Comparison of the Accuracy of Digital and Conventional Impression in Edentulous Arch
Phase: NA
Conditions: Edentulous Jaw
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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Shanghai Ninth Peoples Hospital affiliated to Shanghai 
Jiao Tong University School of Medicine 
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Shanghai Ninth Peoples Hospital affiliated to 
Shanghai Jiao Tong University School of 
Medicine 
Clinical research protocol 
 
 
 
p r o j e c t 
n a m e  ： 
Comparison of digital and traditional 
impressions in the absence of dental 
scanning 
 
v e r s i o n 
n u m b e r  ： 
1 .2 
Version date: 
14 September 2025            
p r o j e c t 
l e a d e r  ： 
Lai Hong-chang 
Date of plan start and end
  September 2025-December 202 
6         
 
 
 
 
 
 
 
 

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Jiao Tong University School of Medicine 
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Researcher statement and program signature page 
 
As the principal investigator of this research project, I will adhere to the 
Ethics Review Measures for Human Biomedical Research (Order No.11 [2016] 
of the National Health Commission), the Ethics Review Measures for Human 
Life Science and Medical Research (Guowei Jiaoke Fa [2023] No.4), and GCP 
ethical principles. The study will be conducted in accordance with the approved 
protocol by the ethics committee, ensuring scientific rigor while safeguarding 
participants health and rights. 
 
Name: Lai Hongchang 
________   
sign ones 
name ：  
Date: __ 20250 320_____  
 
 

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Test plan · Catalog 
I. PROGRAMME SUMMARY  ...................................................................................... 5 
II. RESEARCH BACKGROUND  .................................................................................. 6 
III. Objective of the Test  ................................................................................................. 7 
3.1 Main purpose ............................................................................................................................................... 7 
3.2 Secondary purposes ..................................................................................................................................... 7 
IV. Methodology  .............................................................................................................. 8 
4.1 Overall design of the test ............................................................................................................................. 8 
4.2 Sample size ................................................................................................................................................... 8 
4.3 Random (according to the actual design of the study) ................................................................................. 8 
4.4 Control and blind method (selected according to the actual design of the study) ........................................ 8 
4.5 Interview time point (selected according to the actual design of the study) ................................................. 9 
V. Subject selection, withdrawal and management  ......................................................... 9 
5.1 Diagnostic criteria ....................................................................................................................................... 9 
5.2 Inclusion criteria .......................................................................................................................................... 9 
5.3 Exclusion criteria ......................................................................................................................................... 9 
5.4 Elimination and exit criteria ...................................................................................................................... 10 
Conditions for termination of the test in 5.5 .................................................................................................... 11 
VI. Experimental process (selected according to the actual design of the study)  ......... 12 
6.1 Introduction of test drugs/instruments ....................................................................................................... 12 
6.2 Medication/instrumentation ....................................................................................................................... 12 
6.3 Course of treatment and visit points ........................................................................................................... 12 
VII. EVALUATION INDICATORS ............................................................................... 13 
7.1 Baseline indicators ..................................................................................................................................... 13 
7.2 Effectiveness evaluation ............................................................................................................................. 13 
7.3 Safety evaluation ........................................................................................................................................ 13 
VIII. Data quality assurance .......................................................................................... 15 
8.1 Quality control and assurance ................................................................................................................... 15 

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8.2 Data management ...................................................................................................................................... 15 
IX. STATISTICAL ANALYSIS ...................................................................................... 15 
9.1 Analyzing the data set ................................................................................................................................ 15 
9.2 Statistical methods ..................................................................................................................................... 15 
X. Ethical requirements and informed consent .............................................................. 16 
XI. Insurance (based on risk selection studies) ............................................................... 16 
XII. REFERENCES ....................................................................................................... 16 
Annex 1: Clinical trial flow chart ....................................................... 错误!未定义书签。 

