N/A
N=50
Computer - Controlled Intraligamentary Local Anaesthesia In Extraction of Primary Molars
Local Anaesthetic Drug Adverse Reaction
Bottom Line
View on ClinicalTrials.gov: NCT04739735 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Baseline Heart Rate — 99.92; 98.80 beats per minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dental Local Anaesthesia (Procedure)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Alexandria University
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Heart Rate |
99.92; 98.80 | — |
| PRIMARY Heart Rate Measurement in Local Anaesthetic Administration |
104.64; 113.48 | — |
| PRIMARY Heart Rate Measurement in Extraction |
107.68; 114.44 | — |
| PRIMARY SEM Scale in Local Anaesthetic Administration |
3; 9 | — |
| PRIMARY SEM Scale in Extraction |
4; 7 | — |
| PRIMARY Face Pain Rating Scale in Local Anaesthetic Administration |
22; 14; 2; 0; 1; 11 | — |
| PRIMARY Face Pain Rating Scale in Extraction |
21; 13; 2; 0; 2; 12 | — |
| SECONDARY Assessment of Occurrence of Adverse Events |
0; 8; 5; 10 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04739735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.