Health TrialsbyHealthPanel

Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisors

ConditionSymptomatic Irreversible Pulpitis (SIP)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorOndokuz Mayıs University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age below 18 years or above 60 years

Pregnancy

Known allergy to local anesthetic agents

Diagnosis of diabetes mellitus

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cryotherapy

    Other intervention

    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.

Treatment groups

98 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Buccal Infiltration With VasoconstrictorNo intervention 0 interventions
Group B: Buccal Infiltration Without VasoconstrictorNo intervention 0 interventions
Group C: Buccal and Lingual Infiltration With VasoconstrictorNo intervention 0 interventions
Group D: Buccal and Lingual Infiltration Without VasoconstrictorNo intervention 0 interventions
Group E: Buccal Infiltration With Vasoconstrictor and CryotherapyExperimental treatment 1 intervention
Group F: Buccal Infiltration Without Vasoconstrictor and CryotherapyExperimental treatment 1 intervention
Group G: Buccal and Lingual Infiltration With CryotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
During pulpectomy procedure (up to 30 minutes after anesthesia)
2

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

Secondary outcomes

1

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
2

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

Other outcomes

1

Need for Supplemental Anesthesia

The requirement for additional intraligamentary anesthesia during treatment will be recorded as an indicator of anesthetic failure.

Time frame
During pulpectomy procedure
2

Oral Mucosal Temperature Changes

Changes in oral mucosal surface temperature following anesthetic and/or cryotherapy application will be measured using thermal imaging. The lowest recorded temperature and duration of temperature change will be analyzed.

Time frame
From baseline to approximately 5 minutes after intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ondokuz Mayıs University

Lead sponsor

Source ClinicalTrials.gov
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