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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609914528644 Date of Registration: 04/09/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Accuracy of different maxillary custom record tray
Official scientific title Trueness of final impression using different custom-made trays for the edentulous maxilla using three -dimensional analysis (non-randomized cross over study).
Brief summary describing the background and objectives of the trial Background: The single-step closed-mouth impression technique for completely edentulous patients would reduce the number of visits required for complete denture fabrication. The step of final impression using customized trays is one of the important steps in complete denture fabrication that requires great accuracy, as it would affect retention, stability, and support of the final complete denture. So, the question now arises: will the use of two different types of customized trays- conventional and printed stackable CAD/CAM trays result in the same accuracy for the single closed-mouth impression technique? Objectives: Compare the trueness of the single-step impression technique of the conventional and the novel stackable CAD/CAM customized impression tray for the edentulous maxilla using three-dimensional analysis. Will CAD/ACM customized trays provide better trueness than conventional custom trays for the edentulous maxilla using the single-step closed-mouth technique?
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Final impression technique for the edentulous maxilla
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Determine the truness and accuarcy of different custom made trays for edentulous patients
Anticipated trial start date 07/06/2026
Actual trial start date 07/06/2025
Anticipated date of last follow up 01/07/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 3
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Allocation Sequence/Code was not concealed Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Stackable PRINTED Custom trays immediate after impression taking A stackable occlusion rim was designed on top of the custom tray to follow the ridge shape. The maxillary and mandibular stackable trays were then printed using 3D printer. This novel CAD/CAM custom tray would combine the custom impression tray and denture base for recording a jaw relation record in a single customized tray. 3
Control Group Conventional custom tray Immediate after impression taking While the maxillary stone model of each patient was used to fabricate a conventional custom record tray with occlusion rims made of wax, this was the Conventional group (CO) The maxillary and mandibular cutsom trays of the CO and the I group, were checked for proper seating, with no signs of rocking and it was checked to be 2mm shorter than the vestibule to allow for proper border molding. For each patient two maxillary and mandibular impressions and a jaw relation was recorded at the same visit using the conventional (CO) and intervention (I) custom trays. For both trays the occlusion rims were checked; the maxillary occlusal plane was adjusted to be parallel to the inter-pupillary lines anteriorly and alaa-tragus line posteriorly.The occlusion rim of the CO and I custom tray was modified to be of proper vertical dimension, and of even contact during biting. At the proper vertical dimension the patient was guided to close in centric relation, which was recorded using soft was (wax wafer method). For the I group, the printed occlusion rims had v shaped notches on the occlusal surface inorder to allow for jaw relation recording recording Border molding of the maxillary and mandibular arches was then carried out while the patient was biting at the proper vertical diemnsion and centric relation for both trays.The secondary impression using ZNO and eugenol (Cavex, Netherlands) was used to record the maxillary and mandiular arches during biting ( closed mouth impression technique). While the maxillary stone model of each patient was used to fabricate a conventional custom record tray with occlusion rims made of wax, this was the Conventional group (CO) 3 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 60-75 years, Cooperative patients who are willing to have a complete denture, Patients who are not medically compromised, Patients classified as class I and II according to McGarry 1990. Patients with; -Flabby tissue, -Severe hyperplasia, Patients class IV according to Mc Garry 1990. Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 60 Year(s) 75 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 26/01/2026 Scientific Research Ethics Committee of Kafrelsheikh University
Ethics Committee Address
Street address City Postal code Country
Kafrelsheikh University Kafrelsheikh 19984 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Using the Geomagic X software (Geomagic Control X; 3D Systems), the STL scan files of the conventional (CO) and Intervention (I) group were compared and superimposed on the Refrence Scan (RS) to assess the truness of the CO conventional group and Intervention group I and several landmarks were used to evaluate the accuracy of impression for both groups CO and I; palatal area, posterior palaltal seal, anterior border seal, maxillary tuberosity, crest of the ridge. The CO and I were superimposed onto the reference scan using the best-fit algorithm in Geomagic Control X software (Geomagic Control X; 3D Systems) using identified reference points; incisive papilla rugae areas. Initially, the scans were aligned using the software’s pre-alignment feature, followed by precise alignment using the “Local Best-Fit” function based on predetermined virtual landmarks to minimize errors. The software automatically identified and matched corresponding points to complete the superimposition process. Three-dimensional (3D) linear deviations were then calculated using the Geomagic Control X software (Geomagic Control X; 3D Systems, Canada). The software computed both the Mean deviation and the Root Mean Square (RMS) values using built-in algorithms. Concerning the Mean values, a positive deviation value indicates an outward direction from the reference model, while a negative value indicates an inward direction, representing the spatial difference between the scan and the reference. On the other hand the RMS value reflects the degree to which the deviation between the datasets differs from zero, with lower RMS values indicating higher three-dimensional accuracy Immediate after impression taking
Secondary Outcome Precision between the different impressions for both customized trays immediate after impression taking
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Dentistry Kaser El EINY STREET Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nouran Abdel Nabi Kaser El einy street Cairo Egypt
Nourhan Ragheb Kafer el sheikh university Kafer el sheikh Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nouran Abdel nabi 24 STREET 263 Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nouran Abdel Nabi Nouranabdelnabi@dentistry.cu.ed.eg 00201001539310 24 street 263 new maadi
City Postal code Country Position/Affiliation
cairo Egypt Professor Department of Prosthodontics Cairo University
Role Name Email Phone Street address
Public Enquiries Nourhan Ragheb norhan_ragheb@den.kfs.edu.eg 00201005442919 FACULTY OF DENTISTRY-Kafr el sheikh university
