| CTRI Number |
CTRI/2025/04/084932 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on effect of how Ozonated Olive Oil Affects Wound Healing and Bone Growth Around Dental Implants" |
|
Scientific Title of Study
|
Evaluation of the Effect of Ozonated olive oil on Soft tissue and Hard tissue changes around Non submerged Dental Implant |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandra Haritha |
| Designation |
MDS |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
ANDHRA PRADESH 522509
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
7989752309 |
| Fax |
|
| Email |
harithasandra951@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Ravindranath |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
ANDHRA PRADESH 522509
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9849222259 |
| Fax |
|
| Email |
ravident69@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandra Haritha |
| Designation |
MDS |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
ANDHRA PRADESH 522509
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
7989752309 |
| Fax |
|
| Email |
harithasandra951@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no-8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509,India |
|
|
Primary Sponsor
|
| Name |
Sandra Haritha |
| Address |
Room no-8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509,India |
| Type of Sponsor |
Other [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 |
| Sandra Haritha |
Sibar Institute of Dental Sciences |
Room no-8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509 Guntur
ANDHRA PRADESH
Guntur
ANDHRA PRADESH |
7989752309
harithasandra951@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sibar Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, (2) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ozonated olive oil |
Implants will be placed with Ozonated olive oil coating and patients will be followed up at 1st week,2nd week,3months and 6months |
| Comparator Agent |
Without Ozonated olive oil |
Implants will be placed without Ozonated olive oil coating and patients will be followed at 1st week,2nd week,3months and 6monts |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals with an age group of 20-60 years of either gender
2.Presence of adequate horizontal(4-5mm) and vertical (12mm) dimensions of the alveolar bone based on CBCT.
3.Presence of adequate keratinized mucosa (minimum 1 mm) in the edentulous site.
4.Apparently healthy individuals.
5.Individuals with bone density classified as D2 and D3 type of bone.
|
|
| ExclusionCriteria |
| Details |
1. Any forms of tobacco users.
2. Pregnant and lactating women.
3. Subjects taking any medication which effect healing and bone metabolism.
4. Individuals with parafunctional habits.
5. History of radiotherapy to head and neck.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the wound healing around implants coated with ozonated olive oil. |
1st week &2nd week after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the crestal bone level around implants coated with ozonated olive oil. |
Baseline ,3 months and 6 months |
| To evaluate Implant stability around implants coated with Ozonated olive oil |
Baseline and 3months. |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
01/06/2025 |
| 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="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study is an randomiz ed clinical trial comparing the effects of Ozonated olive oil on hard tissue and soft tissue changes around non submerged dental implants After patient selection based on eligibility criteria ,Phase1 therphy oral prophylaxis and surgical stunt fabrication will be done and patient will be recalled after 1week.The procedure will be performed under local anesthesia using 2%lignocaine containing adrenaline in 1:80,000 ratio .A mid crestal incision will be given and osteotomy site will be prepared. In Group1 implants without Ozonated olive oil will be placed .In Group 2 Implants coated with Ozonated olive oil will be placed.After placement stability will be checked with resonance frequency analysis at baseline .Healing abutment will be placed and flaps will be approximated and sutured. Patient will be recalled after 1st week,2nd week for evaluating wound healing 3months and 6months for crestal bone level and 3months for implant stability. |