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Completed

NCT Number: NCT06611865

Comparison of Intraligamentary Anesthesia With the Inferior Alveolar Nerve Block for the Extraction of Mandibular Molars.

Local anaesthesia or numbing is done before tooth extraction. This study compares two different methods of numbing molar teeth before extraction. It compares them on the basis of pain during the procedure and on discomfort after the procedure as well. It will help dentists better understand the benefits of the two techniques, and their usage case to case.

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Key information

Conditions

Tooth Extraction Dry Socket Mouth Diseases Stomatognathic Diseases Tooth Extraction Site Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nishtar Institute of Dentistry

Multan, Punjab Province, 60000, Pakistan

About this study

The study was designed as a randomized controlled trial. The purpose of this study was to examine the differences in efficacy of the intraligamentary anaesthetic technique and the inferior alveolar nerve block for mandibular posterior tooth extraction cases. Pain intensity, duration of anaesthesia, incidence of post-operative dry socket, success rates, onset of anaesthesia were examined. It was done in a split-mouth method so that two different techniques were used in the same patient, thus minimizing individual variations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of both sexes who were more than 18 years of age; they had indications of non-surgical extraction of one or multiple mandibular posterior teeth.

Exclusion criteria

  • For patients: pregnancy, immunological compromise, systemic conditions requiring special considerations and non-compliance.
  • The exclusion criteria for individual teeth were: acutely infected teeth or any teeth with the instances of expression of pus through sinus tracts or the gingival sulcus were excluded. In case of multiple unilaterally indicated teeth that were to be extracted under IANB, only the tooth best fitting all criteria was considered for the study.

Treatment and study plan

Intraligamentary anaesthesia

Procedure

Injection of anesthetic solution into the intraligamentary space along the long axis of a tooth root using a pressure syringe.

Inferior Alveolar Nerve Block

Procedure

Anaesthetic injection into the pterygomandibular space to block the Inferior alveolar nerve at the mandibular foramen point.

Primary outcomes

  1. Injection pain

    Time frame: Through the duration of injection (within a few seconds to 1 minute)

    Rating of injection administration pain from 0-10.

  2. Pain during extraction procedure

    Time frame: For the duration of treatment (estimated within 1 hour)

    Pain during extraction procedure on a scale of 0-10.

  3. Unpleasantness of treatment

    Time frame: For the duration of treatment (estimated within 1 hour)

    A rating of 0-10 for overall discomfort felt by the patient during the treatment.

  4. Latency time of anesthesia (minutes)

    Time frame: Anesthesia was tested with a dental probe on the marginal gingiva at: 1) immediately after the injection and 2) every 10 seconds (ILA) / every 30 seconds (IANB) until complete painlessness was achieved.

    The onset of anesthesia after injection

  5. Anesthetic effect

    Time frame: For the duration of treatment (estimated within 2 hours)

    4 categories: Complete, sufficient, insufficient or no effect.

  6. Amount of anesthetic solution (mL)

    Time frame: For the duration of treatment (estimated within 1 hour)

    The average amount of anaesthetic solution injected per procedure.

  7. Duration of treatment (minutes)

    Time frame: For the duration of treatment (estimated up to 1 to 2 hours)

    Time in minutes taken from the injection to the complete extraction of tooth.

  8. Duration of local numbness (minutes)

    Time frame: For the duration of treatment (estimated up to 1 to 2 hours)

    Total duration of local numbness reported by the patient

Secondary outcomes

  1. Incidence of Dry socket

    Time frame: From the complete extraction of tooth to 14 days after the extraction of tooth

    Dry socket incidence reported by the patient int he recovery period of 14 days

Sponsors and collaborators

Lead sponsor

Hamza Zia Ahmed

Other

Registry information

Official study title

Cross-sectional Study Documenting the Relative Efficacy of Intraligamentary Anesthesia and the Inferior Alveolar Nerve Block for the Extraction of Posterior Mandibular Teeth.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

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.

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