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一、scenario summary 
project 
name 
Comparison of digital and traditional impressions in the absence of dental 
scanning 
version number 
1 .2 
Version date 
2 0250914 
Applications and 
Participating units 
Department of Oral Implantology, Ninth Peoples Hospital affiliated to Shanghai 
Jiao Tong University School of Medicine 
Nature of study 
Randomized controlled 
li i
l
i l
sample capacity 
2 4 
purpose of research 
The passive positioning of restorations, complications within six months, and 
patient evaluation indexes were compared between traditional and digital 
molding methods for fixed restoration of whole arch implants. 
subject investigated 
Patients with full arch implant fixation and restoration 
research technique 
randomized controlled trial 
Inclusion criteria 
Age 3 0-8 0 years old (including 3 0 and 8 0 years old), gender unlimited; 
patients have a segmental permanent fixed restoration of the whole arch on 
the maxilla or mandible; patients have completed bone union after implant 
surgery; patients voluntarily participate in the trial and sign an informed 
t
Exclusion criteria 
The patient had severe pharyngeal reflex; the intermaxillary distance in the 
posterior tooth area was too small to install the molding column; the distance 
between the two implants was too small to install the molding column; the 
patient had temporomandibular joint disease and could not open the mouth for

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Research progress plan 
202 5 July: 
Complete ethical declaration and research registration; 
From   September 202 5 to March 202 6, the screening, enrollment, 
randomization and treatment of 2 4 qualified subjects were 
completed; 
From March 202 6 to September 202 6 , a 6-month follow-up was 
completed for all subjects; 
September 202 6-October 202 6: 
(1) Complete the collation and analysis of all follow-up data; 
statistics 
analytic procedure 
For continuous data with normal distribution, SAS 9.4 is used for 
statistical management and analysis. The "mean ± standard deviation" method 
is employed for descriptive statistics and parameter comparisons, with 
independent samples t-tests. When continuous data deviate from normal 
research findings 
Form of publication 
The research results will be published in international professional 
journals 
Lead researcher 
Lai Hong-
chang
professional 
ranks and
professor date of birth 
1966.11.10 
Item 
eye 
group 
host 
demand 
accomplish 
Officers 
 
surname and 
personal 
date of birth 
professional 
ranks and 
have or not 
GCP 
Division of project work 
Shi Junyu 
1989.5 
physician 
have 
project implementation 
Fu Xiao-
jiao 
1 994.5 
physician 
have 
project implementation 
CAI 
Zhengzhen
1 998.4 
postgraduate not have 
project implementation 
Zhang Xiao 
1 982.7.16 
physician 
have 
statistical analysis 
 
二、research background 
Full-arch implant fixed restoration serves as an effective therapeutic approach for 
reconstructing both aesthetic and functional aspects of the maxillofacial system. The single-
unit titanium bracket restorations require only 4-6 implants to complete, representing a 
common method for edentulous jaw implant fixation. The fabrication of such brackets 

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demands highly precise working models that can replace the need for intraoral implant 
position transfer, facilitating restorative design and processing. Traditional methods and 
digital techniques are employed to obtain working models for edentulous jaw implant 
restoration. Conventional approaches use window-type silicone rubber impressions to transfer 
implant positions before casting plaster models, while digital methods capture implant data 
through optical scanning and generate three-dimensional digital models. Currently, single-
unit titanium bracket restorations are fabricated via digital design and machining. 
Consequently, traditional physical models must undergo comprehensive scanning before 
conversion into digital formats. Direct acquisition of implant positions through digital 
impressions simplifies errors in silicone impression preparation, plaster casting, and model 
house cleaning processes. The precision of digital impressions for edentulous jaw implants 
has been validated through laboratory studies and numerous clinical case reports. Our 
research team previously conducted systematic...Laboratory and clinical studies have 
compared the accuracy of traditional and digital archmolding techniques. Recently, a novel 
intraoral photogrammetric digital archmolding method has been applied for full-arch fixed 
prosthetic titanium bracket archmolding. While preliminary in vitro trials demonstrated 
comparable precision to external photogrammetry, further in vivo clinical trials are still 
required to evaluate its clinical efficacy. This study aims to investigate the archmolding 
accuracy of both digital and traditional methods in full-arch fixed prosthetic applications. 
三、test objective 
3.1 Main purpose 
When a segmental titanium bracket is fixed and restored for the whole arch, the passive positioning of the 
restoration is compared with that of traditional and digital impressions 
3.2 Secondary purposes 
When a segmental titanium bracket is used for fixed restoration of the whole dental arch, the patient 
evaluation index and the doctor evaluation index are compared with those of traditional impression and 
digital impression restoration within half a year 
 

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四、experimental method 
4.1 Overall design of the test 
Randomized, single-blind, single-center, parallel-controlled, non-inferiority trial 
4.2 Sample size 
The pre-test results showed that the clinical score of the control group was 4.22±0.The clinical score 
of the experimental group was 3.875±0.6. A one-sided test was set with a significance level α0.0 5 and a 
power (检验效能) of 80%. The threshold Δwas calculated based on a 1-point difference in clinical scores. 
Using PASS software, the minimum sample size per group was determined to be at least 1 1 cases. 
Considering a 10% dropout rate, the final sample size for each group was set at 1 2 cases, totaling 24 cases. 
 
