Evaluation of Efficacy of Intraligamentary Anesthesia for Mandibular Molar Extractions

NCT ID: NCT05122819

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-13

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Intraligamentary Injection by Jet Injector

Group Type EXPERIMENTAL

Mandibular Molar Extraction Under Local Anesthesia

Intervention Type 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 B

Intraligamentary Injection by regular Dental Anesthesia Syringe

Group Type EXPERIMENTAL

Mandibular Molar Extraction Under Local Anesthesia

Intervention Type 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 C

Inferior Alveolar Nerve Block

Group Type ACTIVE_COMPARATOR

Mandibular Molar Extraction Under Local Anesthesia

Intervention Type 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).

Interventions

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Mandibular Molar Extraction Under Local Anesthesia

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).

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hamdard University

OTHER

Sponsor Role lead

Responsible Party

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Ayesha Basit

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hamdard University Dental Hospital

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Ayesha Basit, BDS, MCPS, FCPS

Role: CONTACT

923332257147

Maham Naeem, BDS, MBA

Role: CONTACT

923342886298

Facility Contacts

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Ayesha Basit, BDS, MCPS, FCPS

Role: primary

923332257147

Maham Naeem, BDS, MBA

Role: backup

923342886298

Other Identifiers

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(21)3-4161310

Identifier Type: -

Identifier Source: org_study_id

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