- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07589179
Evaluation of Occlusal Force and Masticatory Function in Children With Molar-Incisor Hypomineralization
Evaluation of Occlusal Force Distribution and Masticatory Function Before and After Restorative Treatment in Children With Molar-Incisor Hypomineralization
This study aims to evaluate right-left chewing balance and masticatory function in children with Molar-Incisor Hypomineralization (MIH) before and after restorative treatment. MIH is a developmental enamel defect that may cause tooth sensitivity, discomfort during chewing, and functional asymmetry.
Children aged 7 to 12 years with bilateral MIH affecting the first permanent molars will receive glass hybrid restorative treatment. Right-left occlusal force distribution will be assessed using a digital occlusal analysis system. In addition, chewing side preference and chewing balance will be evaluated using a standardized chewing gum protocol. These two assessment methods will be used together to provide complementary information about masticatory function.
Measurements will be performed before treatment and during follow-up visits after treatment. The findings obtained from children with MIH will also be compared with healthy children without MIH. The study aims to determine whether restorative treatment improves chewing balance and functional oral performance in children with MIH.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Afra Nur Savas
- Telefonnummer: +90 534 327 92 74
- E-post: aafranursavas@gmail.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Children aged 7 to 12 years
- Presence of bilateral molar-incisor hypomineralization (MIH) affecting first permanent molars
- Need for restorative treatment in MIH-affected molars
- Cooperative children with sufficient cognitive ability to complete functional assessments
- Presence of healthy control participants without MIH for comparison
- Mixed dentition period
- Signed informed consent obtained from parents or legal guardians
Exclusion Criteria:
- Temporomandibular disorders or orofacial pain
- Systemic diseases or regular medication use affecting mastication
- History of orthodontic treatment or parafunctional habits
- Craniofacial anomalies or developmental dental anomalies
- Extensive prosthetic restorations affecting chewing function
- Uncooperative children unable to complete examination procedures
- Acute dental infection or pain requiring emergency treatment
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: MIH Restorative Treatment Group
Children with molar-incisor hypomineralization (MIH) will receive glass hybrid restorative treatment.
Occlusal force distribution and chewing function will be evaluated before and after treatment using digital occlusal analysis and a chewing gum protocol.
|
Restorative treatment of MIH-affected molars using glass hybrid restorative material to evaluate changes in occlusal force distribution and chewing function.
|
|
Inget ingripande: Healthy Control Group
Healthy children without MIH will undergo occlusal force distribution and chewing function assessments for comparison with the MIH group.
No restorative intervention will be performed.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Occlusal Force Distribution Between Right and Left Sides
Tidsram: Baseline and 3 months after restorative treatment
|
Percentage distribution of occlusal force between the right and left sides and chewing side assessed using a chewing gum test will be evaluated before and after restorative treatment in children with MIH using a digital occlusal analysis system.
|
Baseline and 3 months after restorative treatment
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- pedo-TO
- 09.2024.806 (Annan identifierare: Marmara University Faculty of Medicine Non-Drug and Non-Medical Device Clinical Research Ethics Committee)
Plan för individuella deltagardata (IPD)
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