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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  
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 
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  
Status 
Not Applicable 
 
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.
 
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