Symptomatic Irreversible Pulpitis (SIP)Phase 4NCT07517367
Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisors
A Phase 4 study testing Cryotherapy in people with Symptomatic Irreversible Pulpitis (SIP), run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The aim is to compare the contributions of intraoral cryotherapy and supplemental lingual infiltration anesthesia to buccal infiltration anesthesia in mandibular incisor teeth with irreversible pulpitis in terms of anesthetic efficacy, and to evaluate the effect of adding intraoral cryotherapy to buccal anesthesia on… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis (SIP)
- What is being tested?
- Cryotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2025to 30 Aug 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 60 years
- Classified as ASA Physical Status I or II
- Presence of symptomatic irreversible pulpitis in a single-rooted mandibular incisor tooth
- Preoperative pain score ≥8 on the Numerical Rating Scale (NRS) and Wong-Baker FACES scale
- Positive response to cold test and electric pulp testing
- Absence of periapical pathology on preoperative periapical radiograph
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- No analgesic intake within 6 hours prior to treatment
- Ability to understand and complete pain assessment scales
- Willingness to provide written informed consent
Who cannot join
- Age below 18 years or above 60 years
- Pregnancy
- Known allergy to local anesthetic agents
- Diagnosis of diabetes mellitus
- Presence of hypothyroidism
- Diagnosis of adrenal insufficiency
Show all 13Show fewer
- Presence of Raynaud disease
- Uncontrolled diabetes (HbA1c >7%)
- Presence of periapical pathology detected radiographically
- Presence of sinus tract
- Presence of intraoral or extraoral swelling
- Teeth diagnosed with necrotic pulp
- Presence of referred pain from another tooth or anatomical structure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ondokuz Mayıs University
Samsun, Atakum
Cangül Keskin, PhD DDS, 03623121919 ext. 8254, cangul.keskin@omu.edu.tr
About this study
Official title: Evaluation of the Effect of Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisor Teeth With Irreversible Pulpitis
The aim is to compare the contributions of intraoral cryotherapy and supplemental lingual infiltration anesthesia to buccal infiltration anesthesia in mandibular incisor teeth with irreversible pulpitis in terms of anesthetic efficacy, and to evaluate the effect of adding intraoral cryotherapy to buccal anesthesia on anesthetic efficacy.
Read the detailed description
Achieving profound pulpal anesthesia in mandibular anterior teeth with symptomatic irreversible pulpitis remains a significant clinical challenge. Inflammation within the pulp tissue lowers the pain threshold and alters the local tissue environment, reducing the effectiveness of conventional local anesthetic techniques. Buccal infiltration anesthesia alone may be insufficient in mandibular incisors due to accessory innervation and anatomical variations, often necessitating supplemental techniques such as lingual infiltration or intraligamentary injections. However, repeated injections may increase patient discomfort and anxiety, highlighting the need for effective, non-pharmacological adjunctive methods to enhance anesthetic success.
Cryotherapy is a non-toxic, non-pharmacological method that has been widely used in medicine for its anti-inflammatory and analgesic effects. Local cold application induces vasoconstriction, reduces nerve conduction velocity, and limits inflammatory responses, thereby potentially enhancing anesthetic efficacy. Previous studies have demonstrated that intraoral cryotherapy can improve the success of inferior alveolar nerve block anesthesia in mandibular molars with irreversible pulpitis. However, there is currently no clinical evidence evaluating the effectiveness of intraoral cryotherapy in improving infiltration anesthesia success in mandibular incisor teeth diagnosed with irreversible pulpitis.The present randomized clinical study aims to compare the anesthetic efficacy of intraoral cryotherapy and supplemental lingual infiltration when used in conjunction with buccal infiltration anesthesia in mandibular incisors with symptomatic irreversible pulpitis. Additionally, the study evaluates whether intraoral cryotherapy can serve as an alternative to supplemental lingual infiltration for improving anesthetic success. The study also investigates the effect of vasoconstrictor-containing and vasoconstrictor-free local anesthetic solutions on anesthetic outcomes.
Eligible participants diagnosed with symptomatic irreversible pulpitis in mandibular central or lateral incisors are randomly assigned to one of seven experimental groups receiving different combinations of buccal infiltration, lingual infiltration, and intraoral cryotherapy, with or without vasoconstrictor-containing anesthetic solutions. Pain levels are assessed using a combination of Numerical Rating Scale (NRS) and Wong-Baker FACES scale during anesthetic administration and endodontic treatment procedures. Anesthetic success is determined based on patient-reported pain levels, electric pulp testing results, and the need for supplemental anesthesia. Additionally, thermal imaging is used to evaluate temperature changes in oral mucosa following anesthetic and cryotherapy applications, providing objective data on vasoconstriction and tissue response.
