| CTRI Number |
CTRI/2024/09/073785 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of different loading protocol on dental implants placed using osseodensification and conventional drilling protocol. |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF THE EFFECTS OF PROGRESSIVE AND CONVENTIONAL LOADING PROTOCOL ON DENTAL IMPLANTS PLACED USING OSSEODENSIFICATION AND CONVENTIONAL DRILLING PROTOCOL- AN IN-VIVO 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 Shubha Joshi |
| Designation |
Associate Professor |
| Affiliation |
Krishna Vishwa Vidhyapeet Deemed to be University |
| Address |
Department of Prosthodontics, School of Dental Sciences, Krishna Vishwa Vidhyapeet Deemed to be University,Karad
Satara
MAHARASHTRA
415110
India |
| Phone |
9900154295 |
| Fax |
|
| Email |
drkamnoorshubha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubha Joshi |
| Designation |
Associate Professor |
| Affiliation |
Krishna Vishwa Vidhyapeet Deemed to be University |
| Address |
Department of Prosthodontics, School of Dental Sciences, Krishna Vishwa Vidhyapeet Deemed to be University,Karad
Satara
MAHARASHTRA
415110
India |
| Phone |
9900154295 |
| Fax |
|
| Email |
drkamnoorshubha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubha Joshi |
| Designation |
Associate Professor |
| Affiliation |
Krishna Vishwa Vidhyapeet Deemed to be University |
| Address |
Department of Prosthodontics, School of Dental Sciences, Krishna Vishwa Vidhyapeet Deemed to be University,Karad
Satara
MAHARASHTRA
415110
India |
| Phone |
9900154295 |
| Fax |
|
| Email |
drkamnoorshubha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Implant surgical kit, Dental Implants, CBCT, RFA, Denshah Bur kit, PFM Crowns will be provided in School of Dental Sciences, Krishna Vishwa Vidhyapeet Deemed to be University, Karad. |
|
|
Primary Sponsor
|
| Name |
Krishna Vishwa Vidhyapeet |
| Address |
Krishna Vishwa Vidhyapeet Deemed to be University, Malkapur, Karad, India 415110 |
| Type of Sponsor |
Other [Deemed University] |
|
|
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 Shubha Joshi |
School of Dental Sciences |
Department of Prosthodontics, Room No:12, Krishna Vishwa Vidhyapeeth Deemed to be University, Malkapur, Karad
Satara
MAHARASHTRA |
9900154295
drkamnoorshubha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Krishna Vishwa Vidhyapeet (Deemed to be University) Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional loading |
Final crowns are cemented after 3 months |
| Intervention |
progressive loading |
Temporary crowns on the implants placed will be loaded progressively using step up temporaries |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Two or more missing teeth ,
adequate bone height, width and optimal bone density,
patients physical status,ASA Classes I & II |
|
| ExclusionCriteria |
| Details |
Undermined systemic disorders and immunosuppersed patients and patients with uncontrollled hypertension and diabetis.
patients smoking more than 5 cigarettes per day and who have history of alcoholism/drug abuse during last 5 years
patients with history of chemotherapy or radiation for last 12 months
poor oral hygiene and severe uncontrolled periodontitis |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary stability at implant placement, after 6 months and after 12 months |
Primary stability at implant placement, after 6 months and after 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine & compare the primary implant stability quotient (ISQ) values of dental implants placed with Osseodensification & conventional protocol
To determine & compare the secondary implant stability quotient (ISQ) values of implants loaded using the progressive loading & conventional loading protocol
To radiographically determine the crestal bone loss in cases with progressive & conventional loading of implants.
To compare the crestal bone loss of dental implants that undergo progressive & conventional loading protocols
|
0, 6 & 12 months |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
05/10/2024 |
| 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="6"
Days="7" |
|
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
|
Dental implants, in today’s world are considered one of the best alternatives for replacement of missing teeth, showing better results in esthetics and function. The success rate of dental implants depends largely on the quality of bone present, and the ridge, which may come as a challenge to the implantologist. Implants placed in poor quality bone are often related to compromised stability and poor Osseo- integration. The Osseodensification technique, could increase primary stability of dental implant in poor quality bone. This procedure is characterized by low plastic deformation of bone that is created by rolling and sliding contact using a densifying bur (Densah™ burs) that is fluted such that OD does not excavate bone but simultaneously compact and autografts the particulate bone in an outward direction to create the osteotomy, thereby preserving vital bone tissue and densifying the bone at the site. Bone is known to form under mechanical stresses. Implants loaded using the progressive loading technique, in which a temporary prosthesis is placed within 48 hours at infra-occlusion and is then adjusted at regular intervals to increase the height of the prosthesis until it is eventually brought into occlusion, has in this regard shown less peri implant bone loss and better implant success rate. Resonance frequency analysis (RFA) is a non-invasive technique that gives a clinical measure of stability and presumed osseo-integraion of the placed implant. The experimental design consists of Group A – Implants placed using Osseodensification technique · Sub group 1- Implants loaded using progressive loading protocol · Sub group 2- Implants loaded using conventional loading protocol Group B – Implants placed using conventional implant placement technique · Sub group 3- Implants loaded using progressive loading protocol · Sub group 4- Implants loaded using conventional loading protocol All the groups will be subjected to Resonance Frequency Analysis(RFA) to determine the implant stability quotient (ISQ)at 1. Implant placement 2. After 6 months 3. After 12 months The crestal bone loss of the groups will be radiographically determined at 1. Implant placement 2. After 6 months 3. After 12 months |