Evaluation of Different Anesthesias in Children With Molar Incisor Hypomineralization

December 3, 2025 updated by: Canan Bayraktar Nahir

Evaluation of the Effects of Computer-Controlled and Traditional Local Anesthesia on Pain and Anxiety in Children With Molar Incisor Hypomineralization

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Tokat Province
      • Tokat Province, Tokat Province, Turkey (Türkiye), 60100
        • Tokat Gaziosmanapaş University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Maxilla
maxillary 1st molar
Device: Computer-controlled anesthesia device (SleeperOne)
Intraosseous anesthesia administered with the computer-controlled anesthesia device (SleeperOne)
Procedure: Conventional injection technique
Anesthesia administered using the conventional injection technique
Mandible
mandibular 1st molar
Device: Computer-controlled anesthesia device (SleeperOne)
Intraosseous anesthesia administered with the computer-controlled anesthesia device (SleeperOne)
Procedure: Conventional injection technique
Anesthesia administered using the conventional injection technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the effect of different anesthesia on pain in teeth with MIH
Time Frame: 6 month
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
Time Frame: 6 month

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canan Bayraktar Nahir

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2024

Primary Completion (Actual)

February 5, 2025

Study Completion (Actual)

April 5, 2025

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-KAEK-205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

with the link to be prepared later

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Molar-Incisor Hypomineralization

Clinical Trials on Computer-controlled anesthesia device (SleeperOne)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe