| CTRI Number |
CTRI/2025/12/098747 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of soft tissue changes and implant position with scannable gingiva modifier component. |
|
Scientific Title of Study
|
Influence of oral mechanical and biological factors in altering the scannable accuracy of coded healing abutments at different time periods in comparison with implant scan body - A randomised controlled trial accuracy of coded healing abutments at different time periods in comparison with implant scan body – A randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonakshi K |
| Designation |
Postgraduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
S2, 49 AGS Office Staff Colony, Alwarthirunagar, Chennai
Chennai TAMIL NADU 600087 India |
| Phone |
9952539548 |
| Fax |
|
| Email |
drsonakshikaruppasami@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr V Anand Kumar |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
51/8, Soundharya colony, Anna Nagar West Extn, Chennai
Chennai TAMIL NADU 600101 India |
| Phone |
9444121616 |
| Fax |
|
| Email |
anand_anandhi@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr V Anand Kumar |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
51/8, Soundharya colony, Anna Nagar West Extn, Chennai
Chennai TAMIL NADU 600101 India |
| Phone |
9444121616 |
| Fax |
|
| Email |
anand_anandhi@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Room No.8, PG Clinic Department of prosthodontics, implantology, Sri Ramachandra Dental College and Hospital, Porur, Chennai 600116 |
|
|
Primary Sponsor
|
| Name |
Sonakshi K |
| Address |
S2, 49 , AGS Office Staff Colony, Alwarthirunagar, Chennai 87 |
| 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 |
| Dr V Anand Kumar |
Sri Ramachandra Institute of Higher Education and Research |
Sri Ramachandra Dental College, Room No.8, Department of prosthodontics, implantology, PG Clinic Chennai TAMIL NADU |
9444121616
anand_anandhi@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient having mandibular edentulous space willing for replacement through dental implants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
scan body |
The accuracy of scannable healing abutments and scan body is evaluated |
| Comparator Agent |
scannable healing abutment for 21 days |
Scannable healing abutments are placed after implant placement and digital impression is made on the 21st day |
| Comparator Agent |
Scannable healing abutment for 60days |
Scannable healing abutments are placed after implant placement and digital impression is made on the 21st day and 60th day |
| Intervention |
Scannable healing abutment for 90days |
Scannable healing abutments are placed after implant placement and digital impression is made on the 21st day, 60th day and 90th day |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Absence of systemic diseases that will affect bone metabolism and wound healing.
Missing mandibular posteriors that requires rehabilitation with implants.
Keratinized mucosa of minimal thickness of 2mm.
Non smokers
|
|
| ExclusionCriteria |
| Details |
History of Diabetes and Bleeding disorders
History of radiotherapy and chemotherapy
Severe acute or chronic periodontitis
Psychiatric problem
Drug abuse
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the accuracy of scannable healing abutments with scan bodies, comparing the coronal and apical deviation of the dental implant position.
|
DAY 0, DAY 21, DAY 60, DAY 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in soft tissue contouring using digital impression
Evaluate the surface roughness of the post usage scannable healing abutment
Evaluate the salivary zeta potential & correlate with the surface roughness around the scannable healing abutment.
|
Using digital scan & SEM analysis on DAY 21, DAY 60, DAY 90 for the respective groups |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
22/12/2025 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Scannable healing abutments are advanced dental implant components designed with specific surface codes or unique anatomical shapes which allow them to be detected directly by intraoral scanners. This enables accurate digital capture of implant position, size, and orientation without the need to remove and replace the abutment for separate scan bodies or impression components. Integrating these abutments into the treatment workflow not only helps shape and maintain the soft tissue contour during the healing phase, but also supports a precise and efficient transition to digital impressions. The result is an accelerated, more accurate, and more comfortable clinical procedure for both patient and clinician. Scannable healing abutments minimize the risk of distortion typical of traditional impressions, reduce the number of necessary appointments, and allow seamless CAD CAM fabrication of prosthetic components.
As the use of digital workflows in implant dentistry becomes increasingly prevalent, scannable healing abutments have been widely adopted for guided surgery and fully digital restorative protocols. Their use allows practitioners to eliminate the repeated disconnection and reconnection of abutments. These practices that may otherwise risk soft tissue or bone disturbance.
However, clinical observations and studies have highlighted some challenges with these abutments. When left intraorally for extended periods, scannable healing abutments are prone to the accumulation of plaque and calculus as well as adherence of biological debris. Upon removal, these abutments frequently display visible scratches and areas of discoloration. These surface alterations may result from daily oral function, mechanical wear, and the exposure to oral fluids and microbial biofilms. While scannable healing abutments are intended to simplify digital impressions and optimize soft tissue outcomes, it remains unclear whether such surface changes compromise the accuracy of digital scans.
Crucially, there is limited research exploring how nonfunctional loading, plaque accumulation, and surface modifications during intraoral use might alter the clinical performance of scannable healing abutments. Understanding these aspects is important to ensure that the long term accuracy of digital impressions is maintained and that optimal restorative outcomes can be consistently achieved. Further studies are needed to clarify the impact of these surface changes and to establish best practices. |