the Objective of This Research is to Compare the Clinical Effectiveness of the Conventional Lingual Arch Space Maintainers With Three-dimensional Printed Space Maintainers.
Comparative Evaluation of the Conventional and Three-Dimensional Printed Lower Lingual Arch Space Maintainers A Randomized Clinical Trial
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Introduction and Review of literature Primary teeth serve to preserve inborn space until permanent teeth erupt, in addition they help with speech and mastication. It is appropriate to highlight the primary dentition's function as the best space maintainer for permanent teeth. It is possible that premature primary tooth loss will cause undesirable primary and permanent tooth movements, including a loss in arch length. If there is not enough arch length, it is more likely to predict malocclusions such as crowding and ectopic eruption as well as tooth impaction.
Since the largest space loss occurs within a month of losing the deciduous teeth, it is best to use a space maintainer as soon as possible after early tooth loss. Space maintainers are the orthodontic appliance of choice for preventing space loss because they preserve space within the oral cavity.
Conventional space maintainers have significant drawbacks despite their clinical effectiveness. These include the need for patient compliance, extended chairside times, multiple steps in the fabrication process, technique-sensitive impressions and lab procedures, solder failure, and caries formation at band margins.
These disadvantages in the conventional space maintainer recommend the need for more advanced appliance designs and materials, one of which is three-dimensional (3D) printing, The process involves creating 3D objects using a digitally scanned and layered design of the entire object. The design is preserved using a "Standard Tessellation Language" (STL) file.
So, the objective of this research is to compare the clinical effectiveness of the conventional lingual arch space maintainers with three-dimensional printed space maintainers.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Reham M. Assistant Professor, PhD
- Telefonnummer: +966545318171
- E-post: reham_mohamed@dent.suez.edu.eg
Studer Kontakt Backup
- Navn: Rim M. Lecturer, PhD
- Telefonnummer: +201222726567
- E-post: rim_fathalla@dent.suez.edu.eg
Studiesteder
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Ismailia Governorate
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Ismailia, Ismailia Governorate, Egypt, 41522
- Rekruttering
- Suez Canal University
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Ta kontakt med:
- Reham M. Principle investigator, Assistant professor
- Telefonnummer: 0545318171
- E-post: reham_mohamed@dent.suez.edu.eg
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Ta kontakt med:
- Rim M. Co-investigator, Lecturer
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Apparently, healthy cooperative children have recently prematurely loss of more than one mandibular primary molar in any of the quadrants, full erupted mandibular first permanent molars in both sides, and whose lower permanent incisors have erupted
- The permanent successors of the lost primary molars were not expected to erupt within 6 months
- Angle's class 1 occlusion with normal primary molar relation
- Caries-free and periodontally healthy abutment teeth
- Absence of parafunctional habits or abnormal occlusion conditions such as crossbite, open bite, or deep bite.
- Children's age ranges from 7 to 9 years-old
- Radiographically, presence of permanent successors, more than one millimeter of bone covering the successor tooth germ, and/or only about one-third of the root of the permanent tooth has been formed.
- Parents and children were accepting the new treatment modality.
Exclusion Criteria:
- children exhibited poor oral hygiene, para-functional oral habits, severe crowding, space loss, and abnormal occlusion
- Extraction of primary molars exceeding three months.
- Radiographically, absence of permanent successor.
- uncooperative children
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Group I
Conventional spacemaintainer
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Two bands will be selected and checked for fit and adaptation around the distal abutment teeth, then an alginate impression will be taken and will be sent to the laboratory for fabrication
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Eksperimentell: Group II
3D printed spacemaintainer
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An intraoral scan for the patients' lower arch will be taken using a 3D digital dental scanner.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Patient satisfaction and pain experienced using the Wong-Baker Faces Test
Tidsramme: 9 months
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Patient satisfaction and pain experienced during conventional and digital impression and cementation will be evaluated using the Wong-Baker Faces test and subsequently recorded for clinical satisfaction at 3 months, 6 months and 9 months for both patient groups to evaluate appliance acceptance and convenience for the patients.
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9 months
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Gingival health will be evaluated using Sillness and Loe Gingival Index
Tidsramme: 9 months
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gingival health will be evaluated by Sillness and Loe Gingival Index Evaluation of the gingival health according to the (GI) described by (Loe and Silness, 1963): Score Criteria for the Gingival Index 0 No inflammation.
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9 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Impression taking experience for the patient assessed by 6-questions survey
Tidsramme: Day 1
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Questions Answer by Yes (√) or (No) ×
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Day 1
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Samarbeidspartnere og etterforskere
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Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 930/2024
- Organization's Unique Protocol (930/2024)
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