Symptomatic Irreversible PulpitisPhase 4NCT05424796
Postoperative Pain Intensity After Pulpotomy
A Phase 4 study testing Physiological saline, Hemostasis and cavity disinfection with NaOCl and Hemostasis and cavity disinfection with KTP laser in people with Symptomatic Irreversible Pulpitis, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: This study aimed to compare postoperative pain rates following sodium hypochlorite (NaOCl) and KTP laser-assisted pulpotomy treatments in permanent teeth with deep caries, and symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- Physiological saline, Hemostasis and cavity disinfection with NaOCl and Hemostasis and cavity disinfection with KTP laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2021to 11 Oct 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient should be ≥ 18 years old, a single tooth in every patient
- Must be signs of irreversible pulpitis, such as persistent pain that begins spontaneously and/or is exacerbated by cold. This situation should be repeated with the cold test.
- Irreversible pulpitis diagnosed, with or without symptomatic apical periodontitis
- No systemic disease
- Should give a positive response to electrical and thermal tests
- Must be the opposite tooth.
- The tooth is restorable, probing pocket (3mm) depth, and mobility are within normal limits
Who cannot join
- Presence of allergies
- Using analgesics in the last 12 hours or antibiotics in the last 1 week before the procedure.
- Presence of swelling, palpation pain or sinus tract before treatment, root fracture or crack.
- Failure to control bleeding within 6 minutes,
- Presence of bruxism or open apex.
- Insufficient bleeding after pulp exposure
- Observation of advanced canal calcification
- Presence of internal or external root resorption.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University
Sivas, Sivas/Merkez
About this study
Official title: Postoperative Pain Intensity Following Pulpotomy With Different Disinfection and Hemostatic Procedures in Teeth With Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial
Introduction: This study aimed to compare postoperative pain rates following sodium hypochlorite (NaOCl) and KTP laser-assisted pulpotomy treatments in permanent teeth with deep caries, and symptomatic irreversible pulpitis. Methods: Ninety patients complaining of permanent teeth pain due to symptomatic irreversible pulpitis were randomly divided into 3 equal groups. Preoperative pain levels were recorded. After the initial bleeding control was achieved with saline, complete hemostasis was achieved by applying saline (control group), 2.5% NaOCl, or KTP laser according to randomly determined patient groups. Patients were asked to mark their pain level on the visual pain scale at the 6th, 24th, 48th, and 72nd hours, and 7th and 30th days depending on the severity of the pain. The permanent restoration was completed after 7 days. Results: According to the present study, the statistical difference between the groups in terms of preoperative pain and percussion pain levels was insignificant.
There was no significant difference between the groups in terms of demographic data. The postoperative pain level of the KTP laser group was significantly lower at the 6th hour compared to the saline group. There was no significant difference between the groups in terms of postoperative pain level at other time intervals. The greatest pain scores occurred in all groups at 6th hour. Conclusions: KTP laser can be preferred primarily in reducing postoperative pain in pulpotomy treatments. KTP laser or NaOCl assisted pulpotomy can be an effective treatment for pain reduction in permanent teeth with symptomatic irreversible pulpitis.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Physiological saline, Hemostasis and cavity disinfection with NaOCl, Hemostasis and cavity disinfection with KTP laser
- Keywords
- Irreversible pulpitis, KTP laser, mineral trioxide aggregate, postoperative pain, pulpotomy, visual analog scale
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological salineCombination product
Pulpotomy is a vital pulp treatment in which the vital coronal pulp tissue is surgically removed and the remaining radicular dental pulp is covered with an appropriate material. In this group, hemostasis was achieved by checking the saline soaked cotton pellet.
Hemostasis and cavity disinfection with NaOClCombination product
Pulpotomy is a vital pulp treatment in which the vital coronal pulp tissue is surgically removed and the remaining radicular dental pulp is covered with an appropriate material. In this group, 2.5% NaOCl soaked cotton pellets were placed over canal orifices.
Hemostasis and cavity disinfection with KTP laserDevice
Pulpotomy is a vital pulp treatment in which the vital coronal pulp tissue is surgically removed and the remaining radicular dental pulp is covered with an appropriate material. In this group, complete hemostasis and cavity disinfection were achieved using a KTP laser (SMARLITE D, Deka, Calenzano FI, Italy).