4.3 Random (according to the actual design of the study) 
Through simple randomization, a randomized number table is generated. The SAS program will be 
stored in the randomization process records to ensure reproducibility of the random number coding. After 
qualified participant screening, researchers assign random numbers. They then sequentially open envelopes 
by drawing numbers, meticulously recording the openers identity and time. Participants are subsequently 
allocated to two groups based on these randomized results. 
4.4 Control and blind method (selected according to the actual design of the study) 
4.4.1 Control selection 
Traditional die removal 
4.4.2 Blind implementation 
This trial blinded the physicians who evaluated the effectiveness of 
the study and the patients who participated in the clinical trial. The 
physicians who evaluated the clinical effectiveness did not know the random 
grouping and followed the routine procedure to evaluate the effectiveness 
of the restoration after placement 

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4.5 Interview time point (selected according to the actual design of the study) 
1 .Take model patients and doctors evaluation 
Passive placement evaluation of stents 
2 .Dentin in restoration T 0 
3 .Denture restoration 3 months T 1 
4 . Denture restoration 6 months T 2 
五、Selection, withdrawal and management of subjects 
5.1 Diagnostic criteria 
The patient had no natural teeth in the arch and was implanted with a prosthesis to carry out 
fixed restoration of the whole arch. 
5 .2. Inclusion criteria 
Age 30-80 years old (including 30 and 80 years old), gender unlimited; 
The patients maxillary or mandibular teeth are planned to be fixed with permanent restoration 
by full arch implantation; 
The patient was implanted with an implant to complete the bone union; 
The patient voluntarily participated in the trial and signed the informed consent form 
5 .3. Exclusion criteria 
The patient had severe pharyngeal reflex; 
The intermaxillary distance of the patients rear tooth area is small and the mold column 
cannot be installed; 
The distance between the two implants is too small to install the take-off column; 
The patient has temporomandibular joint disease, unable to open the mouth for a long time to 
cooperate with the mold taking operation; 
Other patients who were determined by the investigator to be unsuitable for inclusion. 

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5.4 Elimination and exit criteria 
 
5.4.1 Cull criteria 
Those who have been selected into this trial and belong to one of the following conditions shall be 
excluded. 
（ 1） Violation of important entry criteria; 
（ 2） Poor compliance; 
（ 3） No observations were made after randomization. 
5.4.2 Exit criteria 
Subject withdrawal refers to the case in which a selected subject is determined by 
the investigator to withdraw from the trial when it is not appropriate for the 
subject to continue the trial. 
（1） 
In the event of aggravation or deterioration of the condition during the 
trial, emergency measures must be taken; 
（2） 
In the trial, the subject developed certain comorbidities, complications or 
specific physiological changes that make it unsuitable to continue the trial; 
5.4.3 Data processing for withdrawn subjects 
Regardless of the reason, complete clinical data should be retained for participants who withdraw from the 
trial. All withdrawn subjects must complete both the trial conclusion form and the case withdrawal reasons 
section in the Case Report Form. The withdrawal reasons generally fall into six categories: adverse events 
(including drug-related reactions and allergic responses), treatment failure (deterioration of condition or 
complications), protocol violations (poor adherence), loss to follow-up (voluntary withdrawal), sponsor 
discontinuation, or other valid reasons. 
 

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Conditions for discontinuation of the trial at 5.5 
 
（ 1） Trial termination refers to the complete suspension of a clinical trial before its completion as 
planned. 
（ 2） If serious safety problems occur in the test, it should be stopped in time; 
（ 3） In the experiment, it is found that there are major mistakes in the formulation of the test plan or 
major deviations in the implementation, which makes it difficult to evaluate the drug effect; 
（ 4） Other circumstances requiring suspension. 
 
