| CTRI Number |
CTRI/2025/01/079203 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Soft Tissue And Crestal Bone Loss Analysis Around Dental Implant With And Without T-PRF |
|
Scientific Title of Study
|
Comparative Evaluation Of Peri-Implant Soft Tissue And Crestal Bone Loss Around Dental Implant With And Without T-PRF: A Clinico Radiographic CBCT 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 Aprajita Srivastava |
| Designation |
Post Graduate |
| Affiliation |
Subharti Dental College And Hospital Swami Vivekanand Subharti University Meerut |
| Address |
Room No 2 Department of Periodontology Subharti Dental College And Hospital Swami Vivekanand Subharti University Subhartipuram NH 58 Delhi-Haridwar Bypass Road Meerut
Uttar Pradesh
250005
India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9315978377 |
| Fax |
|
| Email |
dr.aprajitasrivastava07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayur Kaushik |
| Designation |
Professor And Head |
| Affiliation |
Subharti Dental College And Hospital Swami Vivekanand Subharti University Meerut |
| Address |
Room No 2 Department of Periodontology Subharti Dental College And Hospital Swami Vivekanand Subharti University Subhartipuram NH 58 Delhi-Haridwar Bypass Road Meerut
Uttar Pradesh
250005
India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9759444434 |
| Fax |
|
| Email |
drmayurkaushik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayur Kaushik |
| Designation |
Professor And Head |
| Affiliation |
Subharti Dental College And Hospital Swami Vivekanand Subharti University Meerut |
| Address |
Room No 2 Department of Periodontology Subharti Dental College And Hospital Swami Vivekanand Subharti University Subhartipuram NH 58 Delhi-Haridwar Bypass Road Meerut
Uttar Pradesh
250005
India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9759444434 |
| Fax |
|
| Email |
drmayurkaushik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 2 Department of Periodontology Subharti Dental College and Hospital Swami Vivekanand Subharti University NH58 Delhi Haridwar Bypass Road Meerut 250005 Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
Dr Aprajita Srivastava |
| Address |
Room Number 2 Department of Periodontology Subharti Dental College And Hospital Swami Vivekanand Subharti University
Haridwar Bypass road NH58
MEERUT
Uttar Pradesh
250005 |
| 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 Aprajita Srivastava |
Subharti Dental College And Hospital |
Room no. 2 Department of Periodontology Subharti Dental College And Hospital Swami Vivekanand Subharti University NH 58 Delhi
Haridwar Bypass Road
Meerut
UTTAR PRADESH
250005
India
Meerut
UTTAR PRADESH |
9315978377
dr.aprajitasrivastava07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients With Single Missing Tooth |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group 10 patients were selected Implant without T-PRF membrane |
A pre-operative immediate post-operative and 9 months RVG after implant placement
A preoperative and 9 months CBCT to assess the bone changes around implant |
| Intervention |
Test Group 10 patients were selected Implant with T-PRF Membrane |
A pre-operative immediate post-operative and 9 months RVG after implant placement
A preoperative and 9 months CBCT to assess the bone changes around implant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-50 years
2. Patients having single missing tooth with an adequate width and height
of edentulous space available for placement of implant
3. Edentulous sites in mandibular and maxillary arches.
4. Adjacent teeth intact; restored with functionally & esthetically good
restorations; restored with prosthesis precluding the addition of the missing tooth
5. Patients with good periodontal and general health |
|
| ExclusionCriteria |
| Details |
1. Patients who are unable to perform routine oral hygiene procedures
2. Patients with history of smoking
3. Patients with TMJ disorders
4. Patients with dental history of bruxism and parafunctional habits or deep bite cases
5. History of substance abuse
6. Insufficient vertical inter arch space to accommodate the prosthodontic components available, together with a proposed pontic and occasional gingival analog designs
7. Patients with uncontrolled diabetes
8. Absence of opposing occlusion |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Crestal Bone Loss Around Dental Implants
Evaluated Through Cone Beam Computed Tomography(CBCT) |
At Baseline And 9 Months After Implant Placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Peri-Implant Soft Tissue Health Around Dental
Implants Through Keratinized Mucosa INDEX AND PROBING DEPTH |
3 Months And 9 Months After Implant Placement |
|
|
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)
|
01/02/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
A total number of 20 patients with single missing tooth in mandibular and maxillary posterior region will be divided in two groups with 10 in each group randomly Test Group - Implant placement with T PRF membrane Control Group - Implant placement without T PRF membrane
Study Material The implant system used in this study will be i-Fix®
Following parameters would be recorded a. pre-operative and 9 months CBCT to assess the bone changes around the implant b. pre-operative,immediate post-operative and 9 months RVG after implant placement |