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Physiological saline (Control group) (n=30) | Experimental | In this group, hemostasis was achieved by checking the saline soaked cotton pellet placed over canal orifices and into the pulp chamber at 2-minute intervals. Receives: Combination Product: Physiological saline |
| Group 2: Hemostasis and cavity disinfection with NaOCl (n=30) | Experimental | In this group, 2.5% NaOCl soaked cotton pellets were placed over canal orifices and into the pulp chamber to achieve complete hemostasis. Receives: Combination Product: Hemostasis and cavity disinfection with NaOCl |
| Group 3: Hemostasis and cavity disinfection with KTP laser (n=30) | Experimental | In this group, complete hemostasis and cavity disinfection were achieved using a KTP laser (SMARLITE D, Deka, Calenzano FI, Italy). After initial hemorrhage control, complete hemostasis was achieved by exposure to a KTP laser (532 nm wavelength) in noncontact mode at 1.5 W of power with a pulse mode (Ton 100 ms, Toff 100 ms) for 2 s. The diameter of optical fiber was 300 μm. Laser application was repeated 3 times if required. After bleeding control was achieved, cavity disinfection was performed by laser application with a noncontact circular movement for 5 s using 1 W power and 300 nm tip. Receives: Device: Hemostasis and cavity disinfection with KTP laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain intensity on the visual analog scale (VAS) at 6, 24, 48, and 72 hours, and 7 and 30 days after treatment.
The preoperative pain values of the patient were marked on the visual analog scale by the patient. The intensity of the pain was calculated by measuring the area in which the individual was marked between 0 (no pain) and 100 (worst pain). Patients recorded postoperative pain levels on the VAS for pain from 0 (no pain) to 100 (worst pain) at 6, 24, and 48 hours, and 7 and 30 days after treatment.
Measured: Baseline and at 6, 24, 48 and 72 hours, and 7 and 30 days after treatment.
Secondary outcomes (1)
Change from baseline in percussion values on the visual analog scale (VAS) at 7 and 30 days after treatment.
The preoperative percussion values of the patient were marked on the visual analog scale by the patient. The intensity of the percussion was calculated by measuring the area in which the individual was marked between 0 (no pain) and 100 (severe pain). Patients recorded postoperative percussion levels on the VAS for pain from 0 (no pain) to 100 (worst pain) at 7 and 30 days after treatment.
Measured: Baseline and at 7 and 30 days after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start15 Feb 2021
- Primary completion11 Oct 2021
- Study completion11 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Ayhan, Cumhuriyet University
- Investigators
- Demet Altunbaş, DDS, PhD, Study director, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424796
- Sponsor's protocol ID
- Cumhuriyet-University-M-AYHAN-
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ayhan M, Altunbas D. Efficacy of Potassium Titanyl Phosphate Laser and Sodium Hypochlorite on Postoperative Pain Intensity Following Pulpotomy in Teeth with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial. Photobiomodul Photomed Laser Surg. 2023 May;41(5):225-233. doi: 10.1089/photob.2022.0152. Epub 2023 Apr 24.
PubMed 37092958
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Intensity Following Pulpotomy With Different Disinfection and Hemostatic Procedures in Teeth With Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05424796
- Acronym / sponsor ID
- Cumhuriyet-University-M-AYHAN-
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- Irreversible pulpitis, KTP laser, mineral trioxide aggregate, postoperative pain, pulpotomy, visual analog scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 21 Jun 2022 (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: This study aimed to compare postoperative pain rates following sodium hypochlorite (NaOCl) and KTP laser-assisted pulpotomy treatments in permanent teeth with deep caries, and symptomatic irreversible pulpitis. Methods: Ninety patients complaining of permanent teeth pain due to symptomatic irreversible pulpitis were randomly divided into 3 equal groups. Preoperative pain levels were recorded. After the initial bleeding control was achieved with saline, complete hemostasis was achieved by applying saline (control group), 2.5% NaOCl, or KTP laser according to randomly determined patient groups. Patients were asked to mark their pain level on the visual pain scale at the 6th, 24th, 48th, and 72nd hours, and 7th and 30th days depending on the severity of the pain. The permanent restoration was completed after 7 days. Results: According to the present study, the statistical difference between the groups in terms of preoperative pain and percussion pain levels was insignificant.