5.6 Subject management 
5.6.1 Subjects recruitment methods 
This study will screen subjects from a continuous patient population at the Department 
of Oral Implantology, Ninth Peoples Hospital affiliated with Shanghai Jiao Tong 
University School of Medicine. One researcher will provide information about the study 
to potentially eligible patients and solicit informed consent from interested subjects 
5.6.2 Informed consent process 
Prior to initiating any study procedures, participants must personally sign the latest 
approved version of the informed consent form with a date. Researchers will provide 
written consent documents to patients and conduct verbal explanations. After confirming 
eligibility criteria, participants will be enrolled in the study and sign the informed 
consent form, after which all research-related procedures and operations may proceed. 
Researchers must provide participants with comprehensive information about the study, 
including: the exact nature of the research; the study protocols impacts and limitations; 
known side effects and risks associated with participation. Participants are explicitly 
informed that they may withdraw from the study at any time for any reason, without being 

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required to provide reasons for withdrawal. Their right to participate in medical 
treatment and the quality of care will not be compromised as a result. 
六、Test process (selected according to the actual design of the study) 
6.1 Introduction of test equipment 
Endoscopic photogrammetry: it is a new type of equipment which uses the principle of 
photogrammetry and digitizes the endoscopic scan to obtain the three-dimensional position of 
implants. It has the characteristics of high precision and high efficiency in vitro research. 
6.2 Instrumental methods 
Intraoral photogrammetry: The shining Elite intraoral scanner was used. Before use, ensure 
that the calibration is within the date. First, scan the gums, then perform intraoral 
photogrammetry, and then merge the data of both. 
 
6 .3 treatment courses and visit points 
(1) Sign the informed consent form; 
(2) Imaging examination of bone union of implant, percussion and stability examination; 
(3) Examination of the patients mouth opening and space for posterior tooth 
restoration, pharyngeal reflex test using intraoral scanner, and taking photos to 
record the condition of the mouth; 
(4) Preparation of traditional silicone rubber windowed clasp mold and digital 
scanning mold, patient evaluation and doctor evaluation; 
(5) According to the random grouping situation, a one-piece titanium bracket 
restorations were made according to the corresponding impression data; 
(6) Try on a segmental titanium stent in the mouth, and conduct clinical scoring of 
stent insertion and X-ray examination; 
(7) After proper trial wearing of the bracket, complete the subsequent processing of 
the restoration. After the completion of wearing the restoration, the secondary screw 
is re-applied to 1 5 N.cm。 

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(8) 3 months reexamination, X-ray examination, open the screw hole to check whether 
the secondary abutment screws of the fixed restoration are loose, and reforce the 
secondary screws to 1 5 N. cm。 
(9) In June, the X-ray was examined, and the screw hole was opened to check whether 
the secondary abutment screws of the fixed restoration were loose. The secondary 
screws were re-applied to 1 5 N.cm。 
 
VII. EVALUATION INDICATORS 
7.1 Baseline indicators  
Demographic data: name, sex, age, etc.; 
Physical examination: mouth opening, pharyngeal reflex, temporomandibular joint;  
General clinical data: number of implants, width of keratinized mucosa around implants. 
7.2. Effectiveness evaluation  
7.2.1 Main evaluation index Passive Inlay Score (FVP-R) for a segmental titanium 
abutment of a restoration. 
l 
Alternating finger pressure method to check whether the stent is loosened (0,1) 
l 
Double side single screw test direct vision combined with probing for gaps (0,1) 
l 
All screws were visually combined with probing to see if there was a gap (0,1) 
l 
Screw resistance experiment whether the screw is smooth (0,1) 
l 
Whether there is a gap in the X-ray line (0,1). 
7.2.2 Secondary evaluation indicators 
Patient evaluation index and doctor evaluation index during sampling 
1、Patient evaluation index 
Comfort score, tension score, pain score, nausea score 
Doctor evaluation index 
Scoring the ease of installation of scanning/transfer rods during the mold removal 
process, scoring the fluency of the mold removal process (fluency of individual tray 

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positioning/scanning), scoring the impact of patient response on the doctors operation 
(pharyngeal reflex/open mouth), and scoring the doctors tension. 
2、time 
Time to wear a tooth 
Time to adjust jaw 
3、function evaluation 
1、Mouthstick test 
2、Voice Evaluation V AS 
3、Smile aesthetics evaluation V AS 
4、Stability of repair (yes/no) 
3. Complications (dental baseline, 3 months and 6 months): 
BIOLOGICAL COMPLICATIONS: 1. Imaging: MBL 
2. Probing: BOP, PD, PL, MH 
3. Soft tissue cracking, soft tissue hyperplasia and hypertrophy, bridge soft 
tissue inflammation 
4. Peri-implant disease 
Mechanical complications: 1. Screw fracture, screw loosening 
2. The sealing material falls off 
3. Broken repair materials, etc 
 
             
4. Satisfaction evaluation 
Patient satisfaction questionnaire (when wearing teeth) 
OHIP-14 questionnaire (3 and 6 months) 
         
7.3 Safety evaluation 
adverse event 
(1) Definitions 
Complication rate (at each visit): the segmental titanium stent was not in place, or 
the stent and screw were broken. 
(2) Recording of adverse events 
During the trial, the adverse event record form should be filled in truthfully, recording the occurrence 
time, severity, duration, effective measures taken and outcome of the adverse event. 

