Molar Incisor Hypomineralization
Conditions
Keywords
Digital intraosseous anesthesia, Pediatric dentistry, Permanent molars, Dental pain, Dental anxiety
Brief summary
This multicentre, randomized clinical trial compared digital intraosseous anaesthesia with conventional local anaesthetic techniques in children aged 6-12 years receiving restorative treatment for MIH-affected permanent first molars. Within the maxillary stratum, digital intraosseous anaesthesia was compared with conventional infiltration anaesthesia; within the mandibular stratum, it was compared with inferior alveolar nerve block. The primary outcome was child-reported pain during restorative treatment. Secondary outcomes included pain during needle penetration and anaesthetic solution delivery, observed pain-related behaviour, and change in dental anxiety.
Detailed description
Children with an MIH-affected permanent first molar requiring restorative treatment were randomized separately within the maxillary and mandibular strata. In the maxillary stratum, digital intraosseous anaesthesia was compared with conventional infiltration anaesthesia. In the mandibular stratum, digital intraosseous anaesthesia was compared with conventional inferior alveolar nerve block. Only one MIH-affected permanent first molar was included for each child. Pain during needle penetration, anaesthetic solution delivery, and restorative treatment was assessed using the Wong-Baker FACES Pain Rating Scale. Pain-related behavioural responses were assessed using the Face, Legs, Activity, Cry, Consolability scale, and dental anxiety was assessed before and after local anaesthetic administration using the Modified Child Dental Anxiety Scale.
Interventions
DEVICESleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System
Digital intraosseous anaesthesia was administered using the SleeperOne 5 computer-controlled system (Dental Hi Tec, Cholet, France). Initial mucosal anaesthesia was achieved using 0.1-0.2 mL of 4% articaine with 1:200,000 epinephrine, followed by intraosseous administration of an additional 1 mL of the same anaesthetic solution at the device-controlled slow flow rate.
PROCEDUREConventional Maxillary Infiltration Anaesthesia
Supraperiosteal infiltration anaesthesia was performed using a standard aspirating dental syringe and a 27-gauge short needle. One millilitre of 4% articaine with 1:200,000 epinephrine was deposited slowly into the buccal sulcus adjacent to the MIH-affected maxillary permanent first molar.
PROCEDUREConventional Inferior Alveolar Nerve Block Anaesthesia
Inferior alveolar nerve block anaesthesia was administered using a standard aspirating dental syringe and a 27-gauge long needle. One millilitre of 4% articaine with 1:200,000 epinephrine was deposited slowly. Adequate anaesthesia was confirmed by patient-reported lip numbness before restorative treatment was started.
Sponsors
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 6-12 years. * Confirmed diagnosis of molar-incisor hypomineralisation according to the European Academy of Paediatric Dentistry diagnostic criteria. * Presence of an MIH-affected permanent first molar classified as Würzburg Category 1 or 2a and requiring either a direct resin composite restoration or a stainless steel crown. * Positive or definitely positive behaviour according to the Frankl Behaviour Rating Scale. * No known allergy to local anaesthetics. * No relevant systemic disease.
Exclusion criteria
* Receipt of analgesic, anxiolytic, or sedative medication within 48 hours before the treatment appointment. * Previous experience with intraosseous anaesthesia. * Presence of an acute dentoalveolar infection at the planned treatment site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child-Reported Pain During Dental Treatment Assessed Using the Wong-Baker FACES Pain Rating Scale | During the restorative procedure after local anesthesia administration, within the single treatment visit | Children rated the pain experienced during the restorative procedure using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child-Reported Pain During Needle Penetration Assessed Using the Wong-Baker FACES Pain Rating Scale | At the time of needle insertion into the oral mucosa, immediately before delivery of the local anaesthetic solution, during the single treatment visit | Children rated the pain experienced during needle penetration using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. |
| Child-Reported Pain During Local Anaesthetic Solution Delivery Assessed Using the Wong-Baker FACES Pain Rating Scale | During delivery of the local anaesthetic solution, immediately after needle penetration, during the single treatment visit | Children rated the pain experienced during delivery of the local anaesthetic solution using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. |
| Observer-Rated Pain-Related Behaviour During Local Anaesthetic Administration Assessed Using the FLACC Scale | During the local anaesthetic injection sequence, from needle penetration through completion of anaesthetic solution delivery, before commencement of the restorative procedure, during the single treatment visit | Pain-related behaviour was independently assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. Each of the five components is scored from 0 to 2, producing a total score ranging from 0 to 10. A total score of 0 indicates a relaxed and comfortable child, 1-3 indicates mild discomfort, 4-6 indicates moderate pain, and 7-10 indicates severe pain. Higher scores indicate greater pain-related behavioural responses. |
| Change in Dental Anxiety From Before to After Local Anaesthetic Administration Assessed Using the Modified Child Dental Anxiety Scale | Immediately before and immediately after local anaesthetic administration, during the single treatment visit | Dental anxiety was assessed using the eight-item Modified Child Dental Anxiety Scale (MCDAS). Each item is scored from 1 (relaxed) to 5 (extremely anxious), producing a total score ranging from 8 to 40. Higher total scores indicate greater dental anxiety. Change was calculated as the post-anaesthesia score minus the pre-anaesthesia score; negative values indicate a reduction in dental anxiety. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORAlp Abidin Atesci, PhD
Istanbul Beykent University
Outcome results
None listed