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Computer - Controlled Intraligamentary Local Anaesthesia In Extraction of Primary Molars

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ClinicalTrials.gov Identifier: NCT04739735
Recruitment Status : Completed
First Posted : February 5, 2021
Results First Posted : January 10, 2022
Last Update Posted : January 10, 2022
Sponsor:
Information provided by (Responsible Party):
Rodaina Helmy, Alexandria University

Brief Summary:

Background: Exodontia poses a psychological threat for children, increasing the need for profound local anesthesia to assure painless extraction and maintain child cooperation on the dental chair. Computer-controlled Intraligamentary anesthesia (CC-ILA) affects only the tooth to be treated with minimal pressure, eliminating the side effects of other conventional techniques.

Purpose of the study: To evaluate the effectiveness of CC-ILA injection in eliminating pain during extraction of mandibular primary molars compared to inferior alveolar nerve block (IANB) technique. The null hypothesis is there will be no difference in the pain experience with the use of CC-ILA compared to the IANB in pediatric patients.

Method: The study will be a double-blind randomized controlled clinical trial, parallel design. A total of 50 healthy children aged 5-7 years, will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 Frankl behavioral rating scale. Each child selected will have at least one mandibular primary molar that is indicated for extraction. Written informed consent will be obtained from guardian. Participants will be randomly allocated into two groups according to the technique of anesthesia that will be used. Group I (test group) will receive CC-ILA, while group II (control group) will receive IANB. Heart rate will be used as vital parameter of pain, and will be recorded at base line, during injection and during extraction procedure. Pain reaction will be assessed objectively by two investigators using Sensory, Eye, Motor (SEM) scale, while subjectively the pain will be evaluated by asking the child to express his experience using a modified face scale from the Maunuksela scale.


Condition or disease Intervention/treatment Phase
Local Anaesthetic Drug Adverse Reaction Procedure: Dental Local Anaesthesia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The study will be a two-arm randomized controlled clinical trial. It will be setup and reported according to the CONSORT guidelines.

Participants will be randomly and equally allocated to one of the two arms (Figure 1).

  • Group I: (experimental group n = 25) assigned to CC-ILA.
  • Group II: (control group n = 25) assigned to conventional injection by IANB.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The researcher (operator) who will perform all the injections and extractions as well as record heart rate measurements cannot be blinded to the type of intervention; a second impartial observer (evaluator) will record the Sensory, Eye, Motor (SEM) scale independently. The statistician will be blinded to the treatment groups. Since the participants will also be blinded, therefore, the study will be triple-blind.
Primary Purpose: Treatment
Official Title: Effectiveness of Computer - Controlled Intraligamentary Local Anaesthesia In Extraction of Mandibular Primary Molars: Randomised Controlled Clinical Trial
Actual Study Start Date : March 2, 2021
Actual Primary Completion Date : August 12, 2021
Actual Study Completion Date : October 1, 2021

Arm Intervention/treatment
Experimental: Computer Controlled -Intraligamentary Anaesthesia (CC-ILA)

CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth.

Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle.

Procedure: Dental Local Anaesthesia
lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously

Active Comparator: Conventional Injection of Inferior Alveolar Nerve Block
  • In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva.
  • A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met.

Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered.

Procedure: Dental Local Anaesthesia
lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously




Primary Outcome Measures :
  1. Baseline Heart Rate [ Time Frame: mean measurement when the child is seated on the dental chair until right before the injection at 2 minute intervals. time frame was approximately Minute 0 - 2 ]
    Heart Rate will be measured using a pulse oximeter placed on child's index finger. Readings will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.

  2. Heart Rate Measurement in Local Anaesthetic Administration [ Time Frame: starting from needle puncture till full local anaesthetic solution delivery. Time frame is approximately minute 2 - 4. ]
    Heart Rate will be measured using a pulse oximeter placed on child's index finger. Readings will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.

  3. Heart Rate Measurement in Extraction [ Time Frame: patient was allowed to rest for approximately 5 minutes after the injection then extraction was started. Time frame is approximately minute 9 -10 ]
    Heart Rate will be measured using a pulse oximeter placed on child's index finger. Readings will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.

