Clinical trial NCT05122819: Evaluation of Efficacy of Intraligamentary Anesthesia for Mandibular Molar Extractions
Official title: Evaluation of Efficacy of Intraligamentary Anesthesia by Two Different Techniques for Extraction of Mandibular Molars: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Local
Lead sponsor: Hamdard University
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* Patients not consenting to participate in the study.

Primary outcomes:
measure: Pain on injection
timeFrame: Immediately after local anesthesia administration regardless of the technique.
measure: Local anesthesia success
timeFrame: 1 minute after local anesthesia administration by intraligamentary injection regardless of the syringe used. 6 minutes after administration of Inferior Alveolar Nerve Block (IANB).
Secondary outcomes:
measure: Successful completion of Extraction
timeFrame: 45 minutes from the first administration of local anesthesia injection.
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Hamdard University Dental Hospital
state: Sind
Study officials:
References: