Actively Recruiting
Evaluation of the Effect of Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisor Teeth With Irreversible Pulpitis
Led by Ondokuz Mayıs University · Updated on 2026-04-08
98
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of intraoral cryotherapy compared to supplemental lingual infiltration anesthesia alongside buccal infiltration anesthesia in patients with symptomatic irreversible pulpitis affecting mandibular incisor teeth. This study aims to improve anesthetic success, as inflammation in these teeth often reduces the effectiveness of conventional anesthesia. The research also examines the impact of using anesthetic solutions with or without vasoconstrictors on pain control during treatment. Participants are randomly assigned to one of seven groups receiving various combinations of buccal infiltration, lingual infiltration, and intraoral cryotherapy, using lidocaine with or without vasoconstrictors. Intraoral cryotherapy involves applying cold packs to the vestibular sulcus for about five minutes before anesthesia. The trial compares these methods to assess which combination offers better pain relief and anesthetic success during endodontic procedures. During the study, participants will undergo electric pulp testing and report pain levels using the Numerical Rating Scale and Wong-Baker FACES scale throughout anesthesia administration and pulpectomy treatments lasting up to 30 minutes. Thermal imaging will monitor temperature changes in the oral tissues to better understand tissue responses. The primary outcome measures include anesthetic success rates during treatment, while secondary outcomes assess pain intensity during the procedures. This phase 4 study is expected to provide valuable insights into improving anesthesia for mandibular incisors with irreversible pulpitis.
CONDITIONS
Brief Title
Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 minutes
Participants receive intraoral cryotherapy followed by buccal and/or lingual infiltration anesthesia of the target mandibular incisor to evaluate anesthetic efficacy and pain levels during endodontic treatment.
1 treatment visit (in-person)
Trial Site Locations
Total: 1 location
1
Ondokuz Mayıs University
Samsun, Atakum, Turkey (Türkiye)
Actively Recruiting
Research Team
C
Cangül Keskin, PhD DDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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