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CTRI Number  CTRI/2024/09/073784 [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   THE EFFECTS OF OZONATED WATER USED AS IRRIGATION ON DENTAL IMPLANTS PLACED USING DIFFERENT DRILLING PROTOCOL. 
Scientific Title of Study   A COMPARATIVE EVALUATION OF THE EFFECTS OF OZONATED WATER AND NORMAL SALINE IRRIGATION ON DENTAL IMPLANTS PLACED USING OSSIODENSIFICATION 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 Vidhyapeeth Deemed to be University, Malkapur, 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 Vidhyapeeth Deemed to be University, Malkapur, Karad


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 Vidhyapeeth Deemed to be University, Malkapur, Karad


MAHARASHTRA
415110
India 
Phone  9900154295  
Fax    
Email  drkamnoorshubha@gmail.com  
 
Source of Monetary or Material Support  
Ozone water machine,ï‚§ Bredent sky Implants ï‚§ Standard implant surgical kit ï‚§ Conventional drill kit ï‚§ Densah bur kit ï‚§ PenguinResonance Frequency Analysis Unit ï‚§ Cone Beam Computed Tomography All are provided by School of Dental Sciences, Krishna Vishwa Vidhyapeet Deemed to be University, Karad, Malkapur, India 4151110 
 
Primary Sponsor  
Name  Krishna Vishwa Vidhyapeet 
Address  Krishna Vishwa Vidhyapeeth Deemed to be University, Malkapur,Karad 
Type of Sponsor  Other [Deemed University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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, SDS,KVV,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  
Status 
Not Applicable 
 
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  Normal Saline  Normal Saline used for irrigation during osteotomy and signs of inflammation observed after 2 days, 15 days and 2 months 
Intervention  Ozonated water  Ozonated water used for irrigation during osteotomy and signs of inflammation observed after 2 days, 15 days and 2 months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Two or more missing teeth in posterior maxilla

Adequate bone height, width and optimal bone density


Patient’s physical status, ASA Classes I and II
 
 
ExclusionCriteria 
Details  Undermined systemic disorders and immunosuppressed patients and patients with uncontrolled hypertension or diabetes.
Patients smoking more than 5 cigarettes/day and who have a history of alcoholism/drug abuse during last 5 years.
Patient with history of chemotherapy or radiation for the last 12 months.
Poor oral hygiene and severe or uncontrolled periodontitis  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the primary implant stability quotient (ISQ) values of dental implants placed with Osseodensification and conventional protocol using normal saline and ozonated water as an irrigant  2 days, 15 days and 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the primary implant stability (ISQ) values derived from Osseodensification protocol & conventional protocol using ozonated water & normal saline as irrigant  2 days ,15 days & 2 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, the sterilization protocol, which may come as a challenge to the implantologist. Implants placed in poor quality bone are often related to compromised stability and poor Osseointegration.

 

Osseodensification technique, could increase primary stability of dental implantsin poor quality bone. This procedure is characterized by low plastic deformation ofbone that is created by rolling and sliding contact using a densifying bur (Densahâ„¢ burs) that is fluted such that OD does not excavate bone but simultaneously compactsand autografts the particulate bone in an outward direction to create theosteotomy, thereby preserving vital bone tissue and densifying the bone at the site.

 

Ozone is known to react as an antioxidant, able to promote homeostasis, enhance local oxygen supply and elicit bactericidal effect particularly on staphylococcal and streptococcal infections. Previous literature has showed that ozone readily penetrates through the tissue, eliminates any bacterial, fungal and viral contamination.The application of ozone in oral surgery has an attempt to disinfect the oral cavity prior to surgery. Creating a sterile surgical environment in the oral cavity would be a desirable prerequisite for implant surgery. To get some way towards this goal, a sterile implant site is achieved by irrigating ozone water(25 μg/ml) during surgery. This would also promote healing and stimulate the immune system.

 

Resonance frequency analysis (RFA) is a non-invasive technique that gives a clinical measure of stability and presumed osseointegration of the placed implant.Assessment of inflammation through inflammatory biomarker C-Reactive Protien(CRP) with Interpretation of CRP levels will be done one day before (preoperative) the implant placement and after 48 h (postoperative) of implant placement in both the groups

The experimental design consists of

Group A – Implants placed using conventional implant technique

·          Sub group 1- irrigation done using normal saline

·         Sub group 2- irrigation done using ozonated water(25 μg/ml)

 

     Group B – Implants placed using osseodensification technique

·         Sub group 3- irrigation done using normal saline

·         Sub group 4- irrigation done using ozonated water(25 μg/ml)

All the groups will be subjected to Resonance Frequency Analysis(RFA) to determine the implant stability quotient (ISQ) during Implant placement.

 

The crestal bone loss of the groups will be radiographically determined at

1.      Implant placement

2.      After 6 months

3.      After 12 months

 
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