Ignite Creation Date:
2024-05-06 @ 6:08 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05551481
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2022-08-19
Brief Title:
Follow-up of Indirect Restorations Luted With Different Adhesive Resin Cement
Sponsor:
Istanbul Medipol University Hospital
Organization:
Istanbul Medipol University Hospital
Study Overview
Official Title:
2 Year Follow-up of Indirect Resin Composite Restorations Luted With Different Adhesive Resin Cement A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective To evaluate the clinical performance of indirect resin composite restorations which were luted with two different resin cement in posterior teeth for up to 2 years
Methods From February 2017 to May 2017 a total of 43 patients 21 men 22 women mean age received 48 onlay restorations made of laboratory-processed indirect composite Gradia GC Japan 27 onlay restorations Group A were luted using an etch and rinse resin cement Variolink II Ivoclar Vivadent and 22 onlay restorations Group B were luted using a self-adhesive resin cement Relyx U200 3M ESPE Patients were followed until May 2019 Two independent calibrated examiners evaluated the restorations at 3-time points 2 weeks after placement baseline 6 months and then annually using the modified USPHSFDI criteria
Methods From February 2017 to May 2017 a total of 43 patients 21 men 22 women mean age received 48 onlay restorations made of laboratory-processed indirect composite Gradia GC Japan 27 onlay restorations Group A were luted using an etch and rinse resin cement Variolink II Ivoclar Vivadent and 22 onlay restorations Group B were luted using a self-adhesive resin cement Relyx U200 3M ESPE Patients were followed until May 2019 Two independent calibrated examiners evaluated the restorations at 3-time points 2 weeks after placement baseline 6 months and then annually using the modified USPHSFDI criteria
Detailed Description:
Study design The ethical committee of Istanbul Medipol University approved this clinical study Patients were given written informed consent to participate before treatment and agreed to a recall program at baseline 2 weeks 6 months and thereafter annually All restorative procedures were carried out by one experienced dentist from the Department of Restorative Dentistry at Istanbul Medipol University
Inclusion and exclusion criteria
Patients in need of removal of old large amalgam restorations or having extensive caries lesions were recruited for the study Inclusion and exclusion criteria were as follows
Adults of at least 18 years of age with good oral hygiene having an antagonist tooth in occlusion being mentally in a good state to provide written consent to participate in the clinical study and willing to attend the scheduled follow-up appointments Exclusion criteria included the presence of teeth with severe periodontal problems high caries risk and bruxism
Cavities were prepared according to common principles which included an occlusal reduction of 15-2 mm with a wide isthmus and rounded occlusal-axial angles and an axial wall of 15 mm in thickness Where possible the gingival margins were prepared entirely in enamel at the cemento-enamel junction and cavities for overlays included both buccal and lingualpalatal cusps Both cavity types onlays and overlays were prepared with rounded internal angles with a divergence of 6-15 between the walls and margins with a 90 cave surface
Full-arch impressions were made with a single impressiondouble mixing technique using polyether material Impregum Penta H Duoso 3M ESPE Minn USA cavity preparations were provisionalized for 1 week with photo-polymerized provisional material Clip Voco Cuxhaven Germany All onlays were definitively inserted within 1 week after impression After the removal of provisional restorations the teeth were thoroughly cleaned with a prophylaxis brush and pumice
After adjustment when needed the restorations were luted adhesively under a rubber dam employing a total-etch system in group A The prepared teeth were initially cleaned with pumice slurry and etched with 35 phosphoric acid gel Ultra-etch Ultradent South Jordan UT USA The dentin adhesive system Syntac Classic Ivoclar Vivadent Liechtenstein was then applied uniform and gently air thinned The internal surface of the restorations was silanized Monobond S Ivoclar Vivadent waited for its reaction for 60 s and the solvent was evaporated with oil-free compressed air The onlays and overlays were luted adhesively with etch and rinse dual cure resin cement Variolink II Ivoclar Vivadent In Group B were luted using a self-adhesive resin cement Relyx U200 3M ESPE
Excess resin cement was removed in all cases with an explorer a brush and dental floss interproximally Each only surface was light-cured for 40 s with a polymerization light Elipar Highlight 3M Espe Seefeld Germany After placement and removal of the rubber dam static and dynamic occlusion was adjusted using fine grit diamond burs then inlays were finished with disks and strips Sof-Lex 3M Dental Products St Paul MN USA
Inclusion and exclusion criteria
Patients in need of removal of old large amalgam restorations or having extensive caries lesions were recruited for the study Inclusion and exclusion criteria were as follows
Adults of at least 18 years of age with good oral hygiene having an antagonist tooth in occlusion being mentally in a good state to provide written consent to participate in the clinical study and willing to attend the scheduled follow-up appointments Exclusion criteria included the presence of teeth with severe periodontal problems high caries risk and bruxism
Cavities were prepared according to common principles which included an occlusal reduction of 15-2 mm with a wide isthmus and rounded occlusal-axial angles and an axial wall of 15 mm in thickness Where possible the gingival margins were prepared entirely in enamel at the cemento-enamel junction and cavities for overlays included both buccal and lingualpalatal cusps Both cavity types onlays and overlays were prepared with rounded internal angles with a divergence of 6-15 between the walls and margins with a 90 cave surface
Full-arch impressions were made with a single impressiondouble mixing technique using polyether material Impregum Penta H Duoso 3M ESPE Minn USA cavity preparations were provisionalized for 1 week with photo-polymerized provisional material Clip Voco Cuxhaven Germany All onlays were definitively inserted within 1 week after impression After the removal of provisional restorations the teeth were thoroughly cleaned with a prophylaxis brush and pumice
After adjustment when needed the restorations were luted adhesively under a rubber dam employing a total-etch system in group A The prepared teeth were initially cleaned with pumice slurry and etched with 35 phosphoric acid gel Ultra-etch Ultradent South Jordan UT USA The dentin adhesive system Syntac Classic Ivoclar Vivadent Liechtenstein was then applied uniform and gently air thinned The internal surface of the restorations was silanized Monobond S Ivoclar Vivadent waited for its reaction for 60 s and the solvent was evaporated with oil-free compressed air The onlays and overlays were luted adhesively with etch and rinse dual cure resin cement Variolink II Ivoclar Vivadent In Group B were luted using a self-adhesive resin cement Relyx U200 3M ESPE
Excess resin cement was removed in all cases with an explorer a brush and dental floss interproximally Each only surface was light-cured for 40 s with a polymerization light Elipar Highlight 3M Espe Seefeld Germany After placement and removal of the rubber dam static and dynamic occlusion was adjusted using fine grit diamond burs then inlays were finished with disks and strips Sof-Lex 3M Dental Products St Paul MN USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None