-016-1974-1. Epub 2016 Nov 11.
PubMed 27837343Pozzi A, Gallelli L. Pain management for dentists: the role of ibuprofen. Ann Stomatol (Roma). 2011 Jul;2(3-4 Suppl):3-24. Epub 2012 Apr 15. No abstract available.
PubMed 22888399Hargreaves K, Abbott PV. Drugs for pain management in dentistry. Aust Dent J. 2005 Dec;50(4 Suppl 2):S14-22. doi: 10.1111/j.1834-7819.2005.tb00378.x.
PubMed 16416713Bilmez Selen M, Kuru B. Effect of Preoperative Ibuprofen on Pain Perception and Pulse Rate in Paediatric Patients with Deep Caries: A Randomised Controlled Trial. Eur J Paediatr Dent. 2026 Apr 1:1. doi: 10.23804/ejpd.2026.2598. Online ahead of print.
PubMed 41972792
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management in Teeth With Reversible Pulpitis: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07114198
- Acronym / sponsor ID
- Ethics number:2024-KAEK-08
- Conditions
- Reversible Pulpitis, Ibuprofen
- Keywords
- reversible pulpitis, ibuprofen, dental pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 2 Aug 2025 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 11 Aug 2025 (actual)
- Results
- Posted 24 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effective intraoperative pain management is vital in paediatric dentistry, especially during vital pulp therapy (VPT) for reversible pulpitis. Although NSAIDs are widely used postoperatively, their role in controlling pain during treatment is less understood. To investigate the effect of preoperative ibuprofen on pain perception and physiological stress during VPT in children.
Detailed description
This prospective, randomized, controlled clinical trial will investigate the effect of preoperative ibuprofen administration on intraoperative pain during vital pulp therapy (VPT) in pediatric patients diagnosed with reversible pulpitis. The study will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University. Ethical approval has been obtained from the Institutional Clinical Research Ethics Committee of Inonu University (Approval No: 2024-KAEK-08; Date: 25.12.2024). Written informed consent will be obtained from the parents of all participants.
A total of 44 children aged 7 to 13 years, in good general health, with deep carious lesions in a mandibular first permanent molar and a clinical diagnosis of reversible pulpitis will be included in the study. Participants will be randomly assigned in equal numbers (n=22 per group) to the intervention and control groups using a computer-generated randomization sequence and the sealed envelope method.
Children in the intervention group will receive oral ibuprofen (10 mg/kg) 40 minutes prior to treatment. The control group will receive no preoperative medication. A single-blind study design will be employed: the clinician performing the procedures will be aware of group allocation, while the statistician responsible for data analysis will remain blinded.
All participants will receive an inferior alveolar nerve block (IANB) before the procedure. Anesthesia will be verified with a cold test, and treatment will begin only after adequate anesthesia is confirmed. All procedures will be performed by the same pediatric dentist, following a standardized clinical protocol. The specific type of VPT (protective liner, direct pulp capping, partial pulpotomy, or coronal pulpotomy) will be selected based on clinical presentation.
