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Evaluation of Different Anesthesias in Children With Molar Incisor Hypomineralization

C

Canan Bayraktar Nahir

Status

Completed

Conditions

Molar-Incisor Hypomineralization

Treatments

Procedure: Conventional injection technique
Device: Computer-controlled anesthesia device (SleeperOne)

Study type

Observational

Funder types

Other

Identifiers

NCT07268157
23-KAEK-205

Details and patient eligibility

About

In children with molar-incisor hypomineralization (MIH), insufficient depth of anesthesia can lead to increased anxiety and behavior management problems, which may negatively affect the quality of restorations. This situation has increased the need for modern techniques and devices to minimize pain during local anesthesia. The aim of this study was to compare the effects of the SleeperOne computer-controlled local anesthesia system and the conventional local anesthesia technique on pain and anxiety in children with MIH. The null hypothesis of the study stated that there would be no statistically significant difference between the effects of the two local anesthesia methods on pain and anxiety in children with MIH.

Full description

The study was conducted using a split-mouth design with 28 patients and 56 teeth who met the inclusion criteria and were recruited from the Department of Pediatric Dentistry, Faculty of Dentistry, Tokat Gaziosmanpaşa University. The patients included in the study were randomly assigned to two groups:

  • Control group: Anesthesia administered using the conventional injection technique.
  • Study group: Intraosseous anesthesia administered with the computer-controlled anesthesia device (SleeperOne).

Teeth affected by MIH were classified according to the Molar-Incisor Hypomineralization Treatment Need Index (MIH-TNI). Those in category 2 were evaluated as "Without hypersensitivity," while those in category 4 were assessed as "With hypersensitivity" Prior to the study, all participants completed the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). Pulse rate, oxygen saturation (SpO₂), and salivary cortisol levels were measured before local anesthesia, after anesthesia, and after treatment. In addition, the Wong-Baker FACES Pain Rating Scale (WBS), Visual Analogue Scale (VAS), and Face, Legs, Activity, Cry, Consolability Scale (FLACC) were used. The data were analyzed statistically.

Enrollment

28 patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Being between the ages of 6 and 12
  • Not having a systemic disease
  • Frankl Behavior Rating Scale score of 3 or 4
  • Presence of bilateral MIH in the lower or upper jaw permanent first molars
  • Deep dentinal caries in permanent 1st molars that can be treated with vital pulp treatments
  • No history of acute pain in the teeth planned to be included in the study

Exclusion criteria

  • Having a systemic disease
  • Allergy to the anesthetic to be used
  • Having an acute infection
  • Unilateral teeth with BAKH lesions and deep dentin caries
  • If they or their parents do not want to participate in the study
  • The teeth planned to be included in the study showed irreversible pulpitis symptoms
  • Among the patients planned to be included in the study; those who did not consent to anesthesia or treatment, those who did not come to their second appointment, and those who needed devital pulp treatments during the procedure

Trial design

28 participants in 2 patient groups

Maxilla
Description:
maxillary 1st molar
Treatment:
Device: Computer-controlled anesthesia device (SleeperOne)
Procedure: Conventional injection technique
Mandible
Description:
mandibular 1st molar
Treatment:
Device: Computer-controlled anesthesia device (SleeperOne)
Procedure: Conventional injection technique

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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