Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202008685699453 Date of Approval: 11/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Fit of monolithic multilayer zirconia fixed partial dentures fabricated by conventional versus digital impression: a clinical and laboratory investigations.
Official scientific title EVALUATION OF CONVENTIONAL AND DIGITAL IMPRESSIONS ACCURACY: A CLINICAL AND COMPUTER-AIDED THREE-DIMENSIONAL ANALYSIS (IN-VITRO STUDY AND CLINICAL TRIAL)
Brief summary describing the background and objectives of the trial Conventional impression is the gold standard in fixed prosthesis due to its availability and reasonable cost, in addition to recent advances in material technology. On the other hand, factors such as impression technique, expansion of gypsum casts, and inability to correct imprecision during impression taking influence the clinical fit of the restorations. New systems for direct intraoral digitalization have been introduced to dentistry. Despite its relatively high cost, digital intraoral impression provides multiple advantages that may enhance the fit accuracy of the final restoration, including chair-side analysis of the preparation, selective scanning of particular areas, digital archiving and faster communication with the dental lab. CAD/CAM technology also allowed the fabrication of monolithic zirconia restorations which eliminate the risk of veneer chipping, simplifying the fabrication, and combining excellent aesthetics and biocompatibility with superior mechanical properties. Aim of the study: The aim of the study is to investigate the clinical fit of monolithic fixed partial dentures fabricated from novel translucent multilayer zirconia by conventional and digital impressions in-vivo, and to correlate the clinical results with trueness and precision values of the same intraoral scanner and conventional impression material measured using computer-aided 3D analysis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Dentistry, Fixed prosthodontics, fit accuracy of monolithic zirconia.
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/09/2019
Actual trial start date 01/10/2019
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date 31/01/2020
Anticipated target sample size (number of participants) 12
Actual target sample size (number of participants) 12
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group conventional dental impression once for each participant 5 minutes conventional single-step polyether impression 12 Active-Treatment of Control Group
Experimental Group digital impression once per each participant 10 minutes intraoral digital impression using CS 3500 intraoral scanner 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with a missing upper first premolar. Aged between 19 and 44 years. Good oral hygiene with compliance to perform strict oral hygiene measures (periodontal screening index 0-1). Well-aligned abutment teeth. Bad oral hygiene. Advanced periodontitis, gingivitis, or recession. Abutments with subgingival restorations or root caries. Parafunctional habits. Undergoing orthodontic treatment. Obvious dentition malalignment. Adult: 19 Year-44 Year 19 Year(s) 44 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/07/2019 The Research Ethics Committe at faculty of dentistry Alexandria University Egypt.
Ethics Committee Address
Street address City Postal code Country
Chmpollion St., Azarita, Alexandria, Egypt Alexandria 21500 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome internal and marginal fit accuracy of produced computer-aided designing/computer-aided milled fixed partial dentures Once, two weeks after the interventions
Secondary Outcome trueness and precision of both impression techniques Once, one week after the interventions
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University Faculty of dentistry Chmpollion st., Azarita Alexandria 21500 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
principal investigator Noha Morsy Metwaly Morsy 39 Abd el monaem sanad st, Alexandria , Egypt Alexandria 21500 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Noha Morsy Salem 39 Abd el monaem sanad st, Alexandria , Egypt Alexandria 21500 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Noha Morsy Salem 39 Abd el monaem sanad st, Alexandria , Egypt Alexandria 21500 Egypt
Mohammed Mahmoud El Kteb Chmpollion st., Azarita, Alexandria Alexandria 21500 Egypt
Amir Shoukry Azer Chmpollion St., Azarita, Alexandria Alexandria 21500 Egypt
Said Mohammed Fathallah Endenicher Alle, Bonn Bonn 53115 Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Noha Morsy nohamorsy.nm88@yahoo.com 20301062744333 39 Abd el monaem sanad st, Alexandria , Egypt
City Postal code Country Position/Affiliation
Alexandria 21500 Egypt Assistant lecturer of fixed prosthodontics faculty of dentistry Alexandria University Egypt
Role Name Email Phone Street address
Public Enquiries Mohammed El Kateb prof_elkateb@yahoo.com 20301062744333 Chmpollion st., Azarita
City Postal code Country Position/Affiliation
Alexandria 21500 Egypt professor of fixed prosthodontics at faculty of dentistry Alexandria university Egypt
Role Name Email Phone Street address
Public Enquiries Noha Morsy nohamorsy.nm88@yahoo.com 20301062744333 39 Abd el monaem sanad st, Alexandria , Egypt
City Postal code Country Position/Affiliation
Alexandria 21500 Egypt Assistant lecturer of fixed prosthodontics at faculty of dentistry Alexandria University Egypt
Role Name Email Phone Street address
Scientific Enquiries Amir Azer dr_amirazer@yahoo.com 20301062744333 Chmpollion st., Azarita
City Postal code Country Position/Affiliation
Alexandria 21500 Egypt lecturer of fixed prosthodontics at faculty of dentistry Alexandria university Egypt
Role Name Email Phone Street address
Scientific Enquiries Noha Morsy nohamorsy.nm88@yahoo.com 20301062744333 39 Abd el monaem sanad st, Alexandria , Egypt
City Postal code Country Position/Affiliation
Alexandria 21500 Egypt Assistant lecturer of fixed prosthodontics at faculty of dentistry Alexandria University Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underline results reported in the article(text, tables, figures, appendices) Study Protocol beginning 9 months and ending 5 years following article publication researches who provide a methodologically sound proposal or whose proposed use has been approved by an independent review committee can gain access to the data, for meta-analysis or to achieve the aim of the approved proposal, the data will be available on our university warehouse and further inquiries can be sent by the investigators to the principal researcher of this trial.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available Yes • the test group showed significantly better fit accuracy than the control with significantly less mean marginal gap value of 30.91µm compared to 40.02µm for group C (P=0.00126), and significantly lower internal gap mean value of 30.86 µm compared to 41.86µm for group C (P=0.00001). No significant difference was found between the test groups in trueness or precision (P=0.5). 01/12/2020 01/12/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://alexuuni-my.sharepoint.com/:b:/g/personal/noha_moursy_alexu_edu_eg/ERNeIPwVR31Gg-5y1mKn_EIBDhgOEbd6HSFdOYZWZT1b4A?e=ug47EM
Changes to trial information