| CTRI Number |
CTRI/2025/04/085712 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Dental implant placement immediately after complete and partial removal of upper premolar teeth and its effect on bone loss and gum esthetics. |
|
Scientific Title of Study
|
Evaluation of marginal bone loss and esthetic outcome for socket shield technique and immediate implant placement in maxillary premolar region. An in-vivo 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 |
pankaj kadam |
| Designation |
post-graduate student |
| Affiliation |
KLE VK institute of dental sciences, belgaum |
| Address |
department of prosthodontics and crown & bridge, KAHERs KLE VK institute of dental sciences, belgaum.
Belgaum
KARNATAKA
590010
India |
| Phone |
7385557842 |
| Fax |
|
| Email |
kadampankaj942@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr. swapnil shankargouda |
| Designation |
reader |
| Affiliation |
KLE VK institute of dental sciences, belgaum |
| Address |
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 |
pankaj kadam |
| Designation |
post-graduate student |
| Affiliation |
KLE VK institute of dental sciences, belgaum |
| Address |
department of prosthodontics and crown & bridge, KAHERs KLE VK institute of dental sciences, nehru nagar, belgaum.
Belgaum
KARNATAKA
590010
India |
| Phone |
7385557842 |
| Fax |
|
| Email |
kadampankaj942@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs KLE V. K. Institute of Dental Sciences, Belagavi-590010, karnataka, india |
|
|
Primary Sponsor
|
| Name |
pankaj kadam |
| Address |
Department of prosthodontics and crown and bridge, KLE V K Institute of dental sciences Belagavi-590010, karnataka, india |
| 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 Pankaj Kadam |
KAHER KLE VK INSTITUTE OF DENTAL SCIENCES,BELAGAVI |
Department of Prosthodontics and Crown and Bridge
Belgaum
KARNATAKA |
07385557842
kadampankaj942@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 |
| Healthy Human Volunteers |
UNRESTORABLE MAXILLARY PREMOLAR TEETH IN ESTHETIC ZONE INDICATED FOR EXTRACTION |
| Patients |
(1) ICD-10 Condition: K083||Retained dental root, (2) ICD-10 Condition: K083||Retained dental root, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IMMEDIATE IMPLANT PLACEMENT TECHNIQUE |
EXTRACTION OF INDICATED TOOTH AND IMMEDIATE IMPLANT PLACEMENT IN MAXILLARY PREMOLAR TEETH WITH FOLLOW UP PERIOD OF 9 MONTHS |
| Intervention |
SOCKET SHIELD TECHNIQUE |
USE OF SOCKET SHIELD TECHNIQUE IN UNRESTORABLE MAXILLARY PREMOLAR TEETH WITH FOLLOW UP PERIOD OF 9 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Teeth indicated for extraction and which cannot be restored.
2 Teeth with healthy periodontal status with no gingival inflammation or bone loss.
3 Adequate palatal/lingual and apical bone for implant placement.
4 Favorable occlusal scheme for immediate provisional and definitive restoration.
5 For multirooted teeth, having large interradicular bone.
6 All patients included in the study should have one missing posterior tooth, with adjacent or contralateral sound natural teeth without any carious lesions, trauma or wasting disease.
7 Patients who are willing to involve in the study.
|
|
| ExclusionCriteria |
| Details |
1 Mobile teeth.
2 Teeth with thin or absence of labial and palatal bone.
3 Teeth with larger periapical infection or any active lesion.
4 Vertical root fracture.
5 Internal resorption.
6 Patients having habit of smoking and chewing tobacco.
7 Patients having systemic diseases like uncontrolled diabetes, hypertension and bleeding disorders.
8 Patients who are not physically fit for the treatment as consulted by the physician.
9 Pregnant woman and lactating mothers.
10 Patients who have undergone radiation therapy.
11 Patients with parafunctional habits, restored adjacent or contralateral tooth, or acute infection at the implant region.
12 Patients who are not willing to involve in the
study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is no change in marginal bone loss and aesthetic outcome in socket shield technique and immediate implant placement in maxillary premolar region |
baseline 3 months 6 months 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is no change in maginal bone loss & aesthetic outcome in socket shield technique & immediate implant placement in maxillary premolar region at the end of 9 months. |
at the end of 9 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2025 |
| Date of Study Completion (India) |
30/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
The purpose of the study is to rehabilitate the petients tooth with dental implants and maintain periimplant bone and soft tissue. Participants will be selected based on the patients dental health and will be treated with one of the two techniques that is either socket shield technique or immediate implant placement technique depending upon the retained dental root which is previously indicated for extraction. |