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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Reham M. Assistant Professor, PhD
- Telefonnummer: +966545318171
- E-mail: reham_mohamed@dent.suez.edu.eg
Undersøgelse Kontakt Backup
- Navn: Rim M. Lecturer, PhD
- Telefonnummer: +201222726567
- E-mail: rim_fathalla@dent.suez.edu.eg
Studiesteder
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Ismailia Governorate
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Ismailia, Ismailia Governorate, Egypten, 41522
- Rekruttering
- Suez Canal University
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Kontakt:
- Reham M. Principle investigator, Assistant professor
- Telefonnummer: 0545318171
- E-mail: reham_mohamed@dent.suez.edu.eg
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Kontakt:
- Rim M. Co-investigator, Lecturer
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde 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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Impression taking experience for the patient assessed by 6-questions survey
Tidsramme: Day 1
|
Questions Answer by Yes (√) or (No) ×
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Day 1
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 930/2024
- Organization's Unique Protocol (930/2024)
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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