| CTRI Number |
CTRI/2026/01/100391 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Revolutionizing Implant Loading: Prospective Clinical Trial in Partially Edentulous Patients. |
|
Scientific Title of Study
|
Pioneering Immediate loading in tissue and bone level implants- A prospective clinical trial across diverse patient profiles in partially edentulous ridges. |
| 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 Anshul Trivedi |
| Designation |
Associate professor |
| Affiliation |
Subharti Dental College and Hospital, Swami vivekanand University , Meerut |
| Address |
Room no - 6
Department of Prosthodontics & Crown and Bridge, Subharti Dental College and hospital, Subhartipuram, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9012694104 |
| Fax |
|
| Email |
dranshulmsaxena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anshul Trivedi |
| Designation |
Associate professor |
| Affiliation |
subharti dental college and hospital, swami vivekanand university, Meerut |
| Address |
Room no - 6
Department of Prosthodontics & Crown and Bridge, Subharti Dental College and hospital, Swami Vivelanand University,Subhartipuram, Meerut.
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9012694104 |
| Fax |
|
| Email |
dranshulmsaxena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anshul Trivedi |
| Designation |
Associate professor |
| Affiliation |
subharti dental college and hospital, meerut |
| Address |
Room no - 6
Department of Prosthodontics & Crown and Bridge, Subharti Dental College and hospital, Subhartipuram, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9012694104 |
| Fax |
|
| Email |
dranshulmsaxena@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sweta |
| Address |
Swami Vivekanand Subharti University, Subharti Dental College and Hospital, Meerut. |
| Type of Sponsor |
Other [for my research study(thesis) , I am the primary sponsor here(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 Sweta |
Subharti Dental College and Hospital,Meerut |
Department of Prosthodontics & crown and bridge, Room number 6, PG section, Swami Vivekanand Subharti University,Subharti Dental College and Hospital, Subhartipuram, Meerut
Meerut
UTTAR PRADESH |
07249915010
teotiasweta2900@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee(Medical) Swami Vivekanand Subharti University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E07||Disorders of thyroid gland, (2) ICD-10 Condition: I10||Essential (primary) hypertension, (3) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Immediate loading in bone level and tissue level implant |
Bone and Tissue level implants will be placed in partially edentulous ridges particularly in medically compromised patients followed by immediate loading. After an optimum osseointegration period of 3-4 months, definitive prosthesis will be delivered.
Follow up readings will be taken up - Baseline readings, at the end of 3rd month interval, 6th month interval and one year interval. |
| Comparator Agent |
Tissue level and Bone level implants |
Tissue level and bone level implants will be placed in partially edentulous ridges particularly in medically compromised patients followed by immediate loading. After an optimum osseointegration periodof 3-4 months, definitive prosthesis will be delivered.
Follow up readings will be taken up - Baseline readings, at the end of 3rd month interval, 6th month interval and one year interval. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
1)Age : 18-75 years
2)Patient willing for procedure (the study is explained, including the procedure and followup for evaluation)
3)Partially edentulous patients indicated replacement with an implant.
4)Patient presents with controlled diabetes/hypertension
5)Implant site free from infection
6)Adequate mouth opening
7) Sufficient bone volume for placing implants
8)Implants should be placed at healed sites. |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
1.Insufficient bone quality
2. Inadequate mouth opening
3. Heavy smokers
4. Chronic alcoholic
5. Presence of vital anatomical structures close to the implant site
6. Patient under immunosuppressive therapy or radiotherapy
7. Psychiatric disorders
8. Disorders to the implant site related to a history
of radiation therapy to the head and neck, or bone augmentation.
9.Recent myocardial infarction or cerebrovascular accident, ongoing chemotherapy treatment, intravenous anti-angiogenic agents use
10.Untreated bleeding issues
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of radiological, biological, and prosthetic outcomes of immediate loading in tissue and bone level implants.
1. Width of keratinised gingiva
2. IOPA with grid and cbct to measure crestal bone loss
3. incidence, frequency, onset of screw loosening |
1. width of keratinised gingiva will be assessed at 3rd month interval, 6th month interval and at the end of one year interval.
2.IOPA with Grid to measure crestal bone loss will be assessed at 3rd month ,6th month , and at the end of one year interval.
3.Incidence/ Frequency /onset of screw loosening at 3, 6 and 1 year interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Crestal Bone Loss: Assessing the amount of crestal bone loss around the implants at various follow-up intervals.
2.Width of Keratinized Mucosa: Measuring the width of keratinized mucosa at the implant site, specifically at the mid-buccal aspect of each implant.
3.Incidence, Frequency & onset of screw loosening
|
1.3rd month interval, 6th month interval & at the end of one year interval.
2. at 3rd month ,6th month , & at the end of one year interval.
3.At 3rd,6th, & one year interval. |
|
|
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)
|
22/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
This prospective clinical trial aims to evaluate the clinical efficacy and outcomes of immediate loading in tissue and bone level implants among patients with partially edentulous ridges at Subharti Dental College and Hospital in Meerut. By assessing radiological, biological, and prosthetic parameters, the study seeks to understand implant performance in patients with systemic conditions such as diabetes and hypertension. With a sample size of 20 implants, equally divided between tissue and bone level types, the research hypothesizes that tissue level implants will show better soft tissue integration and lower crestal bone loss compared to bone level implants. The results aim to enhance clinical decision-making and improve patient care in medically compromised populations over a two-year period. |