Evaluation of Different Anesthesias in Children With Molar Incisor Hypomineralization

NCT07268157 | Completed

• 1 other identifier: 23-KAEK-205
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Molar-Incisor Hypomineralization

Keywords

Pain; Anxiety; Computer-Controlled Local Anesthesia; Molar Incisor Hypomineralization; Pediatric Dentistry

Outcome Measures

Primary Outcomes (2)

• Evaluation of the effect of different anesthesia on pain in teeth with MIH

  VAS (Visual Analog Scale), WBS (Wong-Baker Facial Rating Scale for Pain) and FLACC (Face, Leg, Activity, Crying, Consolability Behavioral Pain Rating Scale) scales were used for pain assessment. In the VAS, patients were asked to select the number expressing the level of pain from a linear scale with numerical values between 0-10 (0 no pain, 10 excruciating pain). On the WBS scale, they were asked to choose one of six faces, with the happy face at 0 symbolizing "no pain" and the crying face at 5 symbolizing "the most pain". Both numerical (VAS) and visual (WBS) assessments were made. According to the scores obtained on the FLACC scale: 0 points indicated that the patient was relaxed and peaceful, 1 to 3 points indicated mild discomfort, 4 to 6 points indicated moderate pain and 7 to 10 points indicated severe pain.

  6 month

• Evaluation of the effect of different anesthesia on anxiety in teeth with MIH

  The Child Fear Rating Scale-Dental Subscale (CFSS-DS), a numerical scale, was used to assess anxiety in patients. According to the answers given in the CFSS-DS; a score between 15 and 75 is obtained. According to the score; it was accepted that children aged 15-38 years did not have dental anxiety, while children with a score of 38 and above were considered to have dental anxiety. Pulse rate, oxygen saturation and salivary cortisol measurements were used in an anxiety assessment.

  6 month

Study Arms (2)

Maxilla

maxillary 1st molar

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

Mandible

mandibular 1st molar

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

Interventions

Conventional injection technique PROCEDURE

Anesthesia administered using the conventional injection technique

Mandible; Maxilla

Computer-controlled anesthesia device (SleeperOne) DEVICE

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

Mandible; Maxilla

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 6-12 years old who apply to Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pedodontics.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canan Bayraktar Nahir: lead

Study Sites (1)

Tokat Gaziosmanapaş University

Tokat Province, Tokat Province, 60100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 30883951 RESULT

Related Links

• 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

MeSH Terms

Conditions

Molar Hypomineralization; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 5, 2025
• Study Start: February 5, 2024
• Primary Completion: February 5, 2025
• Study Completion: April 5, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

TU (1)