This Clinical Trial Aims to Compare the Effectiveness of Two Intra-pulpal Cryotherapy Techniques-Endo-ice and Ice Sticks-in Decreasing Intra-operative Pain and Enhancing the Success of Local Anesthesia During Pulpectomy of Mandibular Molars With Symptomatic Irreversible Pulpitis.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorDow University of Health Sciences

About this trial

The goal of this clinical trail is to compare the analgesic effect of endo-ice and ice-sticks in reducing intra-operative pain during pulpectomy in molars with Symptomatic Irreversible Pulpitis. Principal Investigator will perform the procedure and outcome assessor will interview the participants as well as fill the pre-operative questionnaire. The patient will be instructed beforehand on how to score their pre-operative, intra-operative and post-operative intensity of pain according to Visual Analogue Scale.The Anxiety level of patient will also be recorded according to the Corah's Dental Anxiety Scale questionnaire and their level of anxiety before and after the intervention will be recorded by the outcome assessor.

The principal investigator will perform all endodontic procedures, with the outcome assessor blinded to the cryotherapy method. Prior to administering IANB, a topical anesthetic gel will be applied. A 27-gauge needle will deliver 1.8 ml of 2% lidocaine with 1:100,000 epinephrine at a rate of 1 ml/min. After a 5-minute wait, anesthesia effectiveness will be confirmed through electric pulp testing (EPT) on a neighboring tooth, with two consecutive negative responses confirming success. Once adequate anesthesia is confirmed, an access opening will be made under rubber dam isolation for the procedure.

1. CONTROL GROUP: After access opening and complete de-roofing of the pulp chamber, pulpectomy of the inflamed pulp will be performed under the given effective IANB with no additional intervention to control intra-operative pain. 2. ENDO-ICE GROUP: After access opening, pulp will be exposed and de-roofing will be performed. Endo-ice with the help of cotton pellet will be applied inside the pulp chamber for 2min (8 consecutive applications, 15sec each) and pulpectomy of the inflammed pulp will be performed immediately. 3. ICE-STICKS GROUP: Following the access opening and complete de-roofing of pulp chamber, four ice sticks will be placed inside the pulp chamber for 2 minutes (30 seconds each, using tweezer). Subsequently, pulpectomy of the inflamed pulp will be performed immediately.

Patients will be asked to rate their level of pain to the outcome assessor at four specific intervals during the trial, i.e., pre-operative (before local anesthesia), pre-operative (after local anesthesia), during pulpectomy and immediately after pulp extirpation and it will be recorded in a proforma by the blinded outcome assessor.

Pain and Anxiety Scores will be compared to asses either cryotherapy or which method of cryotherapy found to be effective in reducing intra-operative pain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals (Male and Female) aged 18 to 40 years.

Healthy individuals with no significant present and past medical findings.

Mandibular molars.

Symptomatic irreversible pulpitis (moderate to severe pain according to VAS 4-10).

Disqualifiers

Immature teeth with open apices.

Calcified pulp chamber and canals.

Periodontally compromised teeth.

Individuals who had taken steroids, analgesics, or antibiotics within the last 48 hours.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endo-ice (Refrigerant Spray)

    Other intervention

    Endo-ice (1,1, 1,2-Tetrafluoroethane, Refrigerant spray) have been most frequently used in dentistry to assess pulp sensibility. In this study, Endo-ice will be used to perform intra-coronal cryotherapy and its effectiveness in reducing intra-operative pain will be evaluated.

  • Ice-sticks

    Other intervention

    Ice-sticks have been mostly used in dentistry to assess pulp sensibility. In this study, Ice-sticks will be used to perform intra-coronal cryotherapy and it's effectiveness in reducing intra-operative pain will be evaluated.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Endo-ice GroupExperimental treatment 1 intervention
Group C: Ice-sticks GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Measuring Intra-operative pain using Visual Analogue Scale

Patient will be interviewed at different intervals during the procedure and pain scores will recorded with the help of Visual Analogue Scale. This scale usually features a 10 cm line from score 0 to 10 with well-defined boundaries, where 0 indicates No Pain and 7-10 indicates Severe Pain.

Time frame
3 hours

Secondary outcomes

1

Measuring Anxiety during procedure using Corah's Dental Anxiety Scale

Patient will be interviewed by the outcome assessor before and after the procedure and anxiety will be measured using Corah's Dental Anxiety Scale. It consists of four scenarios pertaining to dental treatment, each with five response options that reflects varying levels of anxiety. The total of these responses varies from 4 to 20, with scores above 12 indicate nervous patients and above 15 indicates phobic levels of anxiety.

Time frame
3 hours

Other outcomes

Sponsors and contacts

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