Pulpitis - IrreversibleNCT06644703
Effect of Cryotherapy on Postoperative Pain in Vital Pulp Treatment of Molar Teeth
A study testing Cryotherapy in people with Pulpitis - Irreversible, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial was to evaluate the effect of cryotherapy with salin solution on the intensity of postoperative pain after total pulpotomy procedures in molar teeth with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Cryotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 30 Jul 2024
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Teeth with
- moderate or severe pain
- diagnosed with symptomatic irreversible pulpitis
- no tenderness to percussion and palpation
- positive response to cold test and electric pulp test
- no signs of periapical pathology
Who cannot join
- Teeth which
- could not be restored or required post-core
- had periapical lesions,
- had poor periodontal status (pocket depth> 4 mm),
- had negative responses to pulp sensitivity tests,
- had no pulp exposure after caries removing Patients who
Show all 9Show fewer
- had no preoperative pain or had mild preoperative pain
- had bleeding disorders
- had systemic diseases such as immunosuppressive disease or diabetes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çukurova Üniversitesi Diş Hekimliği Fakültesi, Gültepe, Sarıçam/Adana/Türkiye
Adana, 01250
About this study
Official title: Effect of Cryotherapy on Postoperative Pain in Vital Pulp Treatment of Molar Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
The goal of this clinical trial was to evaluate the effect of cryotherapy with salin solution on the intensity of postoperative pain after total pulpotomy procedures in molar teeth with symptomatic irreversible pulpitis. The main question it aims to answer is:
- Does controlled irrigation with cold saline in total pulpotomy reduce the severity of postoperative pain? In the cryotherapy group, unlike the control group, after hemostasis was achieved, the coronal pulp cavity was irrigated with 2 °C saline solution for 5 minutes.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Cryotherapy
- Keywords
- Cryotherapy, Vital pulp therapy, Irreversibl pulpitis, Postoperative pain, Total pulpotomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
The pulpotomy area was irrigated with 2 °C saline solution for 5 minutes in cryotherapy group.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy group | Experimental | After the coronal pulp tissue was completely removed up to the root canal orifice with a high-speed sterile diamond bur under water cooling, hemostasis was achieved within 8 minutes using a cotton pellet moistened with 1% NaOCl. The pulpotomy area was irrigated with 2 °C saline solution for 5 minutes. Then, the pulp chamber was covered with 2-3 mm thick Bio MTA+ (Cerkamed Company, Poland) and composite restoration of the teeth (Clearfil Majesty Posterior, Kuraray Medical Inc, Tokyo, Japan) was completed in the same visit. Receives: Other: Cryotherapy |
| Control group | No intervention | After the coronal pulp tissue was completely removed up to the root canal orifice with a high-speed sterile diamond bur under water cooling, hemostasis was achieved within 8 minutes using a cotton pellet moistened with 1% NaOCl. Then, the pulp chamber was covered with 2-3 mm thick Bio MTA+ (Cerkamed Company, Poland) and composite restoration of the teeth (Clearfil Majesty Posterior, Kuraray Medical Inc, Tokyo, Japan) was completed in the same visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Sep 2023
- Primary completion30 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Gürler, Cukurova University
- Investigators
- Hamdi Oğuz Yoldaş, DDS PHD, Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644703
- Sponsor's protocol ID
- 10.05.2025/144
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akhil VS, Kumar V, Aravind A, Sharma R, Sharma S, Chawla A, Upadhyay AD, Logani A. Novel cryotherapy technique for pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis- a randomized controlled trial. Clin Oral Investig. 2024 Apr 26;28(5):275. doi: 10.1007/s00784-024-05661-y.
PubMed 38668793Keskin C, Ozdemir O, Uzun I, Guler B. Effect of intracanal cryotherapy on pain after single-visit root canal treatment. Aust Endod J. 2017 Aug;43(2):83-88. doi: 10.1111/aej.12175. Epub 2016 Oct 4.
PubMed 27699913
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cryotherapy on Postoperative Pain in Vital Pulp Treatment of Molar Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06644703
- Acronym / sponsor ID
- 10.05.2025/144
- Conditions
- Pulpitis - Irreversible
- Keywords
- Cryotherapy, Vital pulp therapy, Irreversibl pulpitis, Postoperative pain, Total pulpotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 16 Oct 2024 (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.
The goal of this clinical trial was to evaluate the effect of cryotherapy with salin solution on the intensity of postoperative pain after total pulpotomy procedures in molar teeth with symptomatic irreversible pulpitis. The main question it aims to answer is:
- Does controlled irrigation with cold saline in total pulpotomy reduce the severity of postoperative pain? In the cryotherapy group, unlike the control group, after hemostasis was achieved, the coronal pulp cavity was irrigated with 2 °C saline solution for 5 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy group | Experimental | Other: CryotherapyAfter the coronal pulp tissue was completely removed up to the root canal orifice with a high-speed sterile diamond bur under water cooling, hemostasis was achieved within 8 minutes using a cotton pellet moistened with 1% NaOCl. The pulpotomy area was irrigated with 2 °C saline solution for 5 minutes. Then, the pulp chamber was covered with 2-3 mm thick Bio MTA+ (Cerkamed Company, Poland) and composite restoration of the teeth (Clearfil Majesty Posterior, Kuraray Medical Inc, Tokyo, Japan) was completed in the same visit. |
| Control group | No intervention | –After the coronal pulp tissue was completely removed up to the root canal orifice with a high-speed sterile diamond bur under water cooling, hemostasis was achieved within 8 minutes using a cotton pellet moistened with 1% NaOCl. Then, the pulp chamber was covered with 2-3 mm thick Bio MTA+ (Cerkamed Company, Poland) and composite restoration of the teeth (Clearfil Majesty Posterior, Kuraray Medical Inc, Tokyo, Japan) was completed in the same visit. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Teeth with
- moderate or severe pain
- diagnosed with symptomatic irreversible pulpitis
- no tenderness to percussion and palpation
- positive response to cold test and electric pulp test
Key exclusion criteria (9 listed)
- Teeth which
- could not be restored or required post-core
- had periapical lesions,
- had poor periodontal status (pocket depth> 4 mm),
- had negative responses to pulp sensitivity tests,
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 |
|---|---|---|
| CryotherapyThe pulpotomy area was irrigated with 2 °C saline solution for 5 minutes in cryotherapy group. | Other | Cryotherapy group |
Primary outcome
Visual Analogue Scale
Time frame: up to 72 hours
The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.
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 16 Oct 2024.
- Background: PubMed 38668793Akhil VS, Kumar V, Aravind A, Sharma R, Sharma S, Chawla A, Upadhyay AD, Logani A. Novel cryotherapy technique for pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis- a randomized controlled trial. Clin Oral Investig. 2024 Apr 26;28(5):275. doi: 10.1007/s00784-024-05661-y.
- Background: PubMed 27699913Keskin C, Ozdemir O, Uzun I, Guler B. Effect of intracanal cryotherapy on pain after single-visit root canal treatment. Aust Endod J. 2017 Aug;43(2):83-88. doi: 10.1111/aej.12175. Epub 2016 Oct 4.
- Individual participant dataSharing planned: No
Related trials for Pulpitis - Irreversible
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Recruiting
Effect of Menstrual Phase on the Anesthetic Efficacy
Pulpitis - Irreversible
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
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.
Hamdi Oğuz Yoldaş, DDS PHD study director
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with Pulpitis - Irreversible, run by Cukurova 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 6 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 16 Oct 2024. 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.
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?
Visual Analogue Scale (time frame: up to 72 hours). 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 NCT06644703, which also lists 2 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 16 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.