| CTRI Number |
CTRI/2025/02/080479 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of peri-implant bone levels and tgf-alpha levels in peri-implant crevicular fluid in immediate vs delayed implant placement |
|
Scientific Title of Study
|
Comparative evaluation of immediate versus delayed loading on peri-implant bone levels and tgf-alpha levels in peri-implant crevicular fluid - A clinico-biochemical 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 |
SHREYA MISHRA |
| Designation |
POST GRADUATE |
| Affiliation |
ITS DENTAL COLLEGE |
| Address |
DEPARTMENT OF PERIDONTOLOGY, ROOM NO 5, ITS DENTAL COLLEGE, MURADNAGR, GHAZIABAD
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
8095059908 |
| Fax |
|
| Email |
shreyamishra_mds22_25@its.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
SHREYA MISHRA |
| Designation |
POST GRADUATE |
| Affiliation |
ITS DENTAL COLLEGE |
| Address |
Department of Periodontology, room no 5, ITS Dental College, Muradnagar, Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
8095059908 |
| Fax |
|
| Email |
shreyamishra_mds22_25@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
SHREYA MISHRA |
| Designation |
POST GRADUATE |
| Affiliation |
ITS DENTAL COLLEGE |
| Address |
Department of Periodontology, room no 5, ITS Dental College, Muradnaagr, Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
8095059908 |
| Fax |
|
| Email |
shreyamishra_mds22_25@its.edu.in |
|
|
Source of Monetary or Material Support
|
| ITS Dental College
Department of Periodontology, room no 5, ITS Dental College, Muradnagar, Ghaziabad |
|
|
Primary Sponsor
|
| Name |
SHREYA MISHRA |
| Address |
Department of Periodontology, room no 5, ITS Dental college, Muradnagar, Ghaziabad |
| Type of Sponsor |
Other [PRIVATE DENTAL COLLEGE] |
|
|
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 |
| SUMIT MALHOTRA |
ITS DENTAL COLLEGE, GHAZIABAD |
Department of Periodontology,room no 5 ITS Dental college, Muradnagar, Ghaziabad . Pin 201206
Ghaziabad
UTTAR PRADESH |
9582355523
sumitmalhotra@its.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of the ITS Centre for Dental Studies and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY HUMAN VOLUNTEER |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
delayed laoding |
delayed loading done after placement of implant followed by record keeping.
frequency : once
total duration : three months |
| Intervention |
immediete loading |
immediete loading done after placement of implant followed by record keeping.
frequency : once
total duration : three months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects aged above 18 years requiring Implant placement.
2. Patients with adequate oral hygiene status
3. No active periodontal disease
4. Sufficient bone quality (D1, D2 and D3) and quantity
5. Proper inter-occlusal space in missing tooth region
6. Patients who are willing to comply with the treatment protocol
7. Extraction must be done at least 3 months prior to treatment |
|
| ExclusionCriteria |
| Details |
1. Patients with uncontrolled diabetes.
2. Patients with autoimmune diseases, psychiatric disorders, osteoporosis
3. Patients undergoing or who underwent radiation therapy and chemotherapy to the head and neck region during the last 12 months
4. Patients with poor oral hygiene
5. Alcoholic, drug abusers and heavy smokers
6. Pregnant and lactating women
7. Sites with acute infection |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare levels of TGF –alpha in PICF around immediate and delayed loaded implants at 15 days, 1 month and at 3 months and to evaluate and compare the marginal bone loss at baseline to 3 months |
Baseline- 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparision of bleeding on probing and ISQ measurements between immediate and delayed loaded implants at baseline and 3 months. |
Baseline- 3 months |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
24/02/2025 |
| 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="0"
Months="3"
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
|
Introduction - According
to Albrektsson (1993), a successful implant should sustain less than 1.5 mm of
bone loss during the first year and less than 0.2mm annually thereafter. The
assessment of marginal bone loss around implants is carried out by means of
periapical radiographs and more recent advances like cbct. Another important
aspect is primary and secondary implant stability. Primary implant stability
directly dependents on bone quality. A promising tool for assessing
peri-implant bone formation is the detection of specific biomarkers in
peri-implant crevicular fluid. Tgf-alpha is an important biomarker during the
first stages of osseointegration, a fibrin-rich vascularized matrix populated
by fibroblast-like cells is created providing a template for future bone.
Aim - the
aim of this present study is to evaluate
and compare the peri-implant
bone loss between immediate and delayed loaded implants.
Materials
& methods - For group a, 8 sites indicated for replacement of missing tooth
with more than 6mm width and 10mm height of bone will be taken for implant
placement with immediate loading followed by placement of healing abutment.
Acrylic crown will be placed within 72hrs. For group b ,
8 sites indicated for replacement of missing tooth with sufficient height of
bone will be taken for implant placement with delayed loading followed by
placement of healing abutment. Picf samples will be collected at 15 days, 30
days and 90 days. Isq and crestal bone levels will be measured at baseline and
3 months.
|