Cold therapy as an additional aid to numb lower teeth with anesthesia in patients undergoing Root Canal Treatment.

Not yet recruiting

Conditions: Pulpitis,

Registration Number: CTRI/2023/03/050746

Lead Sponsor: Dr Setu Katyal

Brief Summary: Effective pulpal anaesthesia is an important prerequisite for successful endodontic treatment. Inferior alveolar nerve block is one of the commonly employed techniques for anesthetising mandibular molars. Literature evidence shows the failure rate of IANB to be in the range of 19-56% especially in patients with symptomatic irreversible pulpitis1. In such situations, Inadequate pulpal anaesthesia may exacerbate the patientâ€™s fear and anxiety and extend treatment time, doubting the skill of the operator . A wide range of additional methods have been employed to improve the anaesthetic efficacy of IANB in symptomatic irreversible pulpitis but of these techniques were successful in producing complete pulpal analgesia required for endodontic treatment. So the search for a more efficient technique for intra operative pain management during endodontic treatment still continues. Cryoanalgesia has been successfully used in the field of medicine for managing both acute and chronic pain Cryotherapy also induces a local anaesthetic effect by lowering the activation threshold of nociceptors and the conduction velocity of pain signals. In light of the above mentioned statements, the objective of this study is to describe the temporary anaesthetic effect or Cryoanesthesia ensued by the application of cold spray (Endo Frost) along with ice application in pulp chamber and its effectiveness as a supplementary technique for inferior alveolar nerve block in patients diagnosed with symptomatic irreversible pulpitis undergoing root canal treatment. The null hypothesis tested will be that there will be no difference between the Control group (Patients administered Inferior Alveolar Nerve Block with 2% Lignocaine) and the Cryotherapy group (Patients administered with IANB with 2% Lignocaine supplemented with cold spray and ice application).

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Patients with fully formed root apex.
2.Patients with mandibular molars diagnosed with Symptomatic irreversible pulpitis.
3.Healthy patients without any significant medical disorders.
4.Patients with preoperative pain >54mm on a Heft-Parker visual analogue scale (0-170 mm).

Exclusion Criteria

1.Patients allergic to or hypersensitive to local anaesthetics.
2.Patients who took any analgesics or CNS depressants during 12 hours before the treatment.
3.Patients with any systemic diseases, mental disorders, pregnancy or lactation.
4.Patients with any facial paraesthesia or any pathosis on the site of injection 5.Patients with pathologic periodontal pockets during probing.
6.Teeth with fused roots or radiographic evidence of extra root.
7.Patients who refused to give their consent for the study.
8.Patients taking any medication that could interfere with anaesthesia For eg beta blockers or antidepressants.
9.Mandibular molars showed no response to cold test, exhibiting periradicular pathosis, internal or external root resorption or with non vital pulp at access opening 10.Patients who were alcoholic.
11.Patients with unsuccessful soft tissue anaesthesia after adminstaration of IANB 12.
Patients with positive response to electric pulp testing (done on maximal output at a gap of 2 minutes.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To analyze the pain score according to Heft Parker Visual analogue scale (0-170mm) and thus success of Inferior Alveolar Nerve Block with and without Cryotherapy during Root Canal Treatment in patients with Symptomatc Irreversible Pulpitis.	At the time of ongoing procedure

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): J.N Kapoor D.A.V Dental college, Yamunanagar, Haryana.
🇮🇳
Yamunanagar, HARYANA, India
J.N Kapoor D.A.V Dental college, Yamunanagar, Haryana.
🇮🇳Yamunanagar, HARYANA, India
Dr Setu Katyal
Principal investigator
7006465787
setukatyal94jk@gmail.com