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IRCT2014083118981N1 IRCT 2014-10-24 ِResearch Deputy of Research, Isfahan University of Medical Sciences Survival and success rate of CAD/CAM All-ceramic crowns. CAD/CAM 5 year clinical evaluation of indirect full ceramic restorations(CEREC) 2009-03-21 anticipated 230 Complete https://irct.ir/trial/17091 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Other special examinations and investigations of persons without complaint or reported diagnosis. Intervention 1: 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. Intervention 2: 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).
public Dr Omid Savabi
School of dentistry, Isfahan University of Medical Sciences,Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 2812 savabi@dnt.mui.ac.ir Isfahan University of Medical Science scientific Dr.Omid Savabi
School Of Dentistry, Isfahan university of Medical Sciences
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 2812 savabi@dnt.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 78 years Both Z01.2 Dental examination Treatment - Other Treatment - Other 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. 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). 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. 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. ِResearch Deputy of Research, Isfahan University of Medical Sciences Approved 2014-07-23 Isfahan Regional Bioethics Committee University of Medical Sciences Isafahn Iran (Islamic Republic of)