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.: PACTR202207905981251 Date of Approval: 06/07/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical accuracy of dynamic virtual interocclusal registration with intraoral scanner
Official scientific title Clinical accuracy of dynamic virtual interocclusal registration with intraoral scanner
Brief summary describing the background and objectives of the trial Background: Available intraoral scanners software has integrated the option of registering eccentric interocclusal records from the patient mouth, these records can eliminate the need for the conventional eccentric records needed for programming virtual articulators if the virtual dynamic records introduced to the CAD software used for restoration designing. In addition, the virtual dynamic records can be utilized for occlusal analysis for the patients in more fast and comfortable way. Aim of the study: this study aimed to evaluate the accuracy of dynamic virtual interocclusal records obtained with intraoral scanner. Methods: ten participants will be recruited and participate in both study group. Full arch scans and dynamic virtual occlusal records will be obtained from the participants in protrusive and lateral dynamic occlusion. The virtually detected occlusal contacts will be identified using the intraoral scanner software. The virtual contacts will be saved by screenshots. The analogue dynamic occlusal contacts will be marked with an articulating paper and photographs will be taken. The percentage of true virtual occlusal contacts identified with the scanner software compared to analogue contacts will be calculated. Results: Measurements will be collected and statistically analyzed
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied dental occlusion analysis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/07/2022
Actual trial start date 01/07/2022
Anticipated date of last follow up 01/08/2022
Actual Last follow-up date 01/08/2022
Anticipated target sample size (number of participants) 9
Actual target sample size (number of participants) 9
Recruitment status Active, not recruiting
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 Non-randomised Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Articulating paper once per participant once detecting dynamic occlusal contacts with articulating paper 9 Dose Comparison
Experimental Group virtual detection of occlusal contacts once per patient once virtual detection of occlusal contacts with intraoral scanner 9
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients aged between 19 and 44 years full dentate healthy dentition edentulous cases TMJ disorders 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 19/06/2022 research ethics committee at faculty of dentistry Alexandria University
Ethics Committee Address
Street address City Postal code Country
Champlion st, Azarita Alexandria 003 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome accuracy of dynamic virtual bite registration endpoint
Primary Outcome virtual detection of dynamic occlusal contacts endpoint
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
private clinic Camb de cezar st Alexandria 003 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Noha Morsy Camb De cezar St Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Ahmed Menecy Camb De Cezar St Alexandria Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Noha Morsy nohamorsy.nm88@yahoo.com 00201062744333 Camb De Cezar
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer at faculty of dentistry alexandria university
Role Name Email Phone Street address
Public Enquiries Ahmed Menecy ahmedmenecy@gmail.com 00201006367797 Camb De cezar st
City Postal code Country Position/Affiliation
Alexandria Egypt Faculty of dentistry Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Mohammed El kateb prof_elkateb@yahoo.com 00201122644189 Azarita
City Postal code Country Position/Affiliation
Alexandria Egypt Professor at faculty of dentistry Alexandria university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the individual participant data will be available for all included participants after deidentification Study Protocol 9 months the data will be available through e-mail of the corresponding author and via publication according to the policy stated by the journal and publisher
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information