CTRI

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CTRI Number

CTRI/2026/03/105225 [Registered on: 02/03/2026] Trial Registered Prospectively

Last Modified On:

20/02/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Randomized, Parallel Group Trial

Public Title of Study

It compares scanner and traditional impression to see which gives a better fitting denture in real patients

Scientific Title of Study

Comparative evaluation of deviation in denture base area of completely edentulous arches recorded using digital and conventional impression technique- 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. Pinky sah
Designation	Junior resident
Affiliation	All India institute of medical sciences
Address	2nd floor, department of prosthodontics, Center for dental education and research, All India institute of medical sciences,Sri Aurobindo garg,Ansari Nagar,New delhi South DELHI 110029 India
Phone	9773803094
Fax
Email	Pinkysah802@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Veena jain
Designation	Head and professor
Affiliation	All India institute of medical sciences
Address	2nd floor, department of prosthodontics, Center for dental education and research, All India institute of medical sciences,Sri Aurobindo garg,Ansari Nagar,New delhi South DELHI 110029 India
Phone	9868187441
Fax
Email	Veenajain1@gmail.com

Details of Contact Person
Public Query

Name	Pinky Sah
Designation	Junior resident
Affiliation	All India institute of medical sciences
Address	2nd floor, department of prosthodontics, Center for dental education and research, All India institute of medical sciences,Sri Aurobindo garg,Ansari Nagar,New delhi South DELHI 110029 India
Phone	09773803094
Fax
Email	Pinkysah802@gmail.com

Source of Monetary or Material Support

Pinky sah ,junior resident, Department of prosthodontics, Center for dental education and research, AIIMS

Primary Sponsor

Name	Pinky sah
Address	Second floor, Department of prosthodontics,Center for dental education and research, All India institute of medical sciences, sri Aurobindo garg,Ansari Nagar east, New Delhi.
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
Nil	Nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Pinky sah	Center for dental education and research	Second floor,department of prosthodontics, Center for dental education and research,sri Aurobindo garg,Ansari Nagar east,New delhi South DELHI	09773803094 Pinkysah802@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institute of ethics committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Complete loss of teeth

Intervention / Comparator Agent

Type	Name	Details
Intervention	Digital impression technique	To record the denture base area of edentulous arches (maxilla and mandible)and compare it with conventionally recorded impression.
Comparator Agent	Digital impression technique	To record the denture base area of edentulous arches (maxilla and mandible)and compare it with digitally recorded impression

Inclusion Criteria

Age From	24.00 Year(s)
Age To	90.00 Year(s)
Gender	Both
Details	1. Completely edentulous maxillary and mandibular arches 2. Healthy mucosa 3. Healthy systemic condition

ExclusionCriteria

Details

1. Patient with flabby ridges,
2. Presence of any teeth,
3. Limited mouth opening,
4. Refusal to sign the informed consent.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
To compare the deviation in denture base area of edentulous arches recorded using digital and conventional impression technique.	At first visit

Secondary Outcome

Outcome	TimePoints
1. To evaluate the patient preference in both digital & conventional impression technique. 2. To record the time taken in both digital & conventional impression technique.	No follow up

Target Sample Size

Total Sample Size="28"
Sample Size from India="28"
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

Phase 2

Date of First Enrollment (India)

15/03/2026

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="10"
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

This study compares conventional and digital impression techniques for edentulous arches. Conventional impression though widely used, have some limitation such as material distortion, tray selection issues, and storage problems. Digital impression using intraoral scanner offer advantages like improved patient comfort, immediate visualization, and CADCAM integration, but are limited by high cost, need for training, and difficultly in capturing movable tissue.

So this study is planned to compare the impression of edentulous arches recorded using digital and conventional impression technique.