| CTRI Number |
CTRI/2026/02/104409 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study comparing bone loss and gum changes in immediate implant placement with and without bone graft using a modified healing cap in the upper premolar region |
|
Scientific Title of Study
|
Comparative evaluation of crestal bone loss and pink esthetic score in immediate implant placement with and without bone grafting using socket seal abutments in maxillary premolar region: An in-vivo split mouth study. |
| 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 Devang Bansal |
| Designation |
Postgraduate student |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences |
| Address |
Dept of Prosthodontics And Crown & Bridge, KAHERs KLE VK Institute of Dental Sciences, Nehru Nagar,
Belgaum.
Belgaum
KARNATAKA
590010
India |
| Phone |
9595599159 |
| Fax |
|
| Email |
devangbansal1107@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapnil Shankargouda |
| Designation |
Reader |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences |
| Address |
Dept of Prosthodontics And Crown & Bridge, KAHERs KLE VK Institute of Dental Sciences, Nehru Nagar,
Belgaum.
Belgaum
KARNATAKA
590010
India |
| Phone |
9986815280 |
| Fax |
|
| Email |
swapnilshankargouda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devang Bansal |
| Designation |
Postgraduate student |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences |
| Address |
Dept of Prosthodontics And Crown & Bridge, KAHERs KLE VK Institute of Dental Sciences, Nehru Nagar,
Belgaum.
Belgaum
KARNATAKA
590010
India |
| Phone |
9595599159 |
| Fax |
|
| Email |
devangbansal1107@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Devang Bansal |
| Address |
KAHERs KLE VK Institute of Dental Sciences, Nehrunagar, Belagavi |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Devang Bansal |
KAHERs KLE VK Institute of Dental Sciences, Belagavi |
Dept of Prosthodontics and Crown & Bridge, KAHERs KLE VK Institute of Dental Sciences, Nehrunagar, Belagavi
Belgaum
KARNATAKA |
9595599159
devangbansal1107@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee, KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Immediate Implant Placement with bone grafting |
Application of the dual-zone bone grafting concept in immediate implant placement in the maxillary premolar region |
| Comparator Agent |
Immediate Implant placement without bone grafting |
Immediate implant placement without application of the bone grafting (nongrafted sites) in maxillary premolar region. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients requiring tooth extraction and immediate implant placement in the maxillary premolar region, present in the esthetic zone.
2. Extraction socket classified as Type I [Elian et al], which is the presence of an intact facial (buccal) cortical plate with no clinical or radiographic evidence of dehiscence or fenestration.
3. Teeth with no active periapical pathology and gingival inflammation.
4. Presence of adjacent sound natural teeth without caries, trauma, or tooth surface loss.
5. Teeth with a minimum of 3 mm palatal/apical bone/interradicular bone to facilitate implant placement.
6. Patients willing to participate in the study and provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Extraction sockets classified as Type II or Type III [Elian et al] according to the socket classification system, indicating compromised facial bone integrity.
2. Teeth with active periapical pathology and gingival inflammation.
3. Patients who have a habit of smoking and chewing tobacco or parafunctional habits.
4. Patients having systemic diseases like uncontrolled diabetes, hypertension and bleeding disorders and also with bisphosphonate therapy.
5. Pregnant women, lactating mothers and also patients who underwent radiation therapy less than a year ago.
6. Patients with poor oral hygiene, poor compliance, and those who are not willing to undergo treatment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Crestal bone loss (CBL): Assessed using CBCT to evaluate peri-implant bone loss in grafted and nongrafted sites. |
Immediate postoperatively, 3 month and 6 months postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pink Esthetic Score (PES): Evaluated clinically to assess peri-implant soft-tissue esthetics and gingival contour around immediate implants with and without bone grafting. |
Preoperatively, immediate postoperatively, 3-month, and 6-month postoperatively |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
02/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
This in-vivo split-mouth clinical study which aims to compare crestal bone loss and pink esthetic score in immediate implant placement with and without application of the bone grafting concept using socket seal abutments in the maxillary premolar region. CBCT will be used to evaluate crestal bone levels, immediately postoperatively, and at 3 and 6 months. Also pink esthetic score will be evaluated preoperatively, immediately postoperatively, and at 3 and 6 months postoperatively. The findings are intended to determine whether bone grafting provides additional benefits over graftless sites in preserving peri-implant bone and soft-tissue esthetics in the maxillary premolar region. |