- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07828431
Comparison of Bond Failure Rate of Orthodontic Brackets Bonded With V-Prep and Resin-Modified Glass Ionomer Cement Versus Conventional Acid-Etch Composite Resin
Comparison of Bond Failure Rate of Orthodontic Brackets Bonded With V-Prep and Resin-Modified Glass Ionomer Cement Versus Conventional Acid-Etch Composite Resin: A Split-Mouth Randomized Controlled Trial
Ethical approval will be obtained by the FUSH and informed consent will be obtained from individual patients/guardians in writing. Inclusion and exclusion criteria will be used to obtain random patient samples within the Orthodontic Department of FUCD&H and Baseline parameters like age, gender, O'Leary Plaque Score, malocclusion classification type and degree of overbite will be recorded. Patients will be screened one at a time if they are eligible. For this purpose, sequentially numbered, opaque sealed envelopes will be opened just before the bonding assignment for allocation concealment. Both orally and in writing to all patients. Tooth surfaces will be pumiced and standardized.
While, the Primer light-cured for 10-sec each item, the Control group (enamel) etched for 30-sec, washed for 15-sec and air dried to a frosty white. The tough brackets will be attached, with a baseline underneath, with a thin layer of composite resin pressed down on optimum. Light cured for 10 seconds on mesial and distal surfaces to remove excess adhesive (STEP 7).
Group II (V-Prep): Enamel surface was were in contact with 0%-1.5% diluted Sodium Hypochlorite during 60 seconds, rinsed and thoroughly dried; then the V-Prep was applied. 37% phosphoric acid gel for 30 Sec, rinsed for 15 Sec and dried until a frost white appearance on the etched enamel area. The first is called Primer and will be light cured for 10 seconds. A template will then be provisionally fixed to secure the bottom of the bracket in place with Resin-Modified Glass Ionomer Cement. Clean of excess adhesive, and cure for 10 seconds mesial and distal.
Then instead of going to bonding, this will be taken out and ligated to a 0.012-in Ni-Ti archwire. Will follow a 30 days interval series of 6 follow-up visits, monthly visits throughout 6 months
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Ethical approval will be obtained by the FUSH and informed consent will be obtained from individual patients/guardians in writing. Inclusion and exclusion criteria will be used to obtain random patient samples within the Orthodontic Department of FUCD&H and Baseline parameters like age, gender, O'Leary Plaque Score, malocclusion classification type and degree of overbite will be recorded. Patients will be screened one at a time if they are eligible. For this purpose, sequentially numbered, opaque sealed envelopes will be opened just before the bonding assignment for allocation concealment. Both orally and in writing to all patients. Tooth surfaces will be pumiced and standardized. To minimize inter-operator variability for any of the procedures listed above, all bonding will be completed by a single operator (principal investigator) that has been trained on the trial.
While, the Primer light-cured for 10-sec each item, the Control group (enamel) etched for 30-sec, washed for 15-sec and air dried to a frosty white. The tough brackets will be attached, with a baseline underneath, with a thin layer of composite resin pressed down on optimum. Light cured for 10 seconds on mesial and distal surfaces to remove excess adhesive (STEP 7).
Group II (V-Prep): Enamel surface was were in contact with 0%-1.5% diluted Sodium Hypochlorite during 60 seconds, rinsed and thoroughly dried; then the V-Prep was applied. 37% phosphoric acid gel for 30 Sec, rinsed for 15 Sec and dried until a frost white appearance on the etched enamel area. The first is called Primer and will be light cured for 10 seconds. A template will then be provisionally fixed to secure the bottom of the bracket in place with Resin-Modified Glass Ionomer Cement. Clean of excess adhesive, and cure for 10 seconds mesial and distal Then instead of going to bonding, this will be taken out and ligated to a 0.012-in Ni-Ti archwire. Will follow a 30 days interval series of 6 follow-up visits, monthly visits throughout 6 months
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Punjab Province
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Rawalpindi, Punjab Province, Pakistan, 44000
- Foundation University College of Dentistry and Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Patients aged 12-18 years
- The extraction was limited to Two arches.
- Functional Overbite/Underbite ( < 50% or 1, 2-3 mm?)
- Malocclusions Class I or II
Exclusion Criteria:
- Class III malocclusion
- Type 2: Facial Osteopathy (Cleft lip or palate)
- The history of allergic reactions to dental materials goes back to 1903.Allergic reactions to dental materials date back to 1903.
- Developmental enamel defects (fluorosis, hypoplasia)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: V-Prep and Resin-Modified Glass Ionomer Cement
V prep with sodium hypochlorite and bonding with RMGIC
|
V-Prep with sodium hypochlorite and bonding with Resin-Modified Glass Ionomer Cement
|
|
Comparatore attivo: Conventional Acid-Etch Composite Resin
Conventional Composite Resin Bonding
|
Conventional Composite Resin bonding
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Bond Failure Rate of Orthodontic Brackets
Lasso di tempo: 6 months
|
Time-to-failure of orthodontic brackets between the V-Prep and Resin-Modified Glass Ionomer Cement [RMGIC] and conventional 37% phosphoric acid-etch composite resin technique.
|
6 months
|
Collaboratori e investigatori
Sponsor
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
Altri numeri di identificazione dello studio
- FUCD-Ortho- 26
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
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Studia un dispositivo regolamentato dalla FDA degli 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 .