This study is expected to provide clinical evidence regarding the effectiveness of intraoral cryotherapy as an adjunctive method for improving anesthetic success in mandibular incisors with irreversible pulpitis. The findings may contribute to the development of safer, less invasive anesthetic protocols that improve patient comfort and reduce the need for multiple injections during endodontic emergency treatment.
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Being tested
- Cryotherapy
- Keywords
- Symptomatic Irreversible Pulpitis, Mandibular Incisor, Intraoral Cryotherapy, Buccal Infiltration Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
Intraoral cryotherapy will be applied using small ice packs wrapped in sterile gauze and placed into the vestibular sulcus adjacent to the target mandibular incisor. Participants will be instructed to maintain the ice pack in position for approximately 5 minutes prior to the anesthetic procedure. If discomfort occurs, participants will be allowed to briefly remove the ice pack and reapply it once comfort is restored. This intervention is intended to induce local vasoconstriction and reduce nerve conduction to enhance anesthetic efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Buccal Infiltration With Vasoconstrictor | No intervention | Participants will receive buccal infiltration anesthesia using 2.0 mL lidocaine with epinephrine administered to the vestibular sulcus of the target mandibular incisor. Anesthetic efficacy will be evaluated using electric pulp testing and patient-reported pain scores during endodontic treatment. |
| Buccal Infiltration Without Vasoconstrictor | No intervention | Participants will receive buccal infiltration anesthesia using 2.0 mL lidocaine without vasoconstrictor administered to the vestibular sulcus of the target mandibular incisor. Anesthetic success will be assessed using electric pulp testing and intraoperative pain scoring. |
| Buccal and Lingual Infiltration With Vasoconstrictor | No intervention | Participants will receive both buccal and lingual infiltration anesthesia using lidocaine with epinephrine administered to the vestibular and lingual aspects of the mandibular incisor. Anesthetic efficacy will be evaluated using electric pulp testing and patient-reported pain scores. |
| Buccal and Lingual Infiltration Without Vasoconstrictor | No intervention | Participants will receive buccal and lingual infiltration anesthesia using lidocaine without vasoconstrictor administered to the vestibular and lingual regions of the mandibular incisor. Pain response and anesthetic success will be recorded during treatment. |
| Buccal Infiltration With Vasoconstrictor and Cryotherapy | Experimental | Participants will receive intraoral cryotherapy applied to the vestibular sulcus for approximately 5 minutes followed by buccal infiltration anesthesia using lidocaine with epinephrine. Anesthetic success and pain response will be assessed during endodontic procedures. Receives: Other: Cryotherapy |
| Buccal Infiltration Without Vasoconstrictor and Cryotherapy | Experimental | Participants will receive intraoral cryotherapy applied to the vestibular sulcus for approximately 5 minutes followed by buccal infiltration anesthesia using lidocaine without vasoconstrictor. Pain levels and anesthetic success will be recorded. Receives: Other: Cryotherapy |
| Buccal and Lingual Infiltration With Cryotherapy | Experimental | Participants will receive intraoral cryotherapy followed by buccal and lingual infiltration anesthesia using lidocaine with epinephrine. Anesthetic efficacy will be evaluated using electric pulp testing and patient-reported pain scores during treatment. Receives: Other: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetic Success Rate During Endodontic Treatment
Anesthetic success will be defined as the absence of moderate or severe pain during pulpectomy procedures. Pain intensity will be assessed using Numerical Rating Scale (NRS). Anesthetic failure will be recorded if the participant reports moderate to severe pain, requires supplemental anesthesia, or shows positive response to electric pulp testing.
Measured: During pulpectomy procedure (up to 30 minutes after anesthesia)
Anesthetic success rate
Anesthetic success will be defined as the absence of moderate or severe pain during pulpectomy procedures. Pain intensity will be assessed using Wong-Baker FACES scale. Anesthetic failure will be recorded if the participant reports moderate to severe pain, requires supplemental anesthesia, or shows positive response to electric pulp testing.
Measured: During intervention
Secondary outcomes (2)
Intraoperative Pain During Pulpectomy
Pain intensity experienced during pulpectomy will be recorded using the Numerical Rating Scale (NRS) at any stage of treatment before pulp extirpation.
Measured: During pulpectomy procedure
Pain intensity during pulp extirpation
Pain intensity experienced during pulpectomy will be recorded using the Wong-Baker FACES scale at any stage of treatment before pulp extirpation.
