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
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First Submitted Date ICMJE | January 26, 2021 | ||||||||||||||||
First Posted Date ICMJE | February 5, 2021 | ||||||||||||||||
Results First Submitted Date ICMJE | October 14, 2021 | ||||||||||||||||
Results First Posted Date ICMJE | January 10, 2022 | ||||||||||||||||
Last Update Posted Date | January 10, 2022 | ||||||||||||||||
Actual Study Start Date ICMJE | March 2, 2021 | ||||||||||||||||
Actual Primary Completion Date | August 12, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE |
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.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | Computer - Controlled Intraligamentary Local Anaesthesia In Extraction of Primary Molars | ||||||||||||||||
Official Title ICMJE | Effectiveness of Computer - Controlled Intraligamentary Local Anaesthesia In Extraction of Mandibular Primary Molars: Randomised Controlled Clinical Trial | ||||||||||||||||
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. |
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Detailed Description | AIM OF THE STUDY Primary aim: • To evaluate the effectiveness of computer - controlled Intraligamentary Anaesthesia in eliminating pain during extraction of primary mandibular molars compared to Inferior Alveolar Nerve Block. Secondary aims:
PLAN OF THE STUDY Study design The study will be a two-arm randomized controlled clinical trial. It will be setup and reported according to the CONSORT guidelines. The PICOT question will be: do pediatric patients aged from 5-7 years (Population; P) assigned to receive CC-ILA (Intervention; I) in comparison to inferior alveolar nerve block conventional injection (Control; C) show less pain during injection and extraction of mandibular primary molars (outcome; O) in twenty-four hours (time; T)? Study setting and location Participants will be recruited from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Sample size estimation The sample size was calculated based on results obtained from previous studies of similar nature. Sample size was estimated assuming alpha error= 5% and study power= 80%. Tekin et al reported mean ± SD Sound, Eye and Motor (SEM) score = 3.93 ± 1.223 when intraligamentary anesthesia (ILA) was used, and 5.17 ± 1.891 when inferior alveolar nerve block (IANB) was used. Based on comparison of means, sample size was calculated to be 25 per group, and the total sample size required to compare the effectiveness of CC-ILA technique versus IANB during extraction of primary mandibular molars = number of groups × number per group= 2 x 25 = 50. The sample size was calculated using powerandsamplesize.com calculator. Randomization Participants complying with the inclusion criteria will be randomly assigned using a computer-generated list of random numbers. Allocation concealment Each child included in the study will be given a serial number that will be used in the allocation. These numbers will be written in identical sheets of paper with the group to which each child is allocated and placed inside opaque envelopes carrying the respective names of the children. A trial independent personnel will be assigned to the role of keeping the envelopes and unfolding them only at the time of the local anesthesia injection session so that the group the child is allocated to is concealed from the outcome evaluator. Grouping Participants will be randomly and equally allocated to one of the two arms.
Blinding 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. Examiner reliability
Clinical Procedure Preliminary screening visit • Full medical and dental history will be carried out to select patients. Those patients whose parents will give their consent to participate will be examined. Proper diagnosis with thorough clinical examination, and intraoral periapical radiograph of the tooth to be extracted will be taken to ensure that the patient will match the inclusion criteria. Patient Preparation • The child's dental visit will be a mean of introducing dentistry and acquainting the child to the dental unit and dental instruments using 'Tell Show Do' technique. No treatment will be done to the child in order to build a strong patient-dentist relationship. Intervention Visit Psychological child preparation:
Local Anaesthesia Administration
Follow up Following extraction, follow up after 24-hours will be planned via telephone calls to assess any adverse events. ETHICAL CONSIDERATIONS The study will be conducted following the ethical principles for medical research involving human subjects in Declaration of Helsinki. Ethical approval will be obtained from the Research Ethics Committee, Faculty of Dentistry, Alexandria University before commencing the study. The objectives, risks and benefits of the study will be explained to parents/ guardians and a signed informed consent will be obtained prior to treatment. Verbal consent will be obtained from the children before the intervention. Parents and children will be given age-appropriate oral hygiene instructions including proper teeth brushing twice a day especially before bedtime, as well as flossing if indicated. These measures will be demonstrated on a model. A fluoridated toothpaste and a brush will be provided to each participant on the day of the treatment. All needed treatment will be provided to the child including any restorations, space maintainers and fluoride application. Post extraction instructions will be explained well to the parents and patients to ensure good wound healing. All the possible clinical and/or adverse outcomes will be explained to the parents and they will be asked to report immediately if any of them occurs. |
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Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||
Study Design ICMJE | 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).
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
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Condition ICMJE | Local Anaesthetic Drug Adverse Reaction | ||||||||||||||||
Intervention ICMJE | 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
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||
Actual Enrollment ICMJE |
50 | ||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||
Actual Study Completion Date ICMJE | October 1, 2021 | ||||||||||||||||
Actual Primary Completion Date | August 12, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 5 Years to 7 Years (Child) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Listed Location Countries ICMJE | Egypt | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT04739735 | ||||||||||||||||
Other Study ID Numbers ICMJE | 00010556 - 0008839 | ||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Rodaina Helmy, Alexandria University | ||||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||||
Current Study Sponsor ICMJE | Alexandria University | ||||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||
Investigators ICMJE |
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PRS Account | Alexandria University | ||||||||||||||||
Verification Date | November 2021 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |