The use of computerized anesthesia in children suffering from an enamel defect that presents as discoloration of the first molars

Evaluation of the effectiveness, pain and complications of computerized intraosseous anesthesia in comparison to inferior alveolar nerve block to anesthetize permanent lower first molars with molar incisor hypomineralization in children

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14231094

Enrollment

Registered

2022-07-15

Start date

2022-07-25

Completion date

Unknown

Last updated

2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthetizing permanent molar incisor hypomineralization molars in children Oral Health

Interventions

This study is designed to compare two types of dental local anesthesia in children

the intervention type will be QuickSleeper 5 (QS) and the control one will be an active control with an inferior alveolar nerve block (IANB). The study will include 40 participants aged between 6-8 ye

Group 1: starts the first session with QS and the second session with IANB and Group 2: starts the first session with IANB and the second session with QS. A random allocation list will be carried out

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy children who don't suffer from any systemic disease 2. Children aged between 6 - 8 years 3. Children who need bilateral vital pulpotomy for mandibular first permanent molars with MIH. 4. Cooperative children who are classified as definitely positive according to Frankel

Exclusion criteria

Exclusion criteria: 1. The existence of any chronic or acute infection in the area of injection 2. Children who have taken any analgesics in the last two days before the anesthesia 3. Children who have allergy to amide type of anesthetic solutions. 4. Children who are contraindicated to lidocaine injection (who suffer from liver cirrhosis, hepatitis) 5. Children who are contraindicated to vasoconstrictors injection (who suffer from hypertension, myocardial infarction, angina pectoris) 6. Children who do not show cooperation during the procedure

Design outcomes

Primary

Measure	Time frame
Effectiveness of both techniques of anesthesia will be studied during the pulp treatment procedure assessed by measuring the pain caused by the anesthesia using both a subjective method (Simplified Faces Pain Scale S-FPS) while getting access to the tooth immediately after the injection and an objective method (Face – Legs – Activity – Cry – Consolability scale FLACC) during the excavation of coronal pulp during the injection	—

Measure

Time frame

Effectiveness of both techniques of anesthesia will be studied during the pulp treatment procedure assessed by measuring the pain caused by the anesthesia using both a subjective method (Simplified Faces Pain Scale S-FPS) while getting access to the tooth immediately after the injection and an objective method (Face – Legs – Activity – Cry – Consolability scale FLACC) during the excavation of coronal pulp during the injection

—

Secondary

Measure	Time frame
Parental satisfaction will be measured using a bespoke questionnaire 1 week after treatment	—

Countries

Syria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026