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Register:	ClinicalTrials.gov
Last refreshed on:	12 October 2015
Main ID:	NCT02185573
Date of registration:	04/07/2014
Prospective Registration:	No
Primary sponsor:	Damascus University
Public title:	Evaluation of Two Different Methods of Resin Composite Application In Class II Restorations
Scientific title:	Evaluation of Two Different Methods of Resin Composite Application Using Bulk-fill Technique In Class II Restorations
Date of first enrolment:	July 2014
Target sample size:	60
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02185573
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase:	N/A

Countries of recruitment
Syrian Arab Republic

Contacts

Name:	Rahaf Alkurdi, DDS MSc
Address:
Telephone:
Email:
Affiliation:	PhD student, Department of Operative Dentistry, University of Damascus Dental School, Damascus

Name:	Souad Abboud, DDS MSc PhD
Address:
Telephone:
Email:
Affiliation:	Associate Professor, Operative Dentistry Department, University of Damascus Dental School, Damascus

Key inclusion & exclusion criteria

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.

Age minimum: 15 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Class II Dental Restorations

Intervention(s)

Procedure: Bulk fill

Procedure: SonicFill

Primary Outcome(s)

Change in Surface Texture [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 Color Match [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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.]

Secondary Outcome(s)

Secondary ID(s)

UDDS-OperDent-01-2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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