Efficacy of Differents Anaesthetics in Mandibular Third Molar Germectomy

NCT04465149 | Completed

• 1 other identifier: SecondUNI-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: To compare the clinical efficacy of local anaesthetics with articaine 4% or mepivacaine 2% (both with epinephrine 1:100.000) using different anaesthetic techniques to perform germectomy of lower third molars and to assess patients' feelings and pain during surgery. Methods: 50 patients (ranged 11-16 years) who required germectomy of mandibular third molars were recruited. Each patient received local anaesthesia on one side with articaine inoculated with plexus technique while on the other side with mepivacaine using inferior alveolar nerve block technique. The patients' evaluation was performed on pre and intraoperative tactile-pressure feelings and intraoperative pain with four levels on the analogic visual scale (VAS).

Conditions

Local Anesthetic Efficacy

Outcome Measures

Primary Outcomes (1)

• Discomfort/Pain felt for anesthetic injection valued by the Patient on a Visual Analogue Scale

  Once performed the injections, patients were asked to notice on a visual analogue scale, how much discomfort they felt due to the anaesthetic injections, indicating one of the following values: 0 absent 1. mild 2. moderate 3. severe

  At the beginning of Surgery

Secondary Outcomes (1)

• Test during the Surgery

  After 10/15 minutes

Study Arms (1)

Patients

EXPERIMENTAL

Patients who required germectomy of mandibular third molars. Each patient received local anaesthesia on one side with articaine inoculated with plexus technique while on the other side with mepivacaine using inferior alveolar nerve block technique.

Procedure: Third Molar Germectomy

Interventions

Third Molar Germectomy PROCEDURE

Surgical extraction of Third Molars that exhibits at least a third of its root in formation, with a periodontal ligament discernible on panoramic x-ray (defined as germectomy).

Patients

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients requiring bilateral germectomy of mandibular third molars before orthodontic treatment

You may not qualify if:

• Patients presenting systemic and oral diseases

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Campania Luigi Vanvitelli

Napoli, 80131, Italy

Location

Related Publications (38)

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Study Officials

• Marco Menditti, Doctor

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Model Details: The subjects were children undergoing orthodontic treatment in whom early extraction was indicated to facilitate their treatment in some specific conditions (i.e. posterior crowding, altered second molar eruption, non-extraction approach). For each subject, the first germectomy was scheduled 15 days apart. The same senior operator, assisted by the same practitioner, completed all the surgical procedures. All interventions made with mepivacaine were performed with the same anaesthetic technique routinely used in Oral surgery (IANB). The technique was complemented with anaesthesia of the buccal nerve, as routine for this technique, administering another 1.8 ml of the same anaesthetic used in each intervention. On the other hand, the surgical procedures in articaine cases were made practising a plexus technique, performing a deep buccal injection distally to the second mandibular molar.

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: July 9, 2020
• Study Start: June 30, 2018
• Primary Completion: October 31, 2019
• Study Completion: April 20, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)