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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
98
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.
Ondokuz Mayıs University
Samsun, Atakum, Turkey (Türkiye)
RECRUITINGAnesthetic 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.
Time frame: 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.
Time frame: During intervention
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.
Time frame: 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.
Time frame: During pulp extirpation
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