Measured: During pulp extirpation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start31 Dec 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible Pulpitis (SIP)Studies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants diagnosed with symptomatic irreversible pulpitis in mandibular incisor teeth will be randomly assigned to one of seven parallel groups using a computer-generated randomization sequence. Each group will receive a different intervention protocol consisting of buccal infiltration anesthesia alone, buccal plus lingual infiltration anesthesia, or buccal infiltration combined with intraoral cryotherapy, with or without vasoconstrictor-containing local anesthetic solutions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cangül Keskin, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517367
- Sponsor's protocol ID
- 124R132
- Other IDs
- 124R132
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data sharing has not yet been determined. Data sharing policies will be evaluated after study completion in accordance with institutional regulations, ethical approvals, and applicable data protection laws.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisor Teeth With Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT07517367
- Acronym / sponsor ID
- 124R132
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Keywords
- Symptomatic Irreversible Pulpitis, Mandibular Incisor, Intraoral Cryotherapy, Buccal Infiltration Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 8 Apr 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.
The aim is to compare the contributions of intraoral cryotherapy and supplemental lingual infiltration anesthesia to buccal infiltration anesthesia in mandibular incisor teeth with irreversible pulpitis in terms of anesthetic efficacy, and to evaluate the effect of adding intraoral cryotherapy to buccal anesthesia on anesthetic efficacy.
Detailed description
Achieving profound pulpal anesthesia in mandibular anterior teeth with symptomatic irreversible pulpitis remains a significant clinical challenge. Inflammation within the pulp tissue lowers the pain threshold and alters the local tissue environment, reducing the effectiveness of conventional local anesthetic techniques. Buccal infiltration anesthesia alone may be insufficient in mandibular incisors due to accessory innervation and anatomical variations, often necessitating supplemental techniques such as lingual infiltration or intraligamentary injections. However, repeated injections may increase patient discomfort and anxiety, highlighting the need for effective, non-pharmacological adjunctive methods to enhance anesthetic success.
Cryotherapy is a non-toxic, non-pharmacological method that has been widely used in medicine for its anti-inflammatory and analgesic effects. Local cold application induces vasoconstriction, reduces nerve conduction velocity, and limits inflammatory responses, thereby potentially enhancing anesthetic efficacy. Previous studies have demonstrated that intraoral cryotherapy can improve the success of inferior alveolar nerve block anesthesia in mandibular molars with irreversible pulpitis. However, there is currently no clinical evidence evaluating the effectiveness of intraoral cryotherapy in improving infiltration anesthesia success in mandibular incisor teeth diagnosed with irreversible pulpitis.The present randomized clinical study aims to compare the anesthetic efficacy of intraoral cryotherapy and supplemental lingual infiltration when used in conjunction with buccal infiltration anesthesia in mandibular incisors with symptomatic irreversible pulpitis. Additionally, the study evaluates whether intraoral cryotherapy can serve as an alternative to supplemental lingual infiltration for improving anesthetic success. The study also investigates the effect of vasoconstrictor-containing and vasoconstrictor-free local anesthetic solutions on anesthetic outcomes.
Eligible participants diagnosed with symptomatic irreversible pulpitis in mandibular central or lateral incisors are randomly assigned to one of seven experimental groups receiving different combinations of buccal infiltration, lingual infiltration, and intraoral cryotherapy, with or without vasoconstrictor-containing anesthetic solutions. Pain levels are assessed using a combination of Numerical Rating Scale (NRS) and Wong-Baker FACES scale during anesthetic administration and endodontic treatment procedures. Anesthetic success is determined based on patient-reported pain levels, electric pulp testing results, and the need for supplemental anesthesia. Additionally, thermal imaging is used to evaluate temperature changes in oral mucosa following anesthetic and cryotherapy applications, providing objective data on vasoconstriction and tissue response.
This study is expected to provide clinical evidence regarding the effectiveness of intraoral cryotherapy as an adjunctive method for improving anesthetic success in mandibular incisors with irreversible pulpitis. The findings may contribute to the development of safer, less invasive anesthetic protocols that improve patient comfort and reduce the need for multiple injections during endodontic emergency treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 7
- Model description
- Participants diagnosed with symptomatic irreversible pulpitis in mandibular incisor teeth will be randomly assigned to one of seven parallel groups using a computer-generated randomization sequence. Each group will receive a different intervention protocol consisting of buccal infiltration anesthesia alone, buccal plus lingual infiltration anesthesia, or buccal infiltration combined with intraoral cryotherapy, with or without vasoconstrictor-containing local anesthetic solutions.