City Postal code Country Position/Affiliation
kafr el sheikh Egypt Associate professor Department of prosthodontics kaferelsheihk university
Role Name Email Phone Street address
Scientific Enquiries Marco Foad drmarcofouad073@gmail.com 00201224351829 Egyptian russian univeristy -Cairo Egypt
City Postal code Country Position/Affiliation
Egypt Egypt Lecturer department of prosthodontics Russian University Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data that underlie the results reported in this article will be shared with researchers who provide a methodologically sound proposal. The data will be available immediately ( as there is no follow-up in this study) after article publication via email to the corresponding author. The study protocol and the informed consent will accompany the data when required through the corresponding author . The data will be available staright after publication. Informed Consent Form,Study Protocol immediate outcome -there is actually no follow up Impression obtained using both trays will be evaluated; - No tearing of impression -Homogenous mix of impression material -proper border molding
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 18/08/2026 The reviewer's comments was to include the background, and objectives of teh study Compare the trueness of the single-step impression technique of the conventional and the novel stackable CAD/CAM customized impression tray for the edentulous maxilla using three-dimensional analysis. Will CAD/ACM customized trays provide better trueness than conventional custom trays for the edentulous maxilla using the single step closed mouth techniques? Background: The single-step closed-mouth impression technique for completely edentulous patients would reduce the number of visits required for complete denture fabrication. The step of final impression using customized trays is one of the important steps in complete denture fabrication that requires great accuracy, as it would affect retention, stability, and support of the final complete denture. So, the question now arises: will the use of two different types of customized trays- conventional and printed stackable CAD/CAM trays result in the same accuracy for the single closed-mouth impression technique? Objectives: Compare the trueness of the single-step impression technique of the conventional and the novel stackable CAD/CAM customized impression tray for the edentulous maxilla using three-dimensional analysis. Will CAD/ACM customized trays provide better trueness than conventional custom trays for the edentulous maxilla using the single step closed mouth techniques?
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 27/08/2026 background added Background: The single-step closed-mouth impression technique for completely edentulous patients would reduce the number of visits required for complete denture fabrication. The step of final impression using customized trays is one of the important steps in complete denture fabrication that requires great accuracy, as it would affect retention, stability, and support of the final complete denture. So, the question now arises: will the use of two different types of customized trays- conventional and printed stackable CAD/CAM trays result in the same accuracy for the single closed-mouth impression technique? Objectives: Compare the trueness of the single-step impression technique of the conventional and the novel stackable CAD/CAM customized impression tray for the edentulous maxilla using three-dimensional analysis. Will CAD/ACM customized trays provide better trueness than conventional custom trays for the edentulous maxilla using the single step closed mouth techniques? Background: The single-step closed-mouth impression technique for completely edentulous patients would reduce the number of visits required for complete denture fabrication. The step of final impression using customized trays is one of the important steps in complete denture fabrication that requires great accuracy, as it would affect retention, stability, and support of the final complete denture. So, the question now arises: will the use of two different types of customized trays- conventional and printed stackable CAD/CAM trays result in the same accuracy for the single closed-mouth impression technique? Objectives: Compare the trueness of the single-step impression technique of the conventional and the novel stackable CAD/CAM customized impression tray for the edentulous maxilla using three-dimensional analysis. Will CAD/ACM customized trays provide better trueness than conventional custom trays for the edentulous maxilla using the single-step closed-mouth technique?
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 04/09/2026 PACTR Admin 07 Jun 2025
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 18/08/2026 Each criteria in a seperate line Patients aged 60-75 years, Co-operative patients who are willing to have a complete denture, Patients that are not medically compromised, Patients classified as class I and II according to McGarry 1990. Patients aged 60-75 years, Cooperative patients who are willing to have a complete denture, Patients who are not medically compromised, Patients classified as class I and II according to McGarry 1990.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 18/08/2026 Each criteria in a seperate line Patients with flabby tissue, and severe hyperplasia, Patients class IV according to Mc Garry 1990. Patients with; -Flabby tissue, -Severe hyperplasia, Patients class IV according to Mc Garry 1990.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 18/08/2026 All age groups ticked Aged: 65 Year(s)-79 Year(s) Middle Aged: 45 Year(s)-64 Year(s), Aged: 65 Year(s)-79 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 18/08/2026 no change Other
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Other disease 18/08/2026 The reviewer comment required stating the disease condition Final impression technique for the edentulous maxilla
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 18/08/2026 reviwer comment required all funding sources by name Self funded, Kaser El einy street, Cairo, , Egypt, Self Funded, Nouran Abdel Nabi , Kaser El einy street, Cairo, , Egypt, Other, the principle invesyigator
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 18/08/2026 reviwer comment required all funding sources by name Nourhan Ragheb, Kafer el sheikh university , Kafer el sheikh, , Egypt, Other, public inquiry
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 18/08/2026 The reviewer comment required the change No statistically significant difference in trueness between the CO and I group. The posterior palatal seal area and maxillary tuberosity showed greatest non-significant deviation. De-identified individual participant data that underlie the results reported in this article will be shared with researchers who provide a methodologically sound proposal. The data will be available immediately ( as there is no follow-up in this study) after article publication via email to the corresponding author. The study protocol and the informed consent will accompany the data when required through the corresponding author . The data will be available staright after publication.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 18/08/2026 The reviewer comment required the change Informed Consent Form Study Protocol, Informed Consent Form