| CTRI Number |
CTRI/2024/03/063828 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of inflammation markers and bone loss in fluid around different dental implants over time |
|
Scientific Title of Study
|
Comparative evaluation of inflammatory biomarkers in peri implant crevicular fluid and crestal bone loss in two different implant collar designs at different time intervals:A clinical 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 |
DrPaulina |
| Designation |
Pg Student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Dept of Prosthodontics,
Manav Rachna Dental College
Faridabad,Haryana
Faridabad
HARYANA
121010
India |
| Phone |
8130586818 |
| Fax |
|
| Email |
rememberpaulina@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sapna Rani |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College, Faridabad |
| Address |
Department of Prosthodontics,
Manav Rachna Dental College
Faridabad
Faridabad
HARYANA
121010
India |
| Phone |
8375899663 |
| Fax |
|
| Email |
sapnarani.sds@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DrPaulina |
| Designation |
Pg Student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Dept of Prosthodontics,
Manav Rachna Dental College
Faridabad,Haryana
Faridabad
HARYANA
121010
India |
| Phone |
8130586818 |
| Fax |
|
| Email |
rememberpaulina@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College, Faridabad |
|
|
Primary Sponsor
|
| Name |
Dr.Paulina |
| Address |
Dept of Prosthodontics
Manav Rachna Dental College,Faridabad,Haryana |
| 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 Paulina |
Manav Rachna Dental College |
Department of Prosthodontics
Faridabad
HARYANA |
8130586818
rememberpaulina@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Dental College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Microthreaded collar implant placement |
After placement of implant ,inflammatory biomarkers in periimplant crevicular fluid and crestal bone levels will be assessed at different time intervals |
| Intervention |
Smooth collar design implant placement |
After placement of implant, inflammatory biomarkers in periimplant crevicular fluid and crestal bone levels will be assessed at different time intervals. The total duration of intervention will be 6 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with one missing tooth in the posterior mandibular molar area
Patients with good oral hygiene
Patients with adequate bone height and width to accommodate implant of appropriate dimension
Co-operative patient, willing to give consent
|
|
| ExclusionCriteria |
| Details |
Patients with a known history of any systemic diseases
Patients with a history of smoking
Patients with a history of intake of immunosuppressive drugs, anticoagulants, and anti-cancer drugs three months prior to the study
Patients with a history of radiotherapy
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effect of Micro-Thread Collar Design on crestal bone levels and inflammatory biomarkers
2. To evaluate the effect of Smooth Collar Design on crestal bone levels and inflammatory biomarkers
|
At the time of implant placement, 3 months and 6 months post-implant placement. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
Modification(s)
|
New developments in implant design and surface technology have emerged to minimize crestal bone level changes. Since implant collar or crest module is a trans-osteal portion of the implant that plays an important role in peri implant tissue’s health condition, so assessment of biomarker in Peri Implant Crevicular Fluid (PICF) is a valuable diagnostic tool to maintain peri-implant health around crest module. Although few studies are available but there is a lack of consensus regarding superior retention of crestal bone levels by roughened collars when compared to smooth (machined) collars in human studies. There is also paucity of literature on the correlation of loss of crestal bone levels with inflammatory markers with relation to different collar designs. This study, therefore aims to compare the affect of collar design on crestal bone levels and inflammatory bio markers. |