Effect of Cold Local Anaesthesia for Root Canal Treatment

Phase 3

Not yet recruiting

Conditions: Dental caries, unspecified,

Registration Number: CTRI/2022/07/044387

Lead Sponsor: SRM Dental College

Brief Summary: | |

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|Inferior alveolar nerve block (IANB) using 2% lignocaine hydrochloride (HCl) with adrenaline in 1:100,000 (LA) concentration is considered to be one of the standard anaesthetic techniques for achieving pulpal anaesthesia for management of symptomatic irreversible pulpitis (SIP) in mandibular molars. However, pulpal inflammation notably decreases the anaesthetic efficacy by eight-fold in SIP cases. It has been reported in literature that the anaesthetic failure rate in SIP patients vary between 15-57% in mandibular molars . The reasons for such failures could be multi-factorial such as, decreased tissue pH, altered resting potentials, associated reduced thresholds in inflamed tissues, presence of tetrodotoxin-resistant (TTXr) sodium channels, lowered activation threshold of voltage gated sodium channels, activation of nociceptors, increase in pro-inflammatory cytokines in caries exposed pulps, in addition to the patient and operator related factors .

To overcome the difficulties and to improve the success of pulpal anaesthesia in SIP patients, various adjuvant methods are recommended which include, premedication with nonsteroidal anti-inflammatory drugs (NSAIDs), replacing lignocaine with articaine/bupivacaine/mepivacaine anesthetics and supplemental anaesthetic techniques such as, intraligamentary, intra-osseous and/ intra-pulpal anaesthesia. However, each supplementary technique/methods possess their own drawbacks. For instance, NSAIDs can increase the range of gastrointestinal problems and renal complications whereas replacement of lignocaine with other anesthetics like bupivacaine, mepivacaine or articaine results in anxiety, cardiotoxicity, blurred vision and gingival complications respectively. Intraligamentary method results in periodontal tissue damage and bacteremia whereas intra-osseous administration causes post injection discomfort and is a quite technique sensitive procedure. Further, intra-pulpal injections usually cause high patient discomfort.

Cryotherapy is a long-standing therapeutic technique that has frequently been applied in medicine for pain management and postoperative care. More recently, it has been reported that intraoral cryotherapy application on the vestibular surface of the treated mandibular molar for 5 mins after IANB application enhanced the anaesthetic success rate in SIP patients. The basic physiological tissue effects of cryotherapy include vascular and neurologic changes. If tissue is exposed to reduced temperatures, an initial reflex vasoconstriction occurs and is followed by cold-induced vasodilatation. This process occurs as a neural reflex triggered by the adrenergic elements of the blood vessels and decreases vascular permeability, thereby reducing tissue inflammation. Regarding the neurologic effect, cryotherapy induces analgesia by impeding the transmission of both A and C fibers. In addition, cold application might decrease the activation threshold of tissue nociceptors resulting in a local anaesthetic effect that is defined as cold induced neuropraxia.

Further, it was also reported that administration of precooled LA at 4-6 Â°C resulted in faster onset and improved anesthetic efficacy in both maxillary and mandibular molars in patients diagnosed with SIP. Cooling of LA increases the pKa value of lignocaine and this would further increase the cation to base ratio enhancing the anaesthetic potency, as cation form is the principal active local anaesthetic molecule.

A careful review of literature revealed that, the effect of intraoral cryotherapy application on pulpal anaesthesia following IANB administration using precooled LA 4-6 ÂºC in mandibular molars in SIP patients have not yet been reported. Further, comparative evaluation of precooled and conventional LA combined with intraoral cryotherapy application on the success of IANB anaesthesia has also not been studied (4). In addition, intraoral cryotherapy application was done for 5 mins in previous research studies.*.* Hence, the aim of the present study is to comparatively assess the pain on injection, onset and efficacy of pulpal anaesthesia following IANB using conventional LA and precooled LA 4-6 ÂºC with and without intraoral cryotherapy application for 2 minutes during endodontic treatment of mandibular molars in SIP patients.The proposed null hypothesis is that administration of precooled LA for IANB anaesthesia followed by intraoral cryotherapy application does not have any effect on the pain on injection, onset and efficacy of pulpal anaesthesia when compared to conventional LA.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

i) Male and female patients between the age group of 18-48 years.
ii) ASA class 1 or 2 patients.
iii) Preoperative pain scores â‰¥ 85 mm in HP-VAS scale iv) Mandibular molars with an endodontic pulpal diagnosis of symptomatic irreversible pulpitis.
v) Patients who had not taken any analgesics the day before and the day of the root canal procedure.

Exclusion Criteria

i) Patients who refuse to give informed consent.
ii) Teeth other than mandibular molars (incisors, canines, premolars).
v) Allergic to local anesthetics or any other drugs.
vi) Conditions that influence the pain scores, and with presence of periapical radiolucency, swelling, and sinus tract.
vii) Teeth with vertical fractures and periodontally compromised teeth.
viii) Non-restorable teeth.
x) Patients with blood dyscrasias of unknown origin, cold intolerance, Raynaudâ€™s disease, cold urticaria, cryoglobulinemia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the anaesthetic efficacy following IANB administration using precooled LA (4-6%)along with intraoral cryotherapy application in mandibular molars in symptomatic irreversible pulpitis patients.	Immediate

Secondary Outcome Measures

Name	Time	Method
To assess the pain on injection and onset of anaesthesia following IANB administration using precooled LA (4-6%)along with intraoral cryotherapy application in mandibular molars in symptomatic irreversible pulpitis patients.	Immediate

Trial Locations

Locations (1): SRM Dental College and Hospital
🇮🇳
Chennai, TAMIL NADU, India
SRM Dental College and Hospital
🇮🇳Chennai, TAMIL NADU, India
Vinoth Kumar M
Principal investigator
8870163263
vinothlinn29@gmail.com