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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Reham M. Assistant Professor, PhD
- Numero di telefono: +966545318171
- Email: reham_mohamed@dent.suez.edu.eg
Backup dei contatti dello studio
- Nome: Rim M. Lecturer, PhD
- Numero di telefono: +201222726567
- Email: rim_fathalla@dent.suez.edu.eg
Luoghi di studio
-
-
Ismailia Governorate
-
Ismailia, Ismailia Governorate, Egitto, 41522
- Reclutamento
- Suez Canal University
-
Contatto:
- Reham M. Principle investigator, Assistant professor
- Numero di telefono: 0545318171
- Email: reham_mohamed@dent.suez.edu.eg
-
Contatto:
- Rim M. Co-investigator, Lecturer
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Group I
Conventional spacemaintainer
|
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
|
|
Sperimentale: Group II
3D printed spacemaintainer
|
An intraoral scan for the patients' lower arch will be taken using a 3D digital dental scanner.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Patient satisfaction and pain experienced using the Wong-Baker Faces Test
Lasso di tempo: 9 months
|
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.
|
9 months
|
|
Gingival health will be evaluated using Sillness and Loe Gingival Index
Lasso di tempo: 9 months
|
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.
|
9 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Impression taking experience for the patient assessed by 6-questions survey
Lasso di tempo: Day 1
|
Questions Answer by Yes (√) or (No) ×
|
Day 1
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 930/2024
- Organization's Unique Protocol (930/2024)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .