INTRODUCTION Successful local anaesthesia is the backbone of pain control in endodontics. The inferior alveolar nerve (IAN) block is the most often used anaesthetic technique to achieve analgesia in mandibular molars. Irreversible pulpitis is a condition in which the pulp tissue is irreversibly inflamed and requires either pulpotomy, pulpectomy or extraction. Accomplishing adequate anaesthesia for sufficient time to be able to access and remove inflamed pulpal tissue is a challenge for the endodontist. Since 1948, lignocaine has maintained its status as the most widely used local dental anaesthetic worldwide. It has been shown to provide fast efficacy and excellent anaesthetic effect with low allergenicity and toxicity over long-term clinical use. Research studies have confirmed the value and safety of this drug. Supplementing local anaesthetics with a vasoconstrictor improves the success of anaesthesia by increasing its depth, duration, homeostasis and also maintains the anaesthetic within the injection site and reduces the risk of their systemic effects. Mepivacaine, an amide-type anaesthetic, has a low vasodilatory effect and 75% protein binding capability, both of which are responsible for its high duration and effectiveness. Its anaesthetic effect is satisfactory even when the drug is administered without a vasoconstrictor. It is therefore recommended in cases in which systemic conditions (i.e., cardiovascular compromised patients) restrict the use of vasoconstrictor (adrenaline). Mepivacaine has the lowest pKa (7.6) among all local anaesthetics; this enables its quick diffusion through the nerve membrane. Hypertension is defined as systolic and diastolic greater than 140 and 90 mmHg and also the individuals receiving antihypertensive treatments even if they have controlled blood pressure. The administration of epinephrine in hypertensive patients is associated with an increased risk. Thus, lignocaine without adrenaline and mepivacaine are used as alternatives to lignocaine with adrenaline. For pulpal anaesthesia, the inability to anesthetize the mandibular molar with irreversibly inflamed pulp poses a threat towards effective endodontic procedures. The term “Hot tooth†is used to describe a pulp with a diagnosis of Irreversible pulpitis exhibiting spontaneous pain with a moderate to severe category. Till date, there are only limited studies in the literature done to check the efficacy and pulpal anaesthesia in hypertensive patients. Thus, this study will be designed to compare the onset of pulpal anaesthesia and efficacy of 2% plain Lignocaine and 3% Mepivacaine in symptomatic irreversible pulpitis in normotensive and controlled hypertensive patients in mandibular permanent molars.
AIM To compare and evaluate the efficacy and pulpal anesthesia of 2% lignocaine and 3% mepivacaine in controlled hypertensive patients with symptomatic irreversible pulpitis.
OBJECTIVE 1. To evaluate the onset of pulpal anaesthesia of 2% lignocaine in normotensive and hypertensive patients. 2. To evaluate the onset of pulpal anaesthesia of 3% mepivacaine in normotensive and hypertensive patients. 3. To evaluate the efficacy of 2% lignocaine in normotensive and hypertensive patients. 4.To evaluate the efficacy of 3% mepivacaine in normotensive and hypertensive patients. 5.To compare and evaluate the efficacy and pulpal anesthesia of 2% lignocaine without adrenaline and 3% mepivacaine in normotensive and controlled hypertensive patients.
SAMPLE SIZE 92 teeth with symptomatic irreversible pulpitis will be selected and divided equally into four groups. GROUP 1A: 2% lignocaine in normotensive patients. GROUP 1B: 3% mepivacaine in normotensive patients. GROUP 2A: 2% lignocaine in hypertensive patients. GROUP 2B: 3% mepivacaine in hypertensive patients.
EXPERIMENTAL MATERIALS 1. 1.8ml Lignocaine plain [INDO CO] 2. 1.8ml Mepivacaine [Scandanest 3% plain, SEPTODEONT, LTD]
PROCEDURE Total 60 patients will be included in the study for a period of 12 months. The Blood pressure will be checked with sphygmomanometer in all the patients. Participating adults will be divided randomly into 4 different groups of 15 each. GROUP 1A-Normotensive patients: Patients receiving 2% lignocaine (n=15). GROUP 1B- Normotensive patients: Patients receiving 3% mepivacaine (n=15). GROUP 2A- Hypertensive patients: Patients receiving 2% lignocaine (n=15). GROUP 2B- Hypertensive patients: Patients receiving 3% mepivacaine (n=15). All the patients will be informed of possible risk, and consent form will be obtained. The diagnostic thermal sensibility test will be achieved by incorporating endofrost on a cotton pellet, which will be applied on the middle third of the buccal surface of the tooth until the patient responds (maximum 7 seconds). Patient should be trained for pain assessment with the adjacent tooth. Pre-operative pain will be measured before the commencement of the endodontic procedure as the base line data and pain on injection, pain on access cavity preparation & pain on endodontic instrumentation will be evaluated. Before any operative procedure, a test dose of local anaesthetic solution will be given for all the participating members to check for allergy to the corresponding material. In case of any complication, the materials for management of allergy will be kept ready5. Patients will be anesthetized using Inferior Alveolar Nerve Block by administering 2ml solution gradually over a period of 1 minute with the following: 2% Lignocaine without adrenaline [INDO CO] 3% Mepivacaine [Scandanest 3% plain, SEPTODEONT, LTD]
PULPAL ANESTHESIA CONFIRMATION Confirmation of lip numbness will be evaluated ten minutes post-injection by asking the participants to touch their lower lip and report whether his/her lip was numb. Time will be maintained with stop-watch for each patient and electric pulp stimulations will be done to confirm the pulpal anaesthesia. If profound lip numbness has not been achieved or the electric pulp tester has not reached 80μA without causing any sensation of pain, the patients will be excluded from the study. While assessing pulpal anaesthesia using EPT constant maximum output will be maintained.
POST-ANAESTHETIC ENDODONTIC PROCEDURES Approximately 15 minutes after the injection, rubberdam isolation is done and access cavity will be begun. During pulpectomy procedures, the patients will be instructed to report any painful discomfort. The patients will be requested to rate their pain intensity felt during the access cavity procedure in a VAS scale that entailed of a 10 cm straight ungraduated line starting from 0 to 10 which designated no pain to severe unbearable pain. The markings made by the patients will be then evaluated by a graduated scale by the second operator and the pain will be rated using the constant VAS scoring criteria: 0-4 – No pain 5-44 – Mild pain 45-74 – Moderate pain 75-100 – Severe pain. These pain ratings will be self-marked by all patients in the evaluation sheet and those sheets will be amassed by the dental assistant.
DETERMINATION OF ANAESTHETIC SUCCESS Anaesthetic efficacy will be defined as successful if the operator will be able to assess the pulp chamber without the patient reporting pain. In such situations the pulpectomy procedure will be continued. If the patient reported of pain during the procedure, they will be asked to rate their pain intensity in the VAS scale and the extent of access achieved will be documented as within dentin, pulp chamber or root canal. All pulpectomy procedures will be continued if every patient reports nil pain after the administration of supplementary anaesthetic injections. The dental assistant who will be aware of the anaesthetic solution administered gives the operator the same anaesthetic which will be used for the nerve block to administer as a supplementary injection. Before the participating patient leaves the clinic, the orofacial region will be examined for any adverse reactions.
FINAL DATA COLLECTION The compiled evaluation sheets by the dental assistant which contained the random number and the group in which the patients will be allocated and the pain rating done by the patients in the VAS scale will be evaluated by the second operator who performed the pulpectomy procedures. This evaluation will be done at the completion of the trial. The data regarding patient’s age, gender, tooth under study, pain ratings [mild, moderate, severe], type of supplementary anaesthetic administered will be entered in Microsoft Excel sheet and all these data will be subjected to the statistical analysis.
STATISTICAL ANALYSIS The data entry will be done in Microsoft Office Excel spread sheet. Data will be analyzed using appropriate software. Descriptive statistics including mean and standard deviation will be measured for age group of the participants involved in the study. ANOVA analysis will be done. |