Molar-Incisor HypomineralizationNCT07268157
Evaluation of Different Anesthesias in Children With Molar Incisor Hypomineralization
An observational study of Molar-Incisor Hypomineralization, run by Canan Bayraktar Nahir at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar-Incisor Hypomineralization
- What is being tested?
- Conventional injection technique
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2024to 5 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 6-12 years old who apply to Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pedodontics.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanapaş University
Tokat Province, Tokat Province, 60100
About this study
Official title: 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.
Read the 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
- Being tested
- Computer-controlled anesthesia device (SleeperOne), Conventional injection technique
- Keywords
- Pain, Anxiety, Computer-Controlled Local Anesthesia, Molar Incisor Hypomineralization, Pediatric Dentistry
- Medical subject headings
- Molar Hypomineralization, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-controlled anesthesia device (SleeperOne)Device
Intraosseous anesthesia administered with the computer-controlled anesthesia device (SleeperOne)
Conventional injection techniqueProcedure or surgery
Anesthesia administered using the conventional injection technique
| Study group | Role | What they receive |
|---|---|---|
| Maxilla | maxillary 1st molar Receives: Device: Computer-controlled anesthesia device (SleeperOne); Procedure: Conventional injection technique | |
| Mandible | mandibular 1st molar Receives: Device: Computer-controlled anesthesia device (SleeperOne); Procedure: Conventional injection technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start5 Feb 2024
- Primary completion5 Feb 2025
- Study completion5 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Molar-Incisor HypomineralizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canan Bayraktar Nahir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Canan Bayraktar Nahir, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268157
- Sponsor's protocol ID
- 23-KAEK-205
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: with the link to be prepared later
Publications
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.
PubMed 30883951Gunaydin B, Bayraktar Nahir C, Sahin ND. Evaluation of the Effects of Computer-Controlled and Conventional Local Anesthesia on Pain and Anxiety in Children With Molar Incisor Hypomineralization: A Split-Mouth Study. Int J Paediatr Dent. 2026 Jul 19. doi: 10.1111/ipd.70129. Online ahead of print.
PubMed 42473055
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Computer-Controlled and Traditional Local Anesthesia on Pain and Anxiety in Children With Molar Incisor Hypomineralization
- ClinicalTrials.gov ID
- NCT07268157
- Acronym / sponsor ID
- 23-KAEK-205
- Conditions
- Molar-Incisor Hypomineralization
- Keywords
- Pain, Anxiety, Computer-Controlled Local Anesthesia, Molar Incisor Hypomineralization, Pediatric Dentistry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Canan Bayraktar NahirUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Apr 2025 (actual)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maxilla | – | Device: Computer-controlled anesthesia device (SleeperOne), Procedure: Conventional injection techniquemaxillary 1st molar |
| Mandible | – | Device: Computer-controlled anesthesia device (SleeperOne), Procedure: Conventional injection techniquemandibular 1st molar |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 6-12 years old who apply to Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pedodontics.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-controlled anesthesia device (SleeperOne)Intraosseous anesthesia administered with the computer-controlled anesthesia device (SleeperOne) | Device | Mandible, Maxilla |
| Conventional injection techniqueAnesthesia administered using the conventional injection technique | Procedure or surgery | Mandible, Maxilla |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Results publication: PubMed 30883951Smail-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.
- Derived from this study: PubMed 42473055Gunaydin B, Bayraktar Nahir C, Sahin ND. Evaluation of the Effects of Computer-Controlled and Conventional Local Anesthesia on Pain and Anxiety in Children With Molar Incisor Hypomineralization: A Split-Mouth Study. Int J Paediatr Dent. 2026 Jul 19. doi: 10.1111/ipd.70129. Online ahead of print.
- 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 trialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. with the link to be prepared later
Related trials for Molar-Incisor Hypomineralization
Active, not recruiting
Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment
Molar Incisor Hypomineralization
Not yet recruiting
Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
Molar-Incisor Hypomineralization (MIH)
Recruiting
Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
Fluoride Varnishes, Molar Incisor Hypomineralisation
Recruiting
Molar-Incisor Hypomineralization and Resin Infiltration
Molar Incisor Hypomineralization
Active, not recruiting
Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization
Molar Incisor Hypomineralisation, Irreversible Pulpitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Molar-Incisor Hypomineralization, run by Canan Bayraktar Nahir at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the effect of different anesthesia on pain in teeth with MIH (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07268157, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.