| CTRI Number |
CTRI/2020/12/029471 [Registered on: 01/12/2020] Trial Registered Prospectively |
| Last Modified On: |
28/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Ozonated Water as Irrigant on Peri-implant Tissue
|
|
Scientific Title of Study
|
Efficacy of Ozonated Water as Irrigant on Peri-implant Tissue:
A Clinico-radiographic Study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHUBHRANIL CHAKRABARTY |
| Designation |
PG STUDENT |
| Affiliation |
Saraswati Dental College |
| Address |
DEPARTMENT OF PERIODONTOLOGY,
SARASWATI DENTAL COLLEGE, 233 TIWARIGANJ, FAIZABAD ROAD, CHINHAT,LUCKNOW, 226028
Lucknow
UTTAR PRADESH
226028
India |
| Phone |
|
| Fax |
|
| Email |
riju.shubhranil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIVEK KUMAR BAINS |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Saraswati Dental College |
| Address |
DEPARTMENT OF PERIODONTOLOGY,
SARASWATI DENTAL COLLEGE, 233 TIWARIGANJ, FAIZABAD ROAD, CHINHAT,LUCKNOW, 226028
Lucknow
UTTAR PRADESH
226028
India |
| Phone |
|
| Fax |
|
| Email |
vivekbains@saraswaticolleges.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VIVEK KUMAR BAINS |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Saraswati Dental College |
| Address |
DEPARTMENT OF PERIODONTOLOGY,
SARASWATI DENTAL COLLEGE, 233 TIWARIGANJ, FAIZABAD ROAD, CHINHAT,LUCKNOW, 226028
Lucknow
UTTAR PRADESH
226028
India |
| Phone |
|
| Fax |
|
| Email |
vivekbains@saraswaticolleges.com |
|
|
Source of Monetary or Material Support
|
| SELF
Shubhranil Chakrabarty
MDS student
Department of Periodontology
Saraswati Dental College, Lucknow |
|
|
Primary Sponsor
|
| Name |
Saraswati dental college |
| Address |
Saraswati dental college, Faizabad road, Lucknow |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DRVIVEK KUMAR BAINS |
Saraswati Dental College |
DEPARTMENT OF PERIODONTOLOGY,
233 TIWARIGANJ, FAIZABAD ROAD
Lucknow
UTTAR PRADESH |
9935023439
vivekbains@saraswaticolleges.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Normal saline as irrigant during osteotomy procedure
|
| Comparator Agent |
Group B |
Ozonated water as irrigant during osteotomy preparation.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Systemically healthy patients (age 18 or more) with no contraindications for implant surgical procedure (ASA I).
2) Patients well motivated for surgery and maintaining good oral hygiene.
3) Patients are having missing teeth.
4) Patients having adequate residual bone will be included in this study
|
|
| ExclusionCriteria |
| Details |
1) Patient with clinically significant or unstable systemic disease effecting bone and soft tissue growth contraindicated implant procedure.
2) Patients on drugs that can effect bone turn over or immune inflammatory response in last 6 months.
3) Presence of chemo/ radiotherapy or a history of drug abuse.
4) Very close proximity of vital anatomic structures to the proposed implant site.
5) Patients required any regenerative procedure (as GBR), will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| peri-implant bone loss |
0, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
plaque index (PI), gingival index (GI) and peri-implant probing depth(PPD)
|
0,3 months |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
04/12/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The use of dental implants in the treatment of fully or
partially edentulous patients has become an important addition in oral/dental
rehabilitation. The success of implants has been attributed to osseointegration
or direct contact of the implant surface and bone without a fibrous connective
tissue interface. The high
level of predictability and success of current implant therapies have been the
result of the evolution of many techniques that promote osseointegration. Surgical placement of dental implants requires
an osteotomy. There is suspicion that osseous drilling may generate detrimental
heat in the site that may cause localized bone necrosis and subsequently
failure of the dental implant to osseointegrate. Cooling aqueous irrigation has
been advocated to prevent such overheating. During osteotomy procedure of
implant placement, ozone irrigation in the osteotomy sites, could enhance the
healing as well as promote osseointegration. Ozone reacts as an antioxidant,
able to promote homeostasis, enhance local oxygen supply and elicit
bactericidal effect.
|