Intraoperative pain will be assessed using both physiological and subjective measures. Pulse rate will be continuously monitored with a fingertip pulse oximeter, with a focus on readings taken when the bur approaches within close proximity to the pulp. Subjective pain will be measured using a Visual Analogue Scale (VAS), shown to the patient at the most sensitive moment of the procedure. Postoperative VAS scores will be recorded on Days 1, 3, and 7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Children in this group received no preoperative medication before undergoing vital pulp therapy. Standard local anesthesia was administered prior to the procedure. |
| ibuprofen group | Experimental | Drug: Ibuprofen 10 mg/kgChildren in this group received a single dose of ibuprofen (10 mg/kg) orally, 40 minutes prior to vital pulp therapy. The goal was to evaluate the effect of preoperative ibuprofen on intraoperative pain and physiological stress. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Children with no history of systemic disease,
- Demonstrated cooperative behaviour during treatment,
- Parental consent obtained for study participation,
- Presence of a first permanent mandibular molar with:
Key exclusion criteria (7 listed)
- Presence of primary teeth requiring treatment,
- Clinical or radiographic diagnosis of irreversible pulpitis, necrotic pulp, apical lesion, swelling, abscess, or sinus tract,
- Analgesic intake within the preceding 12 hours,
- Known allergy to ibuprofen or local anaesthetics,
- Neurological or psychiatric developmental disorders,
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 |
|---|---|---|
| Ibuprofen 10 mg/kgIbuprofen was administered orally at a dose of 10 mg/kg body weight, 40 minutes before the start of the dental procedure. This intervention was designed to reduce intraoperative pain and pulse elevation associated with reversible pulpitis. | Drug | ibuprofen group |
Primary outcome
Change in Pain Intensity From Baseline (Pre-Operative) to Immediately During the Procedure (Day 0), Measured by the Visual Analogue Scale (VAS)
Time frame: Pre-Operative (Baseline) and Immediately During the Procedure (Day 0)
Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The change will be calculated as the score immediately during the procedure (Day 0) minus the Baseline (Pre-Operative) score. Higher scores indicate worse pain.
1 secondary outcome
Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 1, Measured by the Visual Analogue Scale (VAS)
Time frame: Pre-Operative (Baseline) and 1 days post-treatment (Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37634915Carrasco-Labra A, Polk DE, Urquhart O, Aghaloo T, Claytor JW Jr, Dhar V, Dionne RA, Espinoza L, Gordon SM, Hersh EV, Law AS, Li BS, Schwartz PJ, Suda KJ, Turturro MA, Wright ML, Dawson T, Miroshnychenko A, Pahlke S, Pilcher L, Shirey M, Tampi M, Moore PA. Evidence-based clinical practice guideline for the pharmacologic management of acute dental pain in children: A report from the American Dental Association Science and Research Institute, the University of Pittsburgh School of Dental Medicine, and the Center for Integrative Global Oral Health at the University of Pennsylvania. J Am Dent Assoc. 2023 Sep;154(9):814-825.e2. doi: 10.1016/j.adaj.2023.06.014.
- Results publication: PubMed 27837343Shirvani A, Shamszadeh S, Eghbal MJ, Marvasti LA, Asgary S. Effect of preoperative oral analgesics on pulpal anesthesia in patients with irreversible pulpitis-a systematic review and meta-analysis. Clin Oral Investig. 2017 Jan;21(1):43-52. doi: 10.1007/s00784-016-1974-1. Epub 2016 Nov 11.
- Results publication: PubMed 22888399Pozzi A, Gallelli L. Pain management for dentists: the role of ibuprofen. Ann Stomatol (Roma). 2011 Jul;2(3-4 Suppl):3-24. Epub 2012 Apr 15. No abstract available.
- Results publication: PubMed 16416713Hargreaves K, Abbott PV. Drugs for pain management in dentistry. Aust Dent J. 2005 Dec;50(4 Suppl 2):S14-22. doi: 10.1111/j.1834-7819.2005.tb00378.x.
- Derived from this study: PubMed 41972792Bilmez Selen M, Kuru B. Effect of Preoperative Ibuprofen on Pain Perception and Pulse Rate in Paediatric Patients with Deep Caries: A Randomised Controlled Trial. Eur J Paediatr Dent. 2026 Apr 1:1. doi: 10.23804/ejpd.2026.2598. Online ahead of print.
- ADA-Evidence-based clinical practice guideline for the pharmacologic management of acute dental pain in children.Link provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. I don't want it because the work hasn't been completed yet.
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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 Early Phase 1 study testing Ibuprofen 10 mg/kg in people with Reversible Pulpitis and Ibuprofen, run by Inonu University at 1 site in Turkey (Türkiye).
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 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 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 Turkey (Türkiye). 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 24 Sep 2025). 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?
Change in Pain Intensity From Baseline (Pre-Operative) to Immediately During the Procedure (Day 0), Measured by the Visual Analogue Scale (VAS) (time frame: Pre-Operative (Baseline) and Immediately During the Procedure (Day 0)). 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 NCT07114198, which also lists 5 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 24 Sep 2025.