Chewing Pattern Changes Before and After Space Maintainer Placement in Children
14. september 2026 oppdatert av: Marmara University
Evaluation of Changes in Chewing Pattern in Children Before and After Space Maintainer Placement
This prospective observational study aims to evaluate changes in chewing patterns and chewing performance in children before and after placement of a unilateral fixed band-and-loop space maintainer.
Children aged 6-10 years who require a space maintainer as part of routine clinical care will be evaluated before appliance placement and again four weeks after placement.
Chewing pattern will be assessed by observing the preferred chewing side during standardized chewing trials, and chewing performance will be evaluated using a two-color chewing gum test scored with the Orophys Subjective Assessment Scale.
No additional invasive procedure will be performed for research purposes; the space maintainer treatment will be provided as part of routine clinical care.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
102
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: afra savas
- Telefonnummer: 90 5343279274
- E-post: aafranursavas@gmail.com
Studiesteder
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Maltepe
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Istanbul, Maltepe, Tyrkia (Türkiye)
- Marmara University
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Ta kontakt med:
- savas
- Telefonnummer: 90 5343279274
- E-post: aafranursavas@gmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
N/A
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Children aged 6-10 years attending the Department of Pediatric Dentistry at Marmara University Faculty of Dentistry who have premature loss of a primary molar and a clinical indication for a unilateral fixed band-and-loop space maintainer.
Eligible children will be recruited prospectively from patients scheduled to receive space maintainer treatment as part of routine clinical care.
Beskrivelse
Inclusion Criteria:
- Children aged 6-10 years. Premature loss or extraction of a primary molar in the maxilla or mandible with a clinical indication for a unilateral fixed band-and-loop space maintainer.
The abutment tooth for the space maintainer is vital and either sound or appropriately restored.
Complete dentition on the contralateral side of the arch to allow reliable assessment of chewing function.
No systemic condition affecting chewing function. Written informed consent provided by a parent or legal guardian; children aged 9 years and older also provide written assent.
Exclusion Criteria:Severe developmental delay, severe behavioral problems, or neuromuscular disorders that may directly affect chewing function, muscle activity, or treatment cooperation.
Temporomandibular joint disorder. Current orthodontic treatment. Anterior or posterior crossbite, open bite, or other skeletal/dental malocclusions that may affect chewing function.
Additional missing teeth in the contralateral arch, including hypodontia. Craniofacial anomalies, including cleft lip/palate syndromes. Systemic conditions requiring special medical precautions or antibiotic prophylaxis during routine dental treatment. -
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Children Receiving a Unilateral Band-and-Loop Space Maintainer
Children aged 6-10 years with premature loss of a primary molar and a clinical indication for a unilateral fixed band-and-loop space maintainer.
Chewing pattern and chewing performance will be assessed before space maintainer placement and again four weeks after placement.
|
A unilateral fixed band-and-loop space maintainer will be placed as part of routine clinical care following premature loss of a primary molar.
The appliance will be cemented to the abutment tooth with glass ionomer cement, and occlusion will be checked after placement.
The space maintainer is not assigned for research purposes; it is clinically indicated before study enrollment.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Masticatory Performance
Tidsramme: Baseline and 4 weeks after space maintainer placement
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Change in masticatory performance from before space maintainer placement to 4 weeks after placement, assessed using a two-color chewing gum test.
After 20 chewing cycles, color mixing will be scored using the Orophys Subjective Assessment Scale from SA1 to SA5, with higher scores indicating more complete color mixing and better masticatory performance.
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Baseline and 4 weeks after space maintainer placement
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Change in Chewing Pattern
Tidsramme: Baseline and 4 weeks after space maintainer placement
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Change in chewing pattern from before space maintainer placement to 4 weeks after placement.
The dominant chewing side (right/left) will be observed during seven standardized chewing trials.
Children using the same side in at least four of seven trials will be classified as unilateral chewers; those showing side alternation will be classified as bilateral chewers.
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Baseline and 4 weeks after space maintainer placement
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
20. september 2026
Primær fullføring (Antatt)
20. desember 2026
Studiet fullført (Antatt)
30. desember 2026
Datoer for studieregistrering
Først innsendt
14. september 2026
Først innsendt som oppfylte QC-kriteriene
14. september 2026
Først lagt ut (Faktiske)
18. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- chewing.p
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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