| CTRI Number |
CTRI/2025/06/088639 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Implant placed in Non diabetic and controlled diabetic patient |
|
Scientific Title of Study
|
Correlation of crestal bone levels with expression of bone specific biomarkers around dental implants placed in Non Diabetic and Controlled Diabetic patients |
| 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 Soumya Parmar |
| Designation |
Post graduate student |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Periodontology Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9078239715 |
| Fax |
|
| Email |
soumyaparmar0297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Khatri |
| Designation |
Professor and HOD |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Periodontology Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9810720335 |
| Fax |
|
| Email |
drmanishkhatri@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Bansal |
| Designation |
Professor |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Periodontology Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9871655313 |
| Fax |
|
| Email |
drmansibansal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Dental Studies and Technologies Address: Room no 7,Department of Periodontology, NH-58, Delhi-Meerut Road,Kadrabad, Modinagar, Uttar Pradesh, India-201201 |
|
|
Primary Sponsor
|
| Name |
Institute of Dental Studies and Technologies |
| Address |
Room no 7, Department of Periodontology,NH-58,Delhi-Meerut Road,Kadrabad,Modinagar,Uttar Pradesh, India-201201 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrSoumya Parmar |
Institute of Dental studies and technologies |
Room no 7, Department of Periodontology, 2nd floor
Ghaziabad
UTTAR PRADESH |
9078239715
soumyaparmar0297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IDST Ethics Commitee |
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 |
| Intervention |
Implant in controlled diabetic patient. |
Implant placement in controlled diabetic patients, HbA1c value levels less than 6.9 |
| Comparator Agent |
Implant placement in systemically healthy patient |
Implant supported oral rehabilatation has increasingly improved the treatment options for edentulous patient reporting high long term survival and success rate |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Good oral hygiene
systemically healthy
Controlled diabetic
minimum two or even multiple number of missing teeth with sufficient bone length and width along with adequate inter-occlusal clearance. |
|
| ExclusionCriteria |
| Details |
Patients will be excluded if they are smokers or have para-functional habits, uncontrolled diabetes, blood disorders, immune-compromised state, and acute infection at site or aggressive periodontal disease. Patients on bisphosphonates, pregnant and lactating women will also be excluded from 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 |
mesial and distal crestal bone level
probing depth at four sites
alkaline phosphatase and c terminal collagen propetide serum evaluation increase or decrease in experimental & control group |
crestal bone level at baseline, 3 month,6 month
alkaline phosphatase and c terminal collagen propeptide evaluation at baseline, 3 month and 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Modified plaque index (mPI).
Simplified gingival index (sGI).
Modified sulcular bleeding index (mSBI)
|
Baseline(at the time of crown placement), 3 months
probing depths at four sites (mesiobuccal, mid-buccal, distobuccal and mid-palatal/lingual)
|
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/06/2025 |
| 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="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
This study will be conducted and compiled by Dr. Soumya Parmar, Dr Manish Khatri, Dr. Mansi Bansal, Dr. Sakshi Gaind at Department of Periodontology, Institute of Dental Studies and Technologies, modinagar,Uttar pradesh,India.The purpose of the study to evaluate the crestal bone level with expression of bone specific serum biomarkers [alkaline phosphatase (ALP) and C- terminal collagen propeptide (CICP)] around dental implants placed in non-diabetic and controlled diabetic patients. |