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5 year clinical evaluation of indirect full ceramic restorations(CEREC)

Protocol summary

Summary
Purpose: To evaluate the 5 year clinical performance of CEREC All ceramic indirect restorations, placed on tooth and implant abutments. Inclusion criteria: consisted of having received an indirect CAD/CAM all- ceramic restoration from the same private practice during the aforementioned time span Population and Sample size: 230 patients who had received CAD-CAM ceramic restorations (Cerec) between March 2009 to March 2010. Restorations consisted of veneers, inlay , onlay and crowns on natural tooth and implant abutments. Treatment was performed by one prosthodontist in a private clinic. Intervention and Time: The patients were recalled to be examined after 6 and 1224, 36, 48 and 60 months intervals. The follow-up examinations were performed by 2 prosthodontists other than the clinician who had placed restorations. For each patient, These data were collected: sex, age at crown delivery, tooth or implant position, luting agent, occluding teeth, endodontic treatment before delivery, post and core material, occlusal contacts, and periodontal parameters. CDA guidelines were used to evaluate the quality of restorations. Variables Alpha and Bravo (excellent and acceptable) were defined as successes, whereas variables Charlie and Delta (not acceptable) were defined as failures and remake of crown was necessary. The treatment was also considered a failure when the abutment tooth was extracted or implant failed following biologic complication. The patients were interviewed regarding their satisfaction using a visual analogue scale (VAS).

General information

Acronym
CAD/CAM
IRCT registration information
IRCT registration number: IRCT2014083118981N1
Registration date: 2014-10-24, 1393/08/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-10-24, 1393/08/02
Registrant information
Name
Omid Savabi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2812
Email address
savabi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan university of medical science
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
5 year clinical evaluation of indirect full ceramic restorations(CEREC)
Public title
Survival and success rate of CAD/CAM All-ceramic crowns.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria Patients who referred to the clinic.;Patients which indirect CAD/CAM all- ceramic restoration has indication for their treatment.;Patients who needed single implant treatment. Exclusion criteria Patients who don't accept to enter the study.; Indirect all-ceramic restorations was contraindicated as a treatment option.
Age
From 18 years old to 78 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 230
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan Regional Bioethics Committee
Street address
University of Medical Sciences
City
Isafahn
Postal code
8174673461
Approval date
2014-07-23, 1393/05/01
Ethics committee reference number
393400

Health conditions studied

1

Description of health condition studied
Other special examinations and investigations of persons without complaint or reported diagnosis
ICD-10 code
Z01.2
ICD-10 code description
Dental examination

Primary outcomes

1

Description
Survive or failure of treatment
Timepoint
6 ,12,24,36,48 and 60 months with calculation from the date of the insertion
Method of measurement
Clinical examination

Secondary outcomes

1

Description
Evaluation of technical and biological complications
Timepoint
6 ,12,24,36,48 and 60 months with calculation from the date of the insertion
Method of measurement
CDA guidelines for indirect restorations and periodontal parameters(Gingival Index, Plaque Index ,Probing pocket depth ,Bleeding on probing ) for periodontal evaluations.

Intervention groups

1

Description
Intervention group 1: For tooth- supported crowns the abutment teeth were prepared with a circumstantially rounded shoulder (1.0 mm in width), an axial reduction of 1.5 mm, and an occlusal reduction of 1.5 to 2.0 mm with 6 to 7° taper. The preparation margins were located at the gingival level or not more than 1 mm subgingivally. Preparation protocol for inlays and onlays was as follows: 1.5-2.0 mm pulpal floor depth, 1.0-1.5 mm axial reduction, 2.0 mm isthmus width, 1.5-2.0 mm occlusal reduction with Rounded internal line angles. For veneers average labial reduction was 0.5 mm with a long chamfer margin. After preparation, the teeth were isolated by cotton roll and saliva ejector and were scanned with CEREC BlueCam (CEREC AC) from occlusal and buccul view and in occlusion. Restorations were designed with digital design software (CEREC 3D 3.85) and milled from ُSirona glass ceramic blocks, Empress CAD, or emax CAD in a standard speed. After milling proximal contacts and static and dynamic occlusal contacts were checked and corrected with fine diamond burs and water cooling. Silicon disclosing medium (Fit Checker, GC Co) was used to check the fit of restorations. Resin cements were used for luting of the tooth-supported restorations. The patients were recalled to be examined after 6 and 12, 24, 36, 48 and 60 months intervals. The follow-up examinations were performed by 2 prosthodontists other than the clinician who had placed restorations. For each patient, These data were collected: sex, age at crown delivery, tooth or implant position, luting agent, occluding teeth, endodontic treatment before delivery, post and core material, occlusal contacts, and periodontal parameters. CDA guidelines were used to evaluate the quality of restorations. Variables Alpha and Bravo (excellent and acceptable) were defined as successes, whereas variables Charlie and Delta (not acceptable) were defined as failures. The tooth extraction or loss of vitality or any condition result in remake of restoration were also consider as failure.
Category
Treatment - Other

2

Description
Intervention group 2; intervention1: For Implant-supported restorations, the implants were non-submerged (Soft tissue level, ITI Dental Implant System, Straumann AG, Basel, Switzerland). Conventional delayed loading protocol was followed after implant placement. All of the abutments were solid abutments. Abutments were scanned intraoraly with CEREC BlueCam (CEREC AC) from occlusal and buccul view and in occlusion. Restorations were designed with digital design software (CEREC 3D 3.85) and milled from emax CAD in a standard speed. Silicon disclosing medium (Fit Checker, GC Co) was used to check the fit of restorations. Resin cements were used for cementation of the Implant-supported restorations. The patients were recalled to be examined after 6 and 12, 24, 36, 48 and 60 months intervals. The follow-up examinations were performed by 2 prosthodontists other than the clinician who had placed restorations. For each patient, these data were collected: sex, age at crown delivery, implant position, luting agent, occluding teeth, occlusal contacts, and periodontal parameters. CDA guidelines were used to evaluate the quality of restorations. Variables Alpha and Bravo (excellent and acceptable) were defined as successes, whereas variables Charlie and Delta (not acceptable) were defined as failures and remake of crown was necessary. The treatment was also considered as a failure when implant failed following biologic complication. The patients were interviewed regarding their satisfaction using a visual analogue scale (VAS).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Universuty of Medical Sciences
Full name of responsible person
Dr. Omid Savabi
Street address
#400و Sheikhsaddogh St
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
ِResearch Deputy of Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman Adibi
Street address
Hezar jarib St, Isfahan University of Medical Sciences, School of Dentistry
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ِResearch Deputy of Research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Dr Omid Savabi
Position
Director of Research Program of School of Dentistry
Other areas of specialty/work
Street address
School of dentistry, Isfahan University of Medical Sciences,Hezar Jerib St.
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2812
Fax
+98 31116692585
Email
savabi@dnt.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Omid Savabi
Position
Prosthodontist/ Professor
Other areas of specialty/work
Street address
School Of Dentistry, Isfahan university of Medical Sciences
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2812
Fax
+98 31136692585
Email
savabi@dnt.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
isfahan university of medical science
Full name of responsible person
dr omid savabi
Position
Professor of Prosthodontist
Other areas of specialty/work
Street address
faculty of Dentistry ,Isfahan university of Medical Sciences,st hezarjarib,isfahan
City
isfahan
Postal code
8174673461
Phone
+98 31 3792 2812
Fax
+98 31 1669 2585
Email
savabi@dnt.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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