| CTRI Number |
CTRI/2024/08/072752 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison of 3D Implant Impression Accuracy Between Traditional and Digital Methods Using Two Different Intraoral Scanners: An In Vivo Study |
|
Scientific Title of Study
|
Comparative Evaluation Of the 3 Dimensional Implant Impression Accuracy Between Conventional and Digital Impression Using Two Different Intraoral Scanners:- An In Vivo Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Ranjan |
| Designation |
MDS(Postgraduate ) |
| Affiliation |
ITS Dental College Hospital And Research Centre, Greater Noida |
| Address |
Room no. 6 , Department Of Prosthodontics , Crown and Bridges And Maxillofacial Prosthesis, ITS Dental College Hospital And Research Centre, 47, Knowledge Park III , Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9560024281 |
| Fax |
|
| Email |
rahul.ranjan94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anju Aggarwal |
| Designation |
Professor |
| Affiliation |
ITS Dental College Hospital And Research Centre, Greater Noida |
| Address |
Room no. 6 , Department Of Prosthodontics , Crown and Bridges And Maxillofacial Prosthesis, ITS Dental College Hospital And Research Centre, 47, Knowledge Park III , Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
8800201519 |
| Fax |
|
| Email |
anjuagarwal@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anju Aggarwal |
| Designation |
Professor |
| Affiliation |
ITS Dental College Hospital And Research Centre, Greater Noida |
| Address |
Room no. 6 , Department Of Prosthodontics , Crown and Bridges And Maxillofacial Prosthesis, ITS Dental College Hospital And Research Centre, 47, Knowledge Park III , Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8800201519 |
| Fax |
|
| Email |
anjuagarwal@its.edu.in |
|
|
Source of Monetary or Material Support
|
| Room no. 6, Department Of Prosthodontics Crown And Bridges And Maxillofacial Prosthesis, ITS Dental College Hospital And Research Centre, 47, Knowledge Park III, Greater Noida, Gautam Buddha Nagar, 201308, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
ITS Dental College Hospital And Research Centre |
| Address |
Room no. 6, Department Of Prosthodontics Crown And Bridges And Maxillofacial Prosthesis, ITS Dental College Hospital And Research Centre, 47, Knowledge Park III, Greater Noida |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul Ranjan |
ITS Dental College Hospital And Research Centre |
Room no. 6, Department Of Prosthodontics Crown And Bridges And Maxillofacial Prosthesis, ITS Dental College Hospital And Research Centre, 47, Knowledge Park III, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9560024281
rahul.ranjan94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS Dental College Hospital And Research Centre Institutional ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient With missing teeth (Partially edentulous) willing for implant placement |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional implant impression |
a conventional impression will be taken by Addition silicone impression material |
| Comparator Agent |
Digital implant impression |
Digital implant impression will be taken with the help of another intraoral scanner i.e. CEREC Primescan (Dentsply sirona®) |
| Comparator Agent |
Digital implant impression |
Digital implant impression will be taken with the help of one of the intraoral scanner i.e. Aoralscan 3 (Shining 3D) |
| Comparator Agent |
Reference Model |
Reference model will be made by same procedure for each patient.
Two implant impression copings will be splinted with autopolymerizing acrylic resin (Pattern Resin).
To standardize the amount of splinting material for all instances, the dimension of the splinted assembly will be kept to 4 mm high and 2 mm wide.
To verify the precise splinting procedure, the splinted assemblies will be sectioned through the middle of the index, and will be rejoined again with freshly mixed pattern resin material by the brush bead method. Then, the splinted assembly will be allowed to completely set prior to impression making.
A periapical x-ray will be taken for every patient to confirm the complete seating before transferring it for impression making. After that, the splinted assembly will be removed, and analogs of the same size for all cases will be attached and hand tightened. They will then seated immediately in wet gypsum product. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Two simultaneously placed implants
2.Healthy periodontium
3.Adequate mouth opening.
|
|
| ExclusionCriteria |
| Details |
1.Patients with smoking or tobacco chewing habits
2.Patients with limited mouth opening
3.Patients not willing to participate in study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To comparatively evaluate 3 Dimensional implant impression accuracy between conventional and digital impression techniques |
within 1 month of impression taking |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate 3 Dimensional implant impression accuracy with conventional impression technique.
2.To evaluate 3 Dimensional implant impression accuracy with digital technique using two different intraoral scanners.
|
within 1 month of impression taking |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be done to evaluate 3 dimensional implant impression accuracy between conventional and digital impression using two different intraoral scanners. The forthcoming in vivo study will be conducted in the department of Prosthodontics, Crown and Bridge , Maxillofacial Prosthodontics and Oral Implantology, I.T.S Dental College, Hospital and Research Centre, Greater Noida (U.P) Patients of both genders aged from 18 years of age , who will be reporting to the department of Prosthodontics, Crown and Bridge , Maxillofacial Prosthodontics and Oral Implantology, I.T.S Dental College will serve as the source for the data collection. A total of 10 patients with already placed implants will be the subjects for study. I. Reference Model Fabrication A Reference model will be made for each patient which will be serve as control for study. Reference model will be made by same procedure for each patient. First, the healing abutments will be removed, and two square impression copings (4 mm diameter × 17 mm height;) will be hand tightened. The two impression copings will be splinted with autopolymerizing acrylic resin (Pattern Resin;). To standardize the amount of splinting material for all instances, the dimension of the splinted assembly will be kept to 4 mm high and 2 mm wide; this amount of material could also prevent any distortion during the implant analog attaching procedure. To verify the precise splinting procedure, the splinted assemblies will be sectioned through the middle of the index, and will be rejoined again with freshly mixed pattern resin material by the brush bead method. Then, the splinted assembly will be allowed to completely set prior to impression making. A periapical x-ray will be taken for every patient to confirm the complete seating before transferring it for impression making. After that, the splinted assembly will be removed, and analogs of the same size for all cases will be attached and hand tightened. They will then seated immediately in wet gypsum product. To homogenize the impression making procedure, the gypsum powder and distilled water will used to produce each reference model. After the stone will completely set, the splinted impression copings will be removed from the analogs. This fabricated model with the two analogs inside will be considered as the reference model (RM) in this study. For every participant, the RM will be first obtained with the same procedure as previously mentioned I. Conventional implant impression technique and cast fabrication II. Digital implant impression using two different intraoral scanners i.e. Aoralscan 3 (Shining 3D) & CEREC Primescan (Dentsply sirona®). Two scanners ( Primescan & Aoralscan 3 ) will be used for intraoral scanning & addition silicone impression material will be used for conventional impression technique. A master cast will be poured with Types 4 gypsum product for conventional impression and will be scanned. An Industrial scanner will be used for scanning Reference model. III. Measurements All 3 STL files ( two intraoral scanner & one master model) will be superimposed with Reference model STL file and Interimplant distance deviation (2D) and coordinates (x, y, z), will be assessed and compared among the two approaches. All the data will be collected and Overall intergroup comparison among three groups will be done using One-way Anova ‘F’ test followed by Tukey’s post hoc test for pairwise intergroup comparison between each groups.
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