| 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
|
|
|
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
|
|
|
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 |