| CTRI Number |
CTRI/2026/03/106259 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of soft tissue healing around Dental Implants |
|
Scientific Title of Study
|
Comparative evaluation of soft tissue health around standardized titanium healing abutment and customized healing abutments of the dental implants - a randomized controlled clinical 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 |
Dr Samiksha Pandare |
| Designation |
pg student |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences |
| Address |
Department of Implantology KLE VK Institue of Dental Sciences nehru nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
7823066191 |
| Fax |
|
| Email |
samikshayogesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta S Hugar |
| Designation |
Reader |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences |
| Address |
KAHERs KLE VK Institue of Dental Sciences nehru nagar belagavi karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9481703314 |
| Fax |
|
| Email |
shweta.hugar.12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samiksha Pandare |
| Designation |
pg student |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences |
| Address |
Department of Implantology KLE VK Institue of Dental Sciences nehru nagar belagavi karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
7823066191 |
| Fax |
|
| Email |
samikshayogesh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Samiksha Pandare |
| Address |
KAHERs KLE VK Institute of Dental Sciences nehru nagar Belagavi 590010 |
| Type of Sponsor |
Other [KAHERs KLE VK Institute of Dental Sciences] |
|
|
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 Samiksha Pandare |
KAHERs KLE VK Institute of Dental Sciences Belagavi |
Department of Implantology
Belgaum
KARNATAKA |
7823066191
samikshayogesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Research and Ethical Committee KLE VKIDS NECRBHR, DHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patient with implant prosthesis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Customized Healing Abutment |
After surgical placement of the dental implant under local anesthesia using standard implant protocol a customized healing abutment will be fabricated and placed to provide an individualized emergence profile supporting peri-implant soft tissues. The customized healing abutment will remain in oral cavity during the healing phase. Peri-implant soft tissue health will be evaluated at 2 weeks, 4 weeks, and 12 weeks using Gingival Index, Plaque Index , Healing Index and at baseline and 6 weeks using digital 3D superimposition analysis. |
| Comparator Agent |
standardized Titanium Prefabricated Healing Abutment |
After surgical placement of the dental implant under local anesthesia using standard implant protocol (Osstem implant system), a standardized prefabricated titanium healing abutment will be placed immediately. The healing abutment will remain in situ during the healing phase. Peri-implant soft tissue health will be evaluated at 2 weeks, 4 weeks, and 12 weeks using Gingival Index , Plaque Index , Healing Index and at baseline and 6 weeks using digital 3D superimposition analysis. |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients age between 22 years – 60 years require implant for missing teeth.
Patients those are systemically healthy.
Patients with healing abutment placed during II stage surgery.
Patients who are willing to participate in the study and give written consent.
|
|
| ExclusionCriteria |
| Details |
Participants who do not give written consent.
Patients with systemic diseases
Patients who are smokers or tobacco users.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Gingival Index Löe & Silness
Plaque Index Silness & Löe
Healing Index Landry et al |
2 weeks 4 weeks 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Digital 3D superimposition for gingival height and width changes |
baseline and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2026 |
| 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="6"
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 randomized controlled clinical trial aims to compare peri-implant soft tissue health around standardized titanium healing abutments and customized healing abutments in 52 implant sites. Participants will be randomly allocated into two equal groups. Clinical parameters including gingival index, plaque index, healing index, width and thickness of keratinized tissue, and digital 3D analysis will be recorded at 2, 4, and 12 weeks. The study intends to evaluate whether customized healing abutments provide superior soft tissue outcomes compared to standardized healing abutments |