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Clinical Trials/NCT05122819
NCT05122819
Recruiting
Not Applicable

Evaluation of Efficacy of Intraligamentary Anesthesia by Two Different Techniques for Extraction of Mandibular Molars: A Randomized Controlled Trial

Hamdard University1 site in 1 country120 target enrollmentMay 13, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, Local
Sponsor
Hamdard University
Enrollment
120
Locations
1
Primary Endpoint
Pain on injection
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Dental extraction is the most common procedure undertaken in the department of Oral Surgery, inferior alveolar nerve block (IANB), till today, is the most commonly used local anaesthesia technique for extraction of lower posterior teeth. The anatomical complexity of this technique carries the risk of anaesthetic failures necessitating repeated needle penetrations and hence a painful experience for the patient. In addition, IANB technique, many times, becomes impossible to perform in fearful adult and paediatric patients, those with restricted mouth opening or intellectual disability. Certain coagulation defects are a contraindication to administration of IANB due to its depth of penetration into the tissues that may lead to fatal consequences in case of uncontrolled bleeding. Because of these shortcomings of IANB, there is always a need for alternative anaesthesia techniques that are less painful and carry lesser risks.

Anaesthetic injection into the Periodontal ligament space (space between tooth root surface and the bone forming the socket wall) as an alternative to IANB have been tested by many researchers with varying results. The expected advantages of this technique are reduced pain on injection, shorter duration of anaesthesia that prevents inadvertent lips and cheek biting after completion of the procedure. It is expected to be easier to perform in cases of restricted mouth opening and uncooperative patients due to any reason and carry lesser risk of bleeding within tissues.

The objective of our study is to evaluate the efficacy of Intra-ligamentary injection for posterior mandibular molar extraction as an alternative to inferior alveolar nerve block (IANB) so that it can be used in cases where IANB is either difficult to perform or not indicated.

Registry
clinicaltrials.gov
Start Date
May 13, 2022
End Date
December 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ayesha Basit

Associate Professor

Hamdard University

Eligibility Criteria

Inclusion Criteria

  • Age 18 years and above
  • Both genders.
  • Teeth selection: Mandibular first and second molars needing extraction under local anaesthesia.
  • Healthy patients or those with well controlled systemic disease.
  • Patients consenting to participate in the study.
  • Exclusion criteria:
  • Patients younger than 18 years.
  • Mandibular third molars, acutely inflamed or infected first and second molars.
  • Pregnant patients and those with poorly controlled systemic disease.
  • Mentally handicapped patients.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Pain on injection

Time Frame: Immediately after local anesthesia administration regardless of the technique.

Pain on injection will be checked by using Numeric Pain Rating Scale (NPRS). NPRS is an 11 point scale in which 0: no pain, 1-3: mild pain, 4-7: moderate pain, 8-10: worst possible pain.

Local anesthesia success

Time Frame: 1 minute after local anesthesia administration by intraligamentary injection regardless of the syringe used. 6 minutes after administration of Inferior Alveolar Nerve Block (IANB).

Local anesthesia success will be checked by using Numeric Pain Rating Scale (NPRS). NPRS is an 11 point scale in which 0: no pain, 1-3: mild pain, 4-7: moderate pain, 8-10: worst possible pain.

Secondary Outcomes

  • Successful completion of Extraction(45 minutes from the first administration of local anesthesia injection.)

Study Sites (1)

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