Evaluation of Efficacy of Intraligamentary Anesthesia for Mandibular Molar Extractions

NCT05122819 | Unknown

• 1 other identifier: (21)3-4161310
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (2)

• Pain on injection

  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.

  Immediately after local anesthesia administration regardless of the technique.

• Local anesthesia success

  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.

  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 (1)

• Successful completion of Extraction

  45 minutes from the first administration of local anesthesia injection.

Study Arms (3)

Group A

EXPERIMENTAL

Intraligamentary Injection by Jet Injector

Procedure: Mandibular Molar Extraction Under Local Anesthesia

Group B

EXPERIMENTAL

Intraligamentary Injection by regular Dental Anesthesia Syringe

Procedure: Mandibular Molar Extraction Under Local Anesthesia

Group C

ACTIVE COMPARATOR

Inferior Alveolar Nerve Block

Procedure: Mandibular Molar Extraction Under Local Anesthesia

Interventions

Mandibular Molar Extraction Under Local Anesthesia PROCEDURE

Local Anaesthetic to be used: 2% Lidocaine in 1.8 ml cartridge (regularly used for dental anaesthesia regardless of the technique). Pain on injection and local anaesthesia success will be checked by using numeric pain rating scale (NPRS).

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamdard University: lead

Study Sites (1)

Hamdard University Dental Hospital

Karachi, Sindh, Pakistan

RECRUITING

Central Study Contacts

Ayesha Basit, BDS, MCPS, FCPS

CONTACT

923332257147; ayeshabasitpk@gmail.com

Maham Naeem, BDS, MBA

CONTACT

923342886298; drmaham.naeem@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 17, 2021
• Study Start: May 13, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)