Comparison of The Effectiveness of Intraligamentary and Mandibular Anesthesia on Mandibular Molar Teeth

Anesthesia, Local Clinical Trial

Official title:

Comparison of The Effectiveness of Intraligamentary and Mandibular Anesthesia on Mandibular Molar Teeth: A Randomized Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05115773
• Other study ID #: 2019-TDU-DISF-0013
• Status: Completed
• Phase: N/A
• Start date: February 25, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: November 2021
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to compare the effects of mandibular and intraligamentary anesthesia techniques on pain scores during restorative treatment of permanent mandibular molars in pediatric patients. Additionally, comparing the anesthesia techniques in terms of injection pain, the success of anesthesia, postoperative complications, and the subjects' preference was planned.

This randomized, controlled, cross-over, single-blind, split-mouth study was conducted on 78 subjects aged 6 to 12 years. Subjects with enamel-dentin caries on the bilateral permanent mandibular molar were included.

Description:

First, the subjects who met the inclusion criteria in the study were included in 2 study groups according to age, gender, dental experience, DMFT / dmft values, and ICDAS II and radiographic evaluation criteria. Two different anesthesia techniques were applied to the right / left permanent first molar teeth of the patients included in the study, with an interval of one week. The subjects have been divided into two groups as 39 subjects were Group 1 received intraligamentary anesthesia in the first visit, and 39 subjects were Group 2 received mandibular anesthesia in the first session. The pain perception rates of the patients during the injection and treatment phases were recorded subjectively using a visual analog scale and Wong-Baker FACES pain rating scale. Heart rate and arterial oxygen saturation were determined as the physiological parameters. The quality of anesthesia and success were evaluated by the operation at the end of each visit. Complications (pain, raised teeth, hematoma, trauma due to lip/tongue bites, swelling, infection, and bleeding) were explained to the patients after anesthesia. They were asked to take note of the complications they encountered. Postoperative complications were recorded by calling the cases 1 day after the 1st and 2nd visits. At the end of the second visit, anesthesia preference of the patient was asked and recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Subjects with American Society of Anesthesiologists score I (ASA I)

• Subjects with Frankl's behavior rate III (positive) and IV (definitely positive),

• Subjects with indication of similar restoration treatment on bilateral first permanent mandibular molars

• Subjects whose plaque index score of 0 (no plaque) and 1

• Subjects whose gingival index score of 0

Exclusion Criteria:

• Allergic to the local anesthetics or sulfites

• Subjects with cholinesterase deficiency

• Subjects who use drugs that may affect the assessment of pain, such as narcotic or non-narcotic analgesic, anti-inflammatory, anxiolytic, antipsychotic and antihistamine agents

• Subjects who need to use sedatives or other medications during dental procedures

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Procedure:
• Intraligamentary anaesthesia
one tooth anaesthesia by 2 or 4 points intraligamentary injection
• Mandibular anaesthesia
Inferior alveolar nerve block by direct standart method

Locations

Country	Name	City	State
Turkey	Izmir Katip Celebi University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The measurements of dental pain using Visual Analogue Scale	Subjective pain perception scores during the intervention using Visual Analogue Scale containing Numeric Rating Scale (0-10, where 0 means no pain/best, 10 - worst possible pain)	Immediately after the working with a low-speed rotary instrument on dentin
Primary	The measurements of injection pain using Visual Analogue Scale	Subjective pain perception scores after the local anesthetic injection using Visual Analogue Scale containing Numeric Rating Scale (0-10, where 0 means no pain/best, 10 - worst possible pain)	Immediately after the local anaesthetic injection
Primary	Measurement of the pain perception during the dental procedures using Wong Baker FACES pain rating scale.	Subjective pain perception scores using Wong Baker Faces pain rating scale (Face 0: it does not hurt/best, Face 2: it hurts a little, Face 4: it hurts a little more, Face 6: it hurts more, Face 8: it hurts a lot, Face 10: it hurts a lot/worst)	Immediately after the working with a low-speed rotary instrument on dentin
Primary	Measurement of the injection pain of the local anesthesia using Wong Baker FACES pain rating scale.	Subjective pain perception scores using Wong Baker Faces pain rating scale (Face 0: it does not hurt/best, Face 2: it hurts a little, Face 4: it hurts a little more, Face 6: it hurts more, Face 8: it hurts a lot, Face 10: it hurts a lot/worst)	Immediately after the local anaesthetic injection
Primary	Change from baseline physiological parameters (arterial oxygen saturation and pulse rate) at the end of the working with a low-speed rotary instrument on dentin	Measurement of arterial oxygen saturation and pulse rate using a pulse oximeter	Baseline and immediately after the working with a low-speed rotary instrument on dentin
Primary	Change from baseline physiological parameters (arterial oxygen saturation and pulse rate) at the end of the working with a low-speed rotary instrument on dentin	Measurement of arterial oxygen saturation and pulse rate using a pulse oximeter	Baseline and immediately after the local anaesthetic injection
Primary	Practitioner's assessment of patient pain-related comfort	Practitioner's subjective records: cases who need additional mandibular anaesthesia, whose treatment is completed without a discomfort related to pain, who has a slight discomfort even though additional mandibular anaesthesia is not needed during the treatment	Immediately after the dental treatment
Primary	Rate of post-op complication	Query the presence of post-op complications related to local anaesthesia	Day after intervention
Secondary	Evaluate the correlation between two self reported objective pain scales	The correlation between the scores of Wong Baker Faces pain rating scale (Face 0: it does not hurt/best, Face 2: it hurts a little, Face 4: it hurts a little more, Face 6: it hurts more, Face 8: it hurts a lot, Face 10: it hurts a lot/worst) and Visual Analogue Scale for pain (0-10, where 0 means no pain/best, 10 - worst possible pain) recorded after the local anaesthetic injection in 6-12 years old patients. For the Wong Baker FACES pain rating scale, the maximum value (10) means "it hurt a lot" is the worst and the minimum value (0) means "it does not hurt" is the best outcome. For the Visual Analogue Scale for pain containing Numeric Rating Scale , while the minimum value (0) means "no pain" is the best outcome, the maximum value (10) means "worst possible pain" is the worst outcome.	Immediately after the local anaesthetic injection