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

Not Applicable

Completed

• Conditions: Anesthesia, Local

• Registration Number: NCT05115773
• Lead Sponsor: Izmir Katip Celebi University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-02-25
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Study First Submitted: 2021-09-14
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-10
• Last Update Submitted: 2021-11-10
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Measurement of the injection pain of the local anesthesia using Wong Baker FACES pain rating scale.	Immediately after the local anaesthetic injection	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)
The measurements of dental pain using Visual Analogue Scale	Immediately after the working with a low-speed rotary instrument on dentin	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)
Practitioner's assessment of patient pain-related comfort	Immediately after the dental treatment	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
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	Baseline and immediately after the local anaesthetic injection	Measurement of arterial oxygen saturation and pulse rate using a pulse oximeter
The measurements of injection pain using Visual Analogue Scale	Immediately after the local anaesthetic injection	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)
Measurement of the pain perception during the dental procedures using Wong Baker FACES pain rating scale.	Immediately after the working with a low-speed rotary instrument on dentin	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)
Rate of post-op complication	Day after intervention	Query the presence of post-op complications related to local anaesthesia

Secondary Outcome Measures

Name	Time	Method
Evaluate the correlation between two self reported objective pain scales	Immediately after the local anaesthetic injection	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.

Trial Locations

Locations (1)

Izmir Katip Celebi University; 🇹🇷 İzmir, Turkey