There was no significant difference between the groups in terms of demographic data. The postoperative pain level of the KTP laser group was significantly lower at the 6th hour compared to the saline group. There was no significant difference between the groups in terms of postoperative pain level at other time intervals. The greatest pain scores occurred in all groups at 6th hour. Conclusions: KTP laser can be preferred primarily in reducing postoperative pain in pulpotomy treatments. KTP laser or NaOCl assisted pulpotomy can be an effective treatment for pain reduction in permanent teeth with symptomatic irreversible pulpitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Physiological saline (Control group) (n=30) | Experimental | Combination Product: Physiological salineIn this group, hemostasis was achieved by checking the saline soaked cotton pellet placed over canal orifices and into the pulp chamber at 2-minute intervals. |
| Group 2: Hemostasis and cavity disinfection with NaOCl (n=30) | Experimental | Combination Product: Hemostasis and cavity disinfection with NaOClIn this group, 2.5% NaOCl soaked cotton pellets were placed over canal orifices and into the pulp chamber to achieve complete hemostasis. |
| Group 3: Hemostasis and cavity disinfection with KTP laser (n=30) | Experimental | Device: Hemostasis and cavity disinfection with KTP laserIn this group, complete hemostasis and cavity disinfection were achieved using a KTP laser (SMARLITE D, Deka, Calenzano FI, Italy). After initial hemorrhage control, complete hemostasis was achieved by exposure to a KTP laser (532 nm wavelength) in noncontact mode at 1.5 W of power with a pulse mode (Ton 100 ms, Toff 100 ms) for 2 s. The diameter of optical fiber was 300 μm. Laser application was repeated 3 times if required. After bleeding control was achieved, cavity disinfection was performed by laser application with a noncontact circular movement for 5 s using 1 W power and 300 nm tip. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient should be ≥ 18 years old, a single tooth in every patient
- Must be signs of irreversible pulpitis, such as persistent pain that begins spontaneously and/or is exacerbated by cold. This situation should be repeated with the cold test.
- Irreversible pulpitis diagnosed, with or without symptomatic apical periodontitis
- No systemic disease
- Should give a positive response to electrical and thermal tests
Key exclusion criteria (8 listed)
- Presence of allergies
- Using analgesics in the last 12 hours or antibiotics in the last 1 week before the procedure.
- Presence of swelling, palpation pain or sinus tract before treatment, root fracture or crack.
- Failure to control bleeding within 6 minutes,
- Presence of bruxism or open apex.
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 |
|---|---|---|
| Physiological salinePulpotomy is a vital pulp treatment in which the vital coronal pulp tissue is surgically removed and the remaining radicular dental pulp is covered with an appropriate material. In this group, hemostasis was achieved by checking the saline soaked cotton pellet. | Combination product | Group 1: Physiological saline (Control group) (n=30) |
| Hemostasis and cavity disinfection with NaOClPulpotomy is a vital pulp treatment in which the vital coronal pulp tissue is surgically removed and the remaining radicular dental pulp is covered with an appropriate material. In this group, 2.5% NaOCl soaked cotton pellets were placed over canal orifices. | Combination product | Group 2: Hemostasis and cavity disinfection with NaOCl (n=30) |
| Hemostasis and cavity disinfection with KTP laserPulpotomy is a vital pulp treatment in which the vital coronal pulp tissue is surgically removed and the remaining radicular dental pulp is covered with an appropriate material. In this group, complete hemostasis and cavity disinfection were achieved using a KTP laser (SMARLITE D, Deka, Calenzano FI, Italy). | Device | Group 3: Hemostasis and cavity disinfection with KTP laser (n=30) |
Primary outcome
Change from baseline in pain intensity on the visual analog scale (VAS) at 6, 24, 48, and 72 hours, and 7 and 30 days after treatment.
Time frame: Baseline and at 6, 24, 48 and 72 hours, and 7 and 30 days after treatment.
The preoperative pain values of the patient were marked on the visual analog scale by the patient. The intensity of the pain was calculated by measuring the area in which the individual was marked between 0 (no pain) and 100 (worst pain). Patients recorded postoperative pain levels on the VAS for pain from 0 (no pain) to 100 (worst pain) at 6, 24, and 48 hours, and 7 and 30 days after treatment.
1 secondary outcome
Change from baseline in percussion values on the visual analog scale (VAS) at 7 and 30 days after treatment.
Time frame: Baseline and at 7 and 30 days after 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 28 Jun 2022.
- Derived from this study: PubMed 37092958Ayhan M, Altunbas D. Efficacy of Potassium Titanyl Phosphate Laser and Sodium Hypochlorite on Postoperative Pain Intensity Following Pulpotomy in Teeth with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial. Photobiomodul Photomed Laser Surg. 2023 May;41(5):225-233. doi: 10.1089/photob.2022.0152. Epub 2023 Apr 24.
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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.
Demet Altunbaş, DDS, PhD study director
Cumhuriyet University
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 Physiological saline, Hemostasis and cavity disinfection with NaOCl and Hemostasis and cavity disinfection with KTP laser in people with Symptomatic Irreversible Pulpitis, run by Cumhuriyet 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 7 inclusion and 8 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 28 Jun 2022. 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?
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?
Change from baseline in pain intensity on the visual analog scale (VAS) at 6, 24, 48, and 72 hours, and 7 and 30 days after treatment. (time frame: Baseline and at 6, 24, 48 and 72 hours, and 7 and 30 days after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05424796, which also lists 1 linked publication.
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 28 Jun 2022.