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CTRI Number  CTRI/2025/10/095921 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On: 11/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparing digital and traditional methods for precise capturing of deep tooth margins 
Scientific Title of Study   Accuracy of Subgingival Finish Line Reproduction in Intraoral Scanning Versus Conventional Impressions: A Prospective Clinical Study With and Without Gingival Retraction 
Trial Acronym  IOS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prajakta Raghudas Volvaikar 
Designation  Resident, M.D.S. Prosthodontics 
Affiliation  Goa Dental College and Hospital 
Address  Department of Prosthodontics, Goa Dental College and Hospital, Rajiv Gandhi Medical Complex, Bambolim, Goa,India.

North Goa
GOA
403202
India 
Phone  9922190616  
Fax    
Email  prajakta.volvaikar96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aradhana Nagarsekar 
Designation  Assistant Prosfessor 
Affiliation  Goa Dental College and Hospital 
Address  Department of Prosthodontics, Goa Dental College and Hospital, Rajiv Gandhi Medical Complex, Bambolim, Goa, India.

North Goa
GOA
403202
India 
Phone  9673991500  
Fax    
Email  aradhana.nagarsekar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ridhima Gaunkar 
Designation  Professor 
Affiliation  Goa Dental College and Hospital 
Address  Department of Community Dentistry, Goa Dental College and Hospital, Rajiv Gandhi Medical Complex, Bambolim, Goa, India.

North Goa
GOA
403202
India 
Phone  9326469134  
Fax    
Email  drbirmani@gmail.com   
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Prajakta Raghudas Volvaikar 
Address  Goa Dental College and Hospital, Rajiv Gandhi Medical Complex, Bambolim, Goa, India. 403202 
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 
Prajakta Raghudas Volvaikar  Department of Prosthodontics, Goa Dental College and Hospital  Rajiv Gandhi Medical Complex, Bambolim, Goa, India.403202
North Goa
GOA 
9922190616

prajakta.volvaikar96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Goa Dental College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Impression with/without Gingival Retraction  Conventional impressions will be made using polyvinyl siloxane material (Zhermack Elite HD+, Italy; putty and light body, normal set), two-phase, two-step technique, with a sulcus tip. A polyethylene spacer will be used. The impressions will be poured, and the casts scanned using a laboratory scanner to obtain STL files. Gingival retraction procedure: A single-cord technique will be used. A knitted gingival displacement cord will be placed in the gingival sulcus below the preparation finish line. The cord will be pre-soaked in a hemostatic agent. Frequency and duration: Single impression procedure per participant; total study duration – 1 month. 
Intervention  Digital Impression with/without Gingival Retraction  Digital impressions will be obtained using an intraoral scanner (Allied Star AS 100, Shanghai, China) following the manufacturer’s recommended protocol. Scanning will include the maxillary arch, mandibular arch, and bite registration; all scans saved in STL format. Gingival retraction procedure: Same as comparator – knitted gingival displacement cord placed below the finish line, pre-soaked in a hemostatic agent, single-cord technique. Frequency and duration: Single digital scan per participant; total study duration – 1 month. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Requirement for a single full-coverage crown on a mandibular first molar
Periodontally healthy
General good systemic health
 
 
ExclusionCriteria 
Details  Presence of active infection or severe periodontal inflammation
No restorations in cervical 1/3rd of teeth
History of chronic systemic disease
Current or past smoking habit
Presence of parafunctional habits
 
 
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 
Width and Depth of Subgingival finish line, Amount of Retraction  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   22/10/2025 
Date of Study Completion (India) 14/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

HYPOTHESIS:

The null hypothesis states that the accuracy of subgingival finish line capture is not influenced by the type of impression technique used or the application of subgingival retraction. The research hypothesis states that differences exist in the accuracy of intraoral scanners depending on the impression technique used and the application of gingival retraction.

AIM OF THE STUDY:

The current study aims to evaluate the accuracy of intraoral scanners in recording subgingival finish lines by evaluating the three critical parameters, i.e. the depth and width of the finish line and the extent of gingival retraction of the prepared tooth with and without gingival retraction for fabrication of fixed prostheses in comparison with the conventional impression techniques.

OBJECTIVES:

       To evaluate the accuracy of intraoral scanner in relation to the width of finish line with and without gingival retraction.

       To evaluate the accuracy of intraoral scanner in relation to the depth of finish line with and without gingival retraction.

       To evaluate the amount of gingival retraction.

 

METHODOLOGY:

Study Design:

A Randomised Controlled Trial

 

Study setting: Goa Dental College and Hospital

 

Study population:

Patients indicated for single full crown prosthesis with subgingival finish line


Inclusion Criteria:

  1. Age – between 18-50 years
  2. Requirement for a single full-coverage crown on a mandibular first molar
  3. Periodontally healthy (Whole mouth bleeding sites <10%, full mouth plaque score (FMPS) <20%, no loss of attachment)
  4. General good systemic health

 

Exclusion Criteria:

1. Presence of active infection or severe periodontal inflammation

2.No restorations in cervical 1/3rd of teeth

3. History of chronic systemic disease

4. Current or past smoking habit

5. Presence of parafunctional habits

 

Permissions to be taken:

Written consent will be obtained from patients participating in the study

 


Methodology in brief

Tooth preparation and temporization

Pretreatment radiographs and intraoral photographs will be obtained for all participants. A polyvinyl siloxane putty index will be fabricated for the construction of temporary crowns. Tooth preparation will be performed according to the planned restoration, with a standardized shoulder finish line placed on the buccal surface with all finish lines located 0.5–1.0 mm subgingivally.

The prepared abutments will be temporized with a bis-acrylic resin using non-eugenol temporary cement for a duration of 2 weeks. To avoid tissue fatigue, a minimum interval of 7 days will be maintained between post-displacement impressions within the same participant, following a Latin block design. Periodontal health will be re-evaluated and confirmed before impression making. Four impression techniques will be performed: digital without retraction (DWR), digital with retraction (DR), conventional without retraction (CWR), and conventional with retraction (CR)

Impression procedures

Conventional impressions will be made using polyvinyl siloxane material with a two-phase, two-step technique using a sulcus tip. A polyethylene sheet will be used as a spacer. Casts of conventional impressions will be scanned with a laboratory scanner and STL files generated.


(b)


Intraoral scans

Digital impressions will be obtained using an intraoral scanner following the manufacturer’s recommended protocol. The scanning sequence includes the maxillary arch, the mandibular arch, and bite registration. All scans will be saved in standard tessellation language (STL) format.

Gingival retraction procedure

A knitted gingival displacement cord will be placed in the gingival sulcus below the preparation finish line. The cord will be pre-soaked in a hemostatic agent and inserted using a gingival cord. A single-cord technique will be employed.

 

Measurements and data collection

All STL files will be processed by a single dental master technician using Exocad software. All four STL files will be superimposed using best fit algorithm and sectioned mesiodistally and buccolingually. Measurements were performed at three locations—mid-buccal (B), mesial (M), and distal (D)—by a blinded evaluator. Three linear distances will be recorded: (1) between the most proximal apical and the most distal points of the finish line; (2) between the finish line and the most subgingival part of the tooth; and (3) between the most distal point of the finish line and the gingiva.

Expected Outcome:

The primary outcome is that the accuracy of intraoral scanner will be comparable to conventional impression in recording the subgingival width, depth and amount of retraction. Gingival retraction will improve the accuracy.

 
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