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VIII. Data quality assurance 
8.1 Quality control and assurance 
All participants in the study will receive standardized training on the steps of the 
study, including questionnaires, blood sample collection and storage, preoperative 
examinations and treatments, and implementation of interventions. 
8.2 Data management 
The primary data will be stored and retrieved from Shanghai Ninth Peoples Hospital. 
After analyzing data retrieved from the main databases, participants will be 
identified through specific participant numbers and/or codes in supplementary 
databases. CRF forms will be in written format, with identifiers removed and 
identification codes assigned. These codes will be securely stored separately from 
the data. Names and any other identifying details will not be included in electronic 
files of supplementary research data. All documents will be securely stored and 
accessible only to authorized personnel. Researchers will archive original files, 
informed consent forms, and patient questionnaires for each participant. 
Additionally, researchers will maintain a list of enrolled participants to facilitate 
matching with Case Report Forms (CRFs), clinical records, X-ray films, intraoral 
scanning images, and clinical specimens. 
IX. STATISTICAL ANALYSIS 
9.1 Analyzing the data set 
ITT set (intended treatment analysis set), PP set (analysis set in accordance with the protocol) 
9.2 Statistical methods 
Statistical analysis was performed using SAS9.4 software. All statistical tests in this study employed one-
sided methods, with P values below 0.05 considered statistically significant. Data were described using 
"mean ± standard deviation" and compared through parametric tests, specifically the independent samples t-
test. For non-normal distribution of continuous data, median-based analyses were conducted alongside non-
parametric methods, with the WILCOXON rank sum test employed for comparisons. 

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X. Ethical requirements and informed consent 
10.1 Ethics Committee review  
This protocol, written informed consent documents, and materials directly related to participants must 
be submitted to the ethics committee. The study may only commence after obtaining written approval from 
the ethics committee. Investigators are required to submit annual reports to the ethics committee at least 
once per year (if applicable). When suspending or concluding a study, investigators must notify the ethics 
committee in writing. All changes made during the study (such as revisions to the protocol and/or informed 
consent documents) must be promptly reported to the ethics committee and shall not be implemented 
without prior approval, except for modifications aimed at eliminating clear and direct risks to participants. 
In such cases, the ethics committee will be notified immediately.  
10.2 Informed consent 
Researchers must provide subjects or their legal representatives with an easily understandable and 
ethics committee-approved informed consent form, allowing sufficient time for them to review the study 
details. Participants may not be enrolled until they have signed the written consent. Throughout the study 
period, all updated versions of the informed consent form and related documentation will be provided to 
participants. The consent form shall be retained as a critical clinical trial record for future reference. 
 
XI. Insurance (based on risk selection studies) 
not have 
XII. REFERENCES 
1. Maló P, de Araújo Nobre M, Lopes A, Ferro A,  Gravito I. All-on-4® Treatment Concept for the 
Rehabilitation of the Completely Edentulous Mandible: A 7-Year Clinical and 5-Year Radiographic 
Retrospective Case Series with Risk Assessment for Implant Failure and Marginal Bone Level. Clin 
Implant Dent  Relat Res. 2015;17  Suppl2:e531-41.  

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2. Tang Y, Yu H, Wang J,  Qiu L. Implant Survival and Complication Prevalence in Complete-Arch Implant-
Supported Fixed Dental Prostheses: A Retrospective Study with a Mean Follow-up of 5 Years. Int J Oral  
Maxillofac Implants.2023;38:84-93. 
3. Di Fiore A,  Meneghello R,  Graiff L,  Savio G,  Vigolo P, Monaco C et al. Full arch digital scanning 
systems performances for implant-supported fixed dental prostheses: a comparative study of 8 intraoral 
scanners. J  Prosthodont Res. 2019;63:396-403.