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Evaluation of Two Different Methods of Resin Composite Application In Class II Restorations

2 ottobre 2015 aggiornato da: Damascus University

Evaluation of Two Different Methods of Resin Composite Application Using Bulk-fill Technique In Class II Restorations

Three clinical groups will be evaluated. Each group of patients will undergo one method of Resin Composite application (multi-layer technique 'control group' - bulk-fill Technique - Sonicfill technique). The restored teeth will be followed-up till one year. A comparison is going to be made between the three groups in relation to the modified United Sates Public Health Service (USPHS) criteria of good restorations.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The modified USPHS criteria include the evaluation of seven characteristics of the restorations: color match, marginal integrity, surface texture, wear of both restoration and antagonist, recurrent dental caries, fracture or detachment, and gingivitis around the abutment.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Repubblica Araba Siriana
      • Damascus, Repubblica Araba Siriana, DM20AM18
        • Department of Operative Dentistry, University of Damascus Dental School

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 15 anni a 60 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Cooperated patients.
  2. Good general health.
  3. Good oral hygiene.
  4. Aged 15 to 60 years.
  5. Class II restoration (upper or lower)
  6. Full erupted teeth.
  7. Caries value D3 -D4 according to Daignodent.

Exclusion Criteria:

  1. If the caries value according to Daignodent is less than D3 -D4.
  2. If the tooth is partially erupted.
  3. Class II box-like cavity only without any extensions.
  4. Patient outside the required age range (15-60 years).
  5. Bad oral hygiene.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Conventional Technique
Multi-layer filling technique
Comparatore attivo: Bulk fill technique
Procedura: Bulk fill
This is one of the composite restoration application techniques
Sperimentale: SonicFill technique
Procedura: SonicFill
This is the recent intervention under evaluation

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Color Match
Lasso di tempo: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.

Color match

  1. The restoration appears to match the shade and translucency of adjacent tooth tissues.
  2. The restoration does not match the shade and translucency of adjacent tooth tissues, but the mismatch is within the range of tooth shade.
  3. The restoration does not match the shade and translucency of adjacent tooth tissues, and the mismatch is outside the normal range of tooth shade and translucency.
Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Change in Marginal Integrity
Lasso di tempo: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.

Marginal integrity

  1. The explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does catch, there is no visible crevice along the periphery of the restoration.
  2. The explorer catches and there is visible evidence of crevice, into which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure.
  3. the explorer penetrates a crevice defect.
Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Change in Surface Texture
Lasso di tempo: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.

Surface texture:

  1. Surface texture is similar to polished enamel as determined by means of a sharp explorer.
  2. Surface texture is gritty similar to a surface subject to a white stone or similar to a composite containing supramicron sizes particles.
  3. Surface pitting is sufficiently coarse to inhibit the continuous movement of an explorer across the surface.
Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Change in Restoration Wear
Lasso di tempo: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.

Wear

  1. The restoration is continuation of existing anatomic form or is slightly flattened.
  2. A surface concavity is evident.
  3. There is a loss of restorative substance such that a surface concavity is evident. Replacement or restorative treatment is required.
Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Recurrent dental caries
Lasso di tempo: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.

Recurrent dental caries:

  1. The restoration is a continuation of existing anatomic form adjacent to the restoration.
  2. There is visual evidence of dark deep discoloration adjacent to the restoration.
Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
The Fracture/detachment Status
Lasso di tempo: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.

Fracture/detachment:

  1. No bulk fracture/detachment is present.
  2. Bulk fracture/ detachment is evident.
Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Change in gingival status
Lasso di tempo: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.

Gingival status

  1. No clinical inflammation is present.
  2. Clinical inflammation is present.
Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Damascus University

Investigatori

  • Investigatore principale: Rahaf Alkurdi, DDS MSc, PhD student, Department of Operative Dentistry, University of Damascus Dental School, Damascus
  • Direttore dello studio: Souad Abboud, DDS MSc PhD, Associate Professor, Operative Dentistry Department, University of Damascus Dental School, Damascus

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2014

Completamento primario (Effettivo)

1 luglio 2015

Completamento dello studio (Effettivo)

1 ottobre 2015

Date di iscrizione allo studio

Primo inviato

4 luglio 2014

Primo inviato che soddisfa i criteri di controllo qualità

4 luglio 2014

Primo Inserito (Stima)

9 luglio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

5 ottobre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 ottobre 2015

Ultimo verificato

1 ottobre 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • UDDS-OperDent-01-2014

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 .

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