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Evaluation of Efficacy of Intraligamentary Anesthesia for Mandibular Molar Extractions

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05122819
Enrollment
120
Registered
2021-11-17
Start date
2022-05-13
Completion date
2023-12-31
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local

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.

Interventions

PROCEDUREMandibular 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).

Sponsors

Hamdard University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain on injectionImmediately 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 success1 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

MeasureTime frameDescription
Successful completion of Extraction45 minutes from the first administration of local anesthesia injection.Completion of extraction within 45 minutes, without changing the intervention. It will be measured on the following parameters: 1. Local anesthesia success by NPRS after first administration of Intraligamentary injection (first primary outcome measure mentioned above). 2. Local anesthesia success by NPRS after second administration of intraligamentary injection (need to repeat the same technique). 3. Local anesthesia failure by Intraligamentary injection administered twice (as mentioned above) and need to change the technique to conventional Inferior Alveolar Nerve Block (IANB).

Countries

Pakistan

Contacts

Primary ContactAyesha Basit, BDS, MCPS, FCPS
ayeshabasitpk@gmail.com923332257147
Backup ContactMaham Naeem, BDS, MBA
drmaham.naeem@gmail.com923342886298

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026