| 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
|
|
|
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
|
|
|
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
|
|
|
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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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: - Age – between 18-50 years
- Requirement for a single full-coverage crown on a mandibular first molar
- Periodontally healthy (Whole mouth bleeding sites <10%, full mouth plaque score (FMPS) <20%, no loss of attachment)
- 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.
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. |