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Tests treatment safety and results for Symptomatic Irreversible Pulpitis (SIP)
Official title Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisors
ClinicalTrials.gov ID: NCT07517367
What this study is testing
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- No analgesic intake within 6 hours prior to treatment
- Ability to understand and complete pain assessment scales
- Willingness to provide written informed consent
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Samsun, Atakum, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Samsun, Atakum, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.