| Arm | Type | Receives |
|---|---|---|
| Buccal Infiltration With Vasoconstrictor | No intervention | –Participants will receive buccal infiltration anesthesia using 2.0 mL lidocaine with epinephrine administered to the vestibular sulcus of the target mandibular incisor. Anesthetic efficacy will be evaluated using electric pulp testing and patient-reported pain scores during endodontic treatment. |
| Buccal Infiltration Without Vasoconstrictor | No intervention | –Participants will receive buccal infiltration anesthesia using 2.0 mL lidocaine without vasoconstrictor administered to the vestibular sulcus of the target mandibular incisor. Anesthetic success will be assessed using electric pulp testing and intraoperative pain scoring. |
| Buccal and Lingual Infiltration With Vasoconstrictor | No intervention | –Participants will receive both buccal and lingual infiltration anesthesia using lidocaine with epinephrine administered to the vestibular and lingual aspects of the mandibular incisor. Anesthetic efficacy will be evaluated using electric pulp testing and patient-reported pain scores. |
| Buccal and Lingual Infiltration Without Vasoconstrictor | No intervention | –Participants will receive buccal and lingual infiltration anesthesia using lidocaine without vasoconstrictor administered to the vestibular and lingual regions of the mandibular incisor. Pain response and anesthetic success will be recorded during treatment. |
| Buccal Infiltration With Vasoconstrictor and Cryotherapy | Experimental | Other: CryotherapyParticipants will receive intraoral cryotherapy applied to the vestibular sulcus for approximately 5 minutes followed by buccal infiltration anesthesia using lidocaine with epinephrine. Anesthetic success and pain response will be assessed during endodontic procedures. |
| Buccal Infiltration Without Vasoconstrictor and Cryotherapy | Experimental | Other: CryotherapyParticipants will receive intraoral cryotherapy applied to the vestibular sulcus for approximately 5 minutes followed by buccal infiltration anesthesia using lidocaine without vasoconstrictor. Pain levels and anesthetic success will be recorded. |
| Buccal and Lingual Infiltration With Cryotherapy | Experimental | Other: CryotherapyParticipants will receive intraoral cryotherapy followed by buccal and lingual infiltration anesthesia using lidocaine with epinephrine. Anesthetic efficacy will be evaluated using electric pulp testing and patient-reported pain scores during treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adults aged 18 to 60 years
- Classified as ASA Physical Status I or II
- Presence of symptomatic irreversible pulpitis in a single-rooted mandibular incisor tooth
- Preoperative pain score ≥8 on the Numerical Rating Scale (NRS) and Wong-Baker FACES scale
- Positive response to cold test and electric pulp testing
Key exclusion criteria (13 listed)
- Age below 18 years or above 60 years
- Pregnancy
- Known allergy to local anesthetic agents
- Diagnosis of diabetes mellitus
- Presence of hypothyroidism
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 |
|---|---|---|
| CryotherapyIntraoral cryotherapy will be applied using small ice packs wrapped in sterile gauze and placed into the vestibular sulcus adjacent to the target mandibular incisor. Participants will be instructed to maintain the ice pack in position for approximately 5 minutes prior to the anesthetic procedure. If discomfort occurs, participants will be allowed to briefly remove the ice pack and reapply it once comfort is restored. This intervention is intended to induce local vasoconstriction and reduce nerve conduction to enhance anesthetic efficacy. | Other | Buccal Infiltration With Vasoconstrictor and Cryotherapy, Buccal Infiltration Without Vasoconstrictor and Cryotherapy, Buccal and Lingual Infiltration With Cryotherapy |
Primary outcome
Anesthetic Success Rate During Endodontic Treatment
Time frame: During pulpectomy procedure (up to 30 minutes after anesthesia)
Anesthetic success will be defined as the absence of moderate or severe pain during pulpectomy procedures. Pain intensity will be assessed using Numerical Rating Scale (NRS). Anesthetic failure will be recorded if the participant reports moderate to severe pain, requires supplemental anesthesia, or shows positive response to electric pulp testing.
Anesthetic success rate
Time frame: During intervention
Anesthetic success will be defined as the absence of moderate or severe pain during pulpectomy procedures. Pain intensity will be assessed using Wong-Baker FACES scale. Anesthetic failure will be recorded if the participant reports moderate to severe pain, requires supplemental anesthesia, or shows positive response to electric pulp testing.
2 secondary outcomes
Intraoperative Pain During Pulpectomy
Time frame: During pulpectomy procedure
Pain intensity during pulp extirpation
Time frame: During pulp extirpation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data sharing has not yet been determined. Data sharing policies will be evaluated after study completion in accordance with institutional regulations, ethical approvals, and applicable data protection laws.
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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.
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 Cryotherapy in people with Symptomatic Irreversible Pulpitis (SIP), run by Ondokuz Mayıs 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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 8 Apr 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cangül Keskin, PhD DDS (0905414203909, cangul.keskin@omu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthetic Success Rate During Endodontic Treatment (time frame: During pulpectomy procedure (up to 30 minutes after anesthesia)). The study lists 2 primary outcomes in all. 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 8 Apr 2026.