  4. SEM Scale in Local Anaesthetic Administration [ Time Frame: approximately minute 2 - 4 ]
    Sound, Eye, Motor (SEM) Scale, comprises the following parameters: (1) Sound, (2) Eye, (3) Motor. For each child, the sounds, eye symptoms and body movements will be evaluated independently by a blind impartial observer using the recorded video tapes. The slightest manifestation of the sound, eyes, or motion of the patient is graded in four levels: comfort, mild, moderate, and severe discomfort, and subsequently given grades 1, 2, 3, 4, respectively. SEM score will be calculated by summing the three grades of the parameters.

  5. SEM Scale in Extraction [ Time Frame: approximately minute 9 - 10 ]
    Sound, Eye, Motor (SEM) Scale, comprises the following parameters: (1) Sound, (2) Eye, (3) Motor. For each child, the sounds, eye symptoms and body movements will be evaluated independently by a blind impartial observer using the recorded video tapes. The slightest manifestation of the sound, eyes, or motion of the patient is graded in four levels: comfort, mild, moderate, and severe discomfort, and subsequently given grades 1, 2, 3, 4, respectively. SEM score will be calculated by summing the three grades of the parameters.

  6. Face Pain Rating Scale in Local Anaesthetic Administration [ Time Frame: approximately minute 2 - 4 ]
    A modified face scale from the Maunuksela et al scale will be used to subjectively record pain during LA injection and extraction. It consists of three schematic faces with different facial expressions for happy and sad faces representing: (A) satisfaction; (B) indifference; and (C) dissatisfaction, respectively.

  7. Face Pain Rating Scale in Extraction [ Time Frame: approximately minute 9 - 10 ]
    A modified face scale from the Maunuksela et al scale will be used to subjectively record pain during LA injection and extraction. It consists of three schematic faces with different facial expressions for happy and sad faces representing: (A) satisfaction; (B) indifference; and (C) dissatisfaction, respectively.


Secondary Outcome Measures :
  1. Assessment of Occurrence of Adverse Events [ Time Frame: after 24 hours ]
    Parents will be recalled after 24 hours following extraction during follow-up phone calls. Recovery parameter questions will be asked to ascertain the occurrence of lip and cheek biting, post-operative pain, or any adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age range from 5 - 7 years.
  • Children free of any systemic disease or special health care need (ASA I).
  • No previous bad dental experience.
  • Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4).
  • Patients whom their mandibular primary molars are indicated for extraction:

    • Clinical signs and sympmtoms of pulp degeneration, such as swelling or sinus tracts.
    • Radiographic evidence of periapical or interradicular radiolucency.
    • Non restorable crowns.
    • Failed pulpotomies.
  • Patients whose parents will give their consent to participate.

Exclusion Criteria:

  • Root resorption affecting more than one third of the root length.
  • Fractured roots due to trauma.
  • Signs of mobility.
  • Ankylosed roots.
  • Active sites of pathosis in area of injection that could affect anaesthetic assessment.
  • History of allergy to local anesthesia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04739735


Locations
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Egypt
Alexandria University
Alexandria, Egypt
Sponsors and Collaborators
Alexandria University
Investigators
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Principal Investigator: Rodaina H Helmy Instructor, Pediatric Dentistry and Dental Public Health Department
  Study Documents (Full-Text)

Documents provided by Rodaina Helmy, Alexandria University:
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rodaina Helmy, Instructor, Pediatric Dentistry and Dental Public Health Department,Faculty of Dentistry, Alexandria University, Alexandria University
ClinicalTrials.gov Identifier: NCT04739735    
Other Study ID Numbers: 00010556 - 0008839
First Posted: February 5, 2021    Key Record Dates
Results First Posted: January 10, 2022
Last Update Posted: January 10, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: through publishing manuscripts so that other researchers could benefit from the study too.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: By August 2021
Access Criteria: it will be open access to anyone interested in research

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rodaina Helmy, Alexandria University:
Computer - controlled
Intraligamentary
Local anesthesia
Nerve block
Articaine
Pain
Extraction
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs