Buffered Anesthetic Solution in the Treatment of Mandibular Primary Molars

NCT05793905 | Completed Phase 4

• 1 other identifier: UDDS-Pedo-03-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In a prospective, randomized clinical trial, triple-blind, split-mouth study, 40 children aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis. The test agent was 2% lidocaine with 1:80.000 epinephrine buffered with sodium bicarbonate 8.4% at a ratio of 1/10, as opposed to the control agent, which was non- buffered 2% lidocaine with 1:80,000 epinephrine. The pain will be assessed during inferior alveolar nerve block injection (IANB) and the effectiveness of anesthesia using the subjective Wong-Baker visual analog scale, the objective sound, eye, and motor (SEM) scale, and the physiological pain scale (pulse rate) using a pulse oximeter. The investigator has confirmed the onset of anesthesia after lip tongue-numbing by probing the gingiva until there is no pain. Endo-ice has been used to assess the onset of pulp anesthesia.

Conditions

Local Anesthesia

Keywords

Buffered lidocaine

Outcome Measures

Primary Outcomes (6)

• Probing the gingiva

  The onset of anaesthesia at soft tissue will be assessed by probing the gingiva After IANB injection.

  directly after asking the child about lip, tongue numbing every 30 seconds until there is no pain.

• Endo - ice test

  The investigator will use endo-ice to assess the onset time of pulp anaesthesia.

  Every 30 seconds after confirmed soft tissues anaesthesia until the absence of pain.

• Pulse rate

  Pulse rate is a physiological pain scale which will be taken through a finger pulse oximeter.

  A minute before anaesthesia.

• Pulse rate

  Pulse rate is a physiological pain scale, will be taken through a finger pulse oximeter.

  20 seconds after the first quarter of the local anaesthesia.

• Wong baker faces scale.

  Wong Baker faces scale is a subjective pain which contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst"

  One minute after IANB injection

• Sound, eye, motor scale (SEM)

  Sound, eye, motor scale is an objective pain scale for the assessment of child's behaviour by recording video during anaesthesia

  Within five seconds from the start of the local anesthetic injection to completion

Secondary Outcomes (3)

• Pulse rate

  20 seconds after opening the pulp chamber

• Wong baker faces scale

  one minute after preparing pulp chamber

• sound, eye, motor scale (SEM)

  Within five seconds from the start of the local anaesthetic injection to completion

Study Arms (2)

Buffered lidocaine

EXPERIMENTAL

Inferior alveolar nerve block with buffered anesthetic solution (2% lidocaine with 1/80000 adrenaline mixed with sodium bicarbonate 8.4%)

Combination Product: Buffered lidocaine in inferior alveolar nerve block injection

Lidocaine 2%

OTHER

Control group: Inferior alveolar nerve block with anesthetic solution (Lidocaine 2% with adrenaline 1.80000).

Drug: lidocaine 2% in inferior alveolar nerve block injection

Interventions

Buffered lidocaine in inferior alveolar nerve block injection COMBINATION_PRODUCT

Buffered Lidocaine 2% with epinephrine 1.80000 mixed with 1.8% sodium bicarbonate in IANB injection in the treatment of bilateral primary mandibular molars

Also known as: Buffered lidocaine

Buffered lidocaine

lidocaine 2% in inferior alveolar nerve block injection DRUG

Lidocaine 2% with epinephrine 1.80000 in IANB injection in the treatment of bilateral primary mandibular molars

Lidocaine 2%

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children who are healthy and free of any underlying conditions that might make local anesthesia impossible to administer.
• Children that are not allergic to (lidocaine, adrenaline, or sodium bicarbonate).
• Children aged 6-10 years old
• Cooperative children on Frankel scale (positive or absolute positive).
• children needing bilateral (right and left) endodontic treatment for the mandibular primary molars.
• A positive outcome on the cold test for the target tooth.

You may not qualify if:

• Uncooperative children on Frankel's scale (passive or absolute positive).
• The presence of a fistula.
• The presence of an abscess associated with the target tooth.
• The presence of a periapical lesion radially.
• Negative response to the cold test.
• Children suffering from systemic conditions.
• Children who are allergic to (lidocaine, adrenaline, sodium bicarbonate).

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

College of dentistry.

Damascus, Al-Mazzeh Saint, Damascus P.O.Box 3062, Syria

Location

Related Publications (4)

• Chopra R, Jindal G, Sachdev V, Sandhu M. Double-Blind Crossover Study to Compare Pain Experience During Inferior Alveolar Nerve Block Administration Using Buffered Two Percent Lidocaine in Children. Pediatr Dent. 2016 Jan-Feb;38(1):25-9.

  PMID: 26892211 RESULT

• Goodchild JH, Donaldson M. Novel Direct Injection Chairside Buffering Technique for Local Anesthetic Use in Dentistry. Compend Contin Educ Dent. 2019 Jul/Aug;40(7):e1-e10.

  PMID: 31478693 RESULT

• Meincken M, Norman C, Arevalo O, Saman DM, Bejarano T. Anesthesia Onset Time and Injection Pain Between Buffered and Unbuffered Lidocaine Used as Local Anesthetic for Dental Care in Children. Pediatr Dent. 2019 Sep 15;41(5):354-357.

  PMID: 31648665 RESULT

• Kurien RS, Goswami M, Singh S. Comparative evaluation of anesthetic efficacy of warm, buffered and conventional 2% lignocaine for the success of inferior alveolar nerve block (IANB) in mandibular primary molars: A randomized controlled clinical trial. J Dent Res Dent Clin Dent Prospects. 2018 Spring;12(2):102-109. doi: 10.15171/joddd.2018.016. Epub 2018 Jun 20.

  PMID: 30087760 RESULT

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Chaza Kouchaji, Professor

  Supervisal

  STUDY DIRECTOR

• Hanadi Almattit, Phd,lecturer

  Co- supervisal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple Masking: Patients, Investigators and Statistician
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This clinical research aims to evaluate the effectiveness of buffered lidocaine in the treatment of bilateral primary molars

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 31, 2023
• Study Start: December 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 3, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)