An interventional study of Computer-Controlled Local Anesthesia and Conventional Local Anesthesia in Molar-Incisor Hypomineralization, Molar-Incisor Hypomineralization (MIH) and Computer-Controlled Local Anesthesia, sponsored by Marmara University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Marmara University · Not applicable, Interventional, and Treatment
Among 34 studies in Molar Hypomineralization with a site in Turkey — 7 open to participants now, 10 under way, none of them phase 3. Molar Hypomineralization · Turkey.
Among the 34 studies in Molar Hypomineralization with a site in Turkey, this one is the 12th largest by planned enrollment of the 26 interventional ones, is one of 7 that started in 2026, is one of 26 with no phase, and was the 30th registered.
133 studies on the registry are indexed under Molar Hypomineralization; 46 are open to participants now.
This study's planned enrollment of 54 is close to the median of 53 across 104 interventional studies indexed under Molar Hypomineralization.
Browse Molar Hypomineralization studies →7 of the 34 studies in Molar Hypomineralization with a site in Turkey are open now, in 1 country. Each count lists the studies.
Of the 15 Molar Hypomineralization studies recruiting now, 0 (0%) set no upper age limit and 15 (100%) stop at 75 or younger; 15 take children under 18; 10 take healthy volunteers.
This study: 8 Years to 12 Years · all sexes · healthy volunteers too.
The full table on the hub →34 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 7 started in 2026.
Median enrollment 52 across the 26 interventional studies, 88 across the 8 observational. Of the 23 that completed or were terminated, 0 (0%) have results posted.
None of the 34 has an industry lead sponsor. The 10 most frequent:
Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
Marmara University has 9 studies filed under Molar Hypomineralization — fewer than ten, so there is no comparison to draw.
4 of the studies in Molar Hypomineralization with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07352813Ankara Yildirim Beyazıt UniversityIntraosseous vs Infiltration Anesthesia in Molar-Incisor Hypomineralization (MIH) Children | 2026-11-07 |
| NCT07469124Inonu UniversityClinical Evaluation of Resin Infiltration Treatment of MIH-affected Teeth in Pediatric Patients | 2027-01-31 |
| NCT07733011Marmara UniversityComparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization | 2027-08-25 |
| NCT07701642Marmara UniversityAssessment of Peridontal Inflamatuar Markers in MIH | 2027-08-25 |
Among the 34 studies in Molar Hypomineralization with a site in Turkey, from their registry updates:
The main questions this study aims to answer are:
Does computer-controlled local anesthesia cause less pain and anxiety than conventional local anesthesia in children with molar-incisor hypomineralization (MIH)?
Is there a difference between the two methods in anesthesia onset time, injection duration, physiological responses, and the need for additional anesthesia?
Researchers will compare computer-controlled and conventional local anesthesia in children aged 8-12 years with MIH. Each child will receive both anesthesia methods during separate dental visits, on comparable permanent molar teeth, to determine which method is more comfortable, effective, and preferred by children.
This randomized split-mouth clinical trial will compare computer-controlled local anesthesia with conventional local anesthesia in children aged 8-12 years with molar-incisor hypomineralization (MIH).
Each child will receive both anesthesia methods during separate restorative treatment visits on comparable affected permanent molars. Pain will be evaluated using child-reported and behavioral pain scales. Dental anxiety, heart rate, oxygen saturation, anesthesia onset time, injection duration, need for additional anesthesia, and patient preference will also be assessed.
The study aims to determine whether computer-controlled local anesthesia provides a more comfortable and effective option than conventional anesthesia for children with MIH.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Local anesthesia will be administered using the SleeperOne computer-controlled local anesthetic delivery system according to the manufacturer's pediatric protocol. The device electronically controls the injection flow rate and pressure. A 4% articaine solution with 1:100,000 epinephrine will be used before restorative treatment of the MIH-affected permanent molar.
Device: Computer-Controlled Local Anesthesia
Local anesthesia will be administered using a conventional dental syringe. Buccal infiltration will be used for maxillary teeth, and an inferior alveolar nerve block will be used for mandibular teeth. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.
Procedure: Conventional Local Anesthesia
Local anesthesia will be administered using the SleeperOne computer-controlled local anesthetic delivery system according to the manufacturer's pediatric protocol. The device electronically controls the flow rate and pressure of the anesthetic solution. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.
Also known as: SleeperOne, Digital Anesthesia
Local anesthesia will be administered using a conventional dental syringe. Buccal infiltration will be used for maxillary teeth, and an inferior alveolar nerve block will be used for mandibular teeth. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.
Also known as: Traditional Local Anesthesia
Injection pain assessed using the Wong-Baker Faces Pain Rating Scale
Pain intensity will be assessed during local anesthetic injection using the Wong-Baker Faces Pain Rating Scale (score range: 0-10; higher scores indicate greater pain).
Time frame: Immediately after completion of local anesthetic injection at each treatment visit
Injection pain assessed using the Visual Analog Scale (VAS)
Pain intensity will be assessed immediately after local anesthetic injection using a 100-mm Visual Analog Scale (0=no pain, 100=worst imaginable pain; higher scores indicate greater pain).
Time frame: Immediately after completion of local anesthetic injection at each treatment visit
Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Behavioral pain will be assessed during local anesthetic injection using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale (score range: 0-10; higher scores indicate greater pain).
Time frame: Periprocedural (during local anesthetic injection at each treatment visit)
Successful local anesthesia during restorative treatment
Successful local anesthesia will be defined as completion of cavity preparation and restorative treatment without the need for supplemental local anesthesia and without interruption of treatment because of pain. The outcome will be reported as the percentage of treatment visits with successful local anesthesia.
Time frame: Immediately after completion of restorative treatment at each treatment visit
Absence of response to electric pulp testing
The proportion of treatment visits in which no response is obtained using an electric pulp tester after local anesthetic administration.
Time frame: Immediately after completion of local anesthetic injection at each treatment visit
Anesthesia Onset Time
Anesthesia onset time will be compared between computer-controlled and conventional local anesthesia. It will be defined as the time from completion of the injection until the child reports numbness and no response is obtained with electric pulp testing. The time will be recorded in seconds.
Time frame: Immediately following local anesthetic injection at each treatment visit.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.
Of 62 non-industry interventional studies with no phase under Molar Hypomineralization, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 25. This study's planned 12 months is below that.
Counting every sponsor, half of 62 studies reached it within 14 months; a quarter within 8 and three quarters within 25.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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