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

2 oktober 2015 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Syrien Arabrepubliken
      • Damascus, Syrien Arabrepubliken, DM20AM18
        • Department of Operative Dentistry, University of Damascus Dental School

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

15 år till 60 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Conventional Technique
Multi-layer filling technique
Aktiv komparator: Bulk fill technique
Procedur: Bulk fill
This is one of the composite restoration application techniques
Experimentell: SonicFill technique
Procedur: SonicFill
This is the recent intervention under evaluation

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Color Match
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Damascus University

Utredare

  • Huvudutredare: Rahaf Alkurdi, DDS MSc, PhD student, Department of Operative Dentistry, University of Damascus Dental School, Damascus
  • Studierektor: Souad Abboud, DDS MSc PhD, Associate Professor, Operative Dentistry Department, University of Damascus Dental School, Damascus

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2014

Primärt slutförande (Faktisk)

1 juli 2015

Avslutad studie (Faktisk)

1 oktober 2015

Studieregistreringsdatum

Först inskickad

4 juli 2014

Först inskickad som uppfyllde QC-kriterierna

4 juli 2014

Första postat (Uppskatta)

9 juli 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

5 oktober 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 oktober 2015

Senast verifierad

1 oktober 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • UDDS-OperDent-01-2014

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