Skip to main content
OpenTrials
Completed

NCT Number: NCT05115773

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia, Local

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Katip Celebi University

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraligamentary anaesthesia

Procedure

one tooth anaesthesia by 2 or 4 points intraligamentary injection

Other names: 2 or 4 points intraligamentary injection

Mandibular anaesthesia

Procedure

Inferior alveolar nerve block by direct standart method

Other names: Inferior alveolar nerve block

Primary outcomes

  1. The measurements of dental pain using Visual Analogue Scale

    Time frame: 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)

  2. The measurements of injection pain using Visual Analogue Scale

    Time frame: 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)

  3. Measurement of the pain perception during the dental procedures using Wong Baker FACES pain rating scale.

    Time frame: 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)

  4. Measurement of the injection pain of the local anesthesia using Wong Baker FACES pain rating scale.

    Time frame: 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)

  5. 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

    Time frame: Baseline and immediately after the working with a low-speed rotary instrument on dentin

    Measurement of arterial oxygen saturation and pulse rate using a pulse oximeter

  6. 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

    Time frame: Baseline and immediately after the local anaesthetic injection

    Measurement of arterial oxygen saturation and pulse rate using a pulse oximeter

  7. Practitioner's assessment of patient pain-related comfort

    Time frame: 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

  8. Rate of post-op complication

    Time frame: Day after intervention

    Query the presence of post-op complications related to local anaesthesia

Secondary outcomes

  1. Evaluate the correlation between two self reported objective pain scales

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 10, 2021
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.