Public trial
RBR-7dqyscg Use of computerized anesthesia in children during dental care: A randomized clinical trial to assess anxiety and pain pe...
Date of registration: 08/05/2022 (mm/dd/yyyy)Last approval date : 04/21/2025 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
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Use of computerized anesthesia in children's anxiety and pain perception during dental care: Randomized Clinical Trial
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Uso de anestesia computadorizada na ansiedade e percepção de dor de crianças durante atendimento odontológico: Ensaio Clínico Randomizado
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Use of computerized anesthesia in children's anxiety and pain perception during dental care: Randomized Clinical Trial
Trial identification
- UTN code: U1111-1320-1434
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Public title:
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Use of computerized anesthesia in children during dental care: A randomized clinical trial to assess anxiety and pain perception
pt-br
Uso de anestesia computadorizada em crianças durante atendimento odontológico: Um ensaio clínico randomizado para avaliar ansiedade e percepção de dor
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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55874822.6.0000.5317
Issuing authority: Plataforma Brasil
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5.299.880
Issuing authority: Comitê de Ética em Pesquisa da Faculdade de Medicina da Universidade Federal de Pelotas
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55874822.6.0000.5317
Sponsors
- Primary sponsor: Universidade Federal de Pelotas
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Secondary sponsor:
- Institution: Universidade Federal de Pelotas
- Institution: Faculdade de Medicina da Universidade Federal de Pelotas
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Supporting source:
- Institution: Fundação de Amparo à pesquisa do estado do Rio Grande do Sul
Health conditions
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Health conditions:
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Anxiety
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Ansiedade
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General descriptors for health conditions:
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N01.400.535 Oral health
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N01.400.535 Saúde bucal
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Specific descriptors:
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F01.470.132 Anxiety
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F01.470.132 Ansiedade
Interventions
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Interventions:
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The purpose of this randomized clinical trial is to compare the use of computerized anesthesia with conventional local anesthesia during dental care in children. A sample will consist of 48 patients, divided into control and intervention groups. Patients will be randomly allocated to one of the experimental groups, 24 for each group. Intervention group will use computerized (administration of computerized using the Morphe device) and control group, conventional (conventional anesthesia may be local anesthesia with a traditional metal syringe). The children will be cared for by previously trained graduate students.
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O objetivo deste ensaio clínico randomizado é comparar o uso de anestesia computadorizada com anestesia local convencional durante o atendimento odontológico em crianças. A amostra será composta por 48 pacientes, divididos em grupos controle e intervenção. Os pacientes serão alocados aleatoriamente em um dos grupos experimentais, sendo 24 para cada grupo. Grupo intervenção utilizará anestesia computadorizada (administração de anestesia computadorizada usando o dispositivo Morpheus) e grupo controle, anestesia local convencional (a anestesia convencional será administrada com uma seringa de metal tradicional). As crianças serão atendidas por alunos de pós-graduação previamente treinados.
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Descriptors:
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E03.155 Anesthesia
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E03.155 Anestesia
Recruitment
- Study status: Recruiting
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Countries
- Brazil
- Date first enrollment: 07/01/2022 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 48 - 7 Y 11 Y -
Inclusion criteria:
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Children of both gender; between 7 and 11 years of age; good general health; need for dental treatment under local anesthesia
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Crianças de ambos os sexos; com idade entre 7 a 11 anos; com boa saúde geral; necessidade de tratamento dentário sob anestesia local
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Exclusion criteria:
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Children with physical disabilities that prevent the use of computerized anesthesia; mental disability
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Crianças com deficiência física que impeçam o uso da anestesia computadorizada; deficiência mental
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase 1 Other Parallel 2 Single-blind Randomized-controlled N/A
Outcomes
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Primary outcomes:
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Pain perception will be evaluated during the anesthetic injection in the dental treatment and after the dental treatment, through the instrument Face Legs Activity Cry and Consolability; and Faces Pain Scale-Revised.
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Percepção da dor será avaliada durante a injeção anestésica no tratamento odontológico e após o tratamento odontológico, através do instrumento FLACC (Face Legs Activity Cry and Consolability) e FPS-R (Faces Pain Scale-Revised).
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Secondary outcomes:
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The child's anxiety will be assessed during the anesthetic injection in the dental treatment and after the dental treatment. During the anesthetic injection, the heart rate will be measured (physiological measurement). After dental treatment, the state of anxiety will be evaluated through the Vemam Picture Test and divided into trait-anxiety and state-anxiety.
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Ansiedade da criança será avaliada durante a injeção anestésica no tratamento odontológico e após o tratamento odontológico. Durante a injeção anestésica será medida a frequência cardíaca (medida fisiológica). Após o tratamento odontológico, o estado de ansiedade será avaliado por meio da Venham Picture Test e dividas em ansiedade-traço e ansiedade-estado.
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The patient's level of cooperation will be assessed after the anesthetic injection during dental treatment. The child's behavior will be evaluated using the modified Vemm scale (scores from 0 to 5) where the highest scores indicate uncooperative behavior.
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Nível de cooperação do paciente será avaliado após a injeção anestésica durante o tratamento odontológico. O comportamento da criança será avaliado por meio da escala de Venham modificada (escores de 0 a 5) onde os maiores escores indicam comportamento não cooperativo.
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Dentist stress will be assessed with the Visual Analog Scale.
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Estresse do dentista será avaliado com a Escala Visual Analógica.
Summary Results
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Baseline char:
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The total sample of this study consisted of 19 children, aged 5 to 11 years, with a mean age of 8.5 years. Of the 19 participating children, 12 (63.2%) were female and 7 (36.8%) were male. The sample was randomized in a balanced manner, with 10 patients receiving conventional anesthesia and 9 undergoing computerized anesthesia. Among the anesthetic techniques used, only three children (15.8%) underwent inferior alveolar nerve block, while the majority (84.2%) received infiltrative anesthesia.
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Participants flow:
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Only one family refused to participate in the research, and only one participant, allocated to the Morpheus® group, was unable to complete the anesthesia or the proposed treatment, due to lack of cooperation.
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Adverse events:
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The risks involved in participation are only those inherent to dental treatment.
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Outcome measure:
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Regarding the satisfaction of the children who received computerized anesthesia, they were asked what they thought of "putting the tooth to sleep" and whether they would be willing to undergo the same technique again. Of the nine participants who used Morpheus®, six said they liked it, two did not like it and one did not know how to respond. Regarding the willingness to undergo anesthesia again, only one child said they would not be prepared (the same one who had not liked the experience), while the other eight were ready to repeat the procedure. The dentists were asked about their perception of the service through an open-ended question. All operators agreed that computerized anesthesia had a positive effect on their patients' perception of pain, and the majority (88.9%) responded that this device also has a better effect on anxiety.
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Results summary:
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This randomized clinical trial was conducted at a postgraduate clinic in Pelotas/RS, Brazil, between September 2023 and October 2024. Children aged 5 to 11 years, without systemic problems, who required dental treatment under local anesthesia were included. A total of 19 patients were randomly assigned to the following groups: 1) Control group - conventional carpule syringe or 2) Intervention group - computerized anesthesia, with the Morpheus® device, both preceded by topical anesthesia. The perception of children and operators was assessed at the end, and operators recorded their stress level on a visual analogue scale. Six of the nine children who used Morpheus® liked the technique and eight would be willing to use it again. Regarding operator stress, there was a significant reduction with the use of computerized anesthesia (p=0.026). The results suggest that computerized anesthesia can reduce operator stress and improve the patient experience, being a promising alternative to the conventional technique. Further studies are needed to validate these findings.
Data Sharing Plan
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Data Sharing Plan:
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No
Contacts
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Public contact
- Full name: Fernanda Vieira Almeida
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- Address: R. Gomes Carneiro, 01
- City: Pelotas / Brazil
- Zip code: 96010-610
- Phone: +55 (53) 3310-1801
- Email: fernanda.vieira.almeida1995@gmail.com
- Affiliation: Universidade Federal de Pelotas
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Scientific contact
- Full name: Fernanda Vieira Almeida
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- Address: R. Gomes Carneiro, 01
- City: Pelotas / Brazil
- Zip code: 96010-610
- Phone: +55 (53) 3310-1801
- Email: fernanda.vieira.almeida1995@gmail.com
- Affiliation: Universidade Federal de Pelotas
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Site contact
- Full name: Fernanda Vieira Almeida
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- Address: R. Gomes Carneiro, 01
- City: Pelotas / Brazil
- Zip code: 96010-610
- Phone: +55 (53) 3310-1801
- Email: fernanda.vieira.almeida1995@gmail.com
- Affiliation: Universidade Federal de Pelotas
Additional links:
Total de Ensaios Clínicos 18792.
Existem 9607 ensaios clínicos registrados.
Existem 5182 ensaios clínicos recrutando.
Existem 85 ensaios clínicos em análise.
Existem 6245 ensaios clínicos em rascunho.