Evaluation of Different Anesthesias in Children With Molar Incisor Hypomineralization

NCT ID: NCT07268157

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2025-04-05

Brief Summary

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.

Detailed 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.

Conditions

Molar-Incisor Hypomineralization

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Maxilla

maxillary 1st molar

Computer-controlled anesthesia device (SleeperOne)

Intervention Type: DEVICE

Intraosseous anesthesia administered with the computer-controlled anesthesia device (SleeperOne)

Conventional injection technique

Intervention Type: PROCEDURE

Anesthesia administered using the conventional injection technique

Mandible

mandibular 1st molar

Computer-controlled anesthesia device (SleeperOne)

Intervention Type: DEVICE

Intraosseous anesthesia administered with the computer-controlled anesthesia device (SleeperOne)

Conventional injection technique

Intervention Type: PROCEDURE

Anesthesia administered using the conventional injection technique

Interventions

Computer-controlled anesthesia device (SleeperOne)

Intraosseous anesthesia administered with the computer-controlled anesthesia device (SleeperOne)

Intervention Type: DEVICE

Conventional injection technique

Anesthesia administered using the conventional injection technique

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canan Bayraktar Nahir

OTHER

Sponsor Role: lead

Responsible Party

Canan Bayraktar Nahir

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tokat Gaziosmanapaş University

Tokat Province, Tokat Province, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Smail-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Evaluation of intraosseous computerized injection system (QuickSleeper) vs conventional infiltration anaesthesia in paediatric oral health care: A multicentre, single-blind, combined split-mouth and parallel-arm randomized controlled trial. Int J Paediatr Dent. 2019 Sep;29(5):573-584. doi: 10.1111/ipd.12494. Epub 2019 Apr 8.

Reference Type: RESULT

PMID: 30883951 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://pubmed.ncbi.nlm.nih.gov/30883951/

Evaluation of intraosseous computerized injection system (QuickSleeper™) vs conventional infiltration anaesthesia in paediatric oral health care: A multicentre, single-blind, combined split-mouth and parallel-arm randomized controlled trial

Other Identifiers

23-KAEK-205

Identifier Type: -

Identifier Source: org_study_id