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IRCT20160213026538N5 IRCT 2020-05-17 Kermanshah University of Medical Sciences Comprative study the clinical outcomes of the Endocrowns and Conventional crowns Comprative study the clinical outcomes of the Endocrowns and Conventional crowns fabricated by Computer Aided Design/Computer Aided Manufacturing (CAD/CAM): A Randomized clinical trial 2020-05-21 anticipated 44 Complete https://irct.ir/trial/48060 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the random allocation law, after determining 44 maxillary and mandibular molars based on statistical calculations, 22 cards for the Endocrown group and 22 cards for the Conventional crown group will be placed in a draw glass, then the cards will be dropped out randomly and without replacement and the resulting sequence will be recorded.Then,44 envelopes are prepared and each random sequence created is recorded on a card and the cards are inserted into the envelope respectively. In order to maintain a random sequence, the envelopes are numbered to the same. In the end, the door covers are enclosed in boxes and placed in a box respectively. At the time of the start of the registration of the participants, according to the order of entry of qualified participants to study, one of the envelopes are opened in sequence and the participant's assigned group is revealed, Blinding description: in this clinical trial study, only the prosthodontist who insert the crowns and endocrowns knows about the groups and the outcome evaluators(other prosthodontist and the calibrated examiner) are blind to the assignment of each participant in each of the study groups. Participants in the study are blind toward their own group when they are aware of the similar costs and benefits of clinical treatments based on studies. Also the result analyst, have no information about the data of each group.It should be mentioned as the restorations have no differences in appearance after insertion,triple blinding is available. N/A Condition 1: Shade match of Endocrown Compared to Conventional Crown. Condition 2: Fracture of Endocrown Compared to Conventional Crown. Condition 3: Surface texture of Endocrown Compared to Conventional Crown. Condition 4: Marginal integrity of Endocrown Compared to Conventional Crown. Condition 5: Retention of Endocrown Compared to Conventional Crown. Condition 6: Recurrent caries in Endocrown Compared to Conventional Crown. Condition 7: Wear of Endocrown Compared to Conventional Crown. Condition 8: Antagonist Wear in Endocrown Compared to Conventional Crown. Condition 9: Periodontal health in Endocrown Compared to Conventional Crown. Intervention 1: Control group: Conventional crowns made from Litium disilicate glass-ceramics and fabricated by CAD/CAM. Intervention 2: Intervention group: Endocrowns made from Litium disilicate glass-ceramics and fabricated by CAD/CAM. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mohadese faize rahnemoon
The school of Dentistry, shariati St.
Kermanshah Iran (Islamic Republic of) 67139546581 +98 83 3727 7030 Mf73faize@gmail.com Kermanshah University of Medical Sciences scientific Hedaiat Moradpoor
Department of Prosthodontics, The School of Dentistry, Kermanshah University of Medical Siences, Shariati St.
Kermanshah Iran (Islamic Republic of) 67139546581 +98 83 3729 6910 h.moradpour@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Patients who need their maxillary or mandibular teeth to be restored and have the opposite teeth in functional occlusion and at least one proximal contact with the adjacent teeth Acceptable oral hygiene and periodontally healthy(plaque index and bleeding on probing had to be below 20% previously to the prosthodontic treatment) Good general health(no systemic disease that should negatively influence the clinical outcome) No obvious signs or symptoms of bruxing and/or clenching (bruxism such as attritions and existing fractures on the patients natural teeth or reconstructions, no pain on muscular palpation or tendomyopathies, No pain causing joint sound, no selfreported bruxing or clenching) The patient is ready to take part in the study and sign the testimonial 18 years no limit Both Presence of para-functional habits including clenching,bruxism or grinding Presence of periodontal problems and dental or medical history that can complicate the preparation of the restoration The lack of cooperation of the patients to observe oral hygiene( Plaque index and BOP should be below 20%) Treatment - Other Treatment - Other Control group: Conventional crowns made from Litium disilicate glass-ceramics and fabricated by CAD/CAM Intervention group: Endocrowns made from Litium disilicate glass-ceramics and fabricated by CAD/CAM Shade match of Endocrown and Conventional Crown. Timepoint: At the time of the restoration insertion,1 week later,3 and 6 months later. Method of measurement: California Dental Association(CDA) Follow up evaluation criteria. Surface texture of Endocrown and Conventional Crown. Timepoint: At the time of the restoration insertion,1 week later,3 and 6 months later. Method of measurement: California Dental Association(CDA) Follow up evaluation criteria. Marginal integrity of Endocrown and Conventional Crown. Timepoint: At the time of the restoration insertion,1 week later,3 and 6 months later. Method of measurement: California Dental Association(CDA) Follow up evaluation criteria. Fracture of Endocrown and Conventional Crown. Timepoint: At the time of the restoration insertion,1 week later,3 and 6 months later. Method of measurement: California Dental Association(CDA) Follow up evaluation criteria. Recurrent Caries in Endocrown and Conventional Crown. Timepoint: At the time of the restoration insertion,1 week later,3 and 6 months later. Method of measurement: California Dental Association(CDA) Follow up evaluation criteria. Retention in Endocrown and Conventional Crown. Timepoint: At the time of the restoration insertion,1 week later,3 and 6 months later. Method of measurement: California Dental Association(CDA) Follow up evaluation criteria. Mobility of the tooth in Endocrown and Conventional Crown. Timepoint: At the time of the restoration insertion,1 week later,3 and 6 months later. Method of measurement: By a dental mirror. Wear of Endocrown and Conventional Crown. Timepoint: At the time of the restoration insertion,1 week later,3 and 6 months later. Method of measurement: California Dental Association(CDA) Follow up evaluation criteria. Antagonist Wear in Endocrown and Conventional Crown. Timepoint: At the time of the restoration insertion,1 week later,3 and 6 months later. Method of measurement: California Dental Association(CDA) Follow up evaluation criteria. Pocket depth in Endocrown and Conventional Crown. Timepoint: At the time of the restoration insertion,1 week later,3 and 6 months later. Method of measurement: Dental probe. Bleeding on probing in Endocrown and Conventional Crown. Timepoint: At the time of the restoration insertion,1 week later,3 and 6 months later. Method of measurement: Dental probe. Gingival index in Endocrown and Conventional Crown. Timepoint: At the time of the restoration insertion,1 week later,3 and 6 months later. Method of measurement: Gingival index. Plaque index in Endocrown and Conventional Crown. Timepoint: At the time of the restoration insertion,1 week later,3 and 6 months later. Method of measurement: Plaque index. Kermanshah University of Medical Sciences Approved 2020-01-14 Ethics Committee of Kermanshah University of Medical Sciences Ethics Committee, Department of Research and Technology, Central Building, Shahid Beheshti Boulevard, Kermanshah kermanshah Kermanshah Iran (Islamic Republic of)