Clinical trial NCT05115773: Comparison of The Effectiveness of Intraligamentary and Mandibular Anesthesia on Mandibular Molar Teeth
Official title: Comparison of The Effectiveness of Intraligamentary and Mandibular Anesthesia on Mandibular Molar Teeth: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Keywords: intraligamentary anesthesia
inferior alveolar nerve block
paediatric dentistry
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 78
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized controlled, single-blind, split-mouth clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The measurements of dental pain using Visual Analogue Scale
timeFrame: Immediately after the working with a low-speed rotary instrument on dentin
measure: The measurements of injection pain using Visual Analogue Scale
timeFrame: Immediately after the local anaesthetic injection
measure: Measurement of the pain perception during the dental procedures using Wong Baker FACES pain rating scale.
timeFrame: Immediately after the working with a low-speed rotary instrument on dentin
measure: Measurement of the injection pain of the local anesthesia using Wong Baker FACES pain rating scale.
timeFrame: Immediately after the local anaesthetic injection
measure: 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
timeFrame: Baseline and immediately after the working with a low-speed rotary instrument on dentin
measure: 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
timeFrame: Baseline and immediately after the local anaesthetic injection
measure: Practitioner's assessment of patient pain-related comfort
timeFrame: Immediately after the dental treatment
measure: Rate of post-op complication
timeFrame: Day after intervention
Secondary outcomes:
measure: Evaluate the correlation between two self reported objective pain scales
timeFrame: Immediately after the local anaesthetic injection
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Katip Celebi University
Study officials:
affiliation: İzmir Katip Çelebi University Faculty of Dentistry
name: Funda Çağırır Dindaroğlu, Asst. Prof.
role: STUDY_DIRECTOR
affiliation: Private Practice
name: Ece Yılmaz, DDS
role: PRINCIPAL_INVESTIGATOR
References: