| CTRI Number |
CTRI/2025/05/086087 [Registered on: 01/05/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of ozone gel placed in gums of patients with gum disease. |
|
Scientific Title of Study
|
Evaluation and Comparison of Ozone Gel as an adjunct to Scaling and Root planing versus Scaling and Root planing alone for Non-surgical treatment of Chronic Periodontitis: A
Randomized Controlled Trial. |
| 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 Ankit Desai |
| Designation |
Reader |
| Affiliation |
Terna dental college and Hospital |
| Address |
Department 101, Plot no.12, Terna Campus Rd, opp. nerul west
Railway station, Sector 22,Nerul,Navi Mumbai Mumbai
MAHARASHTRA 400706 India
Thane
MAHARASHTRA
India
Thane
MAHARASHTRA
400706
India |
| Phone |
9920789319 |
| Fax |
|
| Email |
desaiankit_2000@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanika Patil |
| Designation |
Post graduate student |
| Affiliation |
Terna dental college and Hospital |
| Address |
Department 101, Plot no.12, Terna Campus Rd, opp. nerul west
Railway station, Sector 22,Nerul,Navi Mumbai Mumbai
MAHARASHTRA 400706 India
Thane
MAHARASHTRA
India
Thane
MAHARASHTRA
400706
India |
| Phone |
7420830981 |
| Fax |
|
| Email |
drsanika99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanika Patil |
| Designation |
Post graduate student |
| Affiliation |
Terna dental college and Hospital |
| Address |
Department 101, Plot no.12, Terna Campus Rd, opp. nerul west
Railway station, Sector 22,Nerul,Navi Mumbai Mumbai
MAHARASHTRA 400706 India
Thane
MAHARASHTRA
India
MAHARASHTRA
400706
India |
| Phone |
7420830981 |
| Fax |
|
| Email |
drsanika99@gmail.com |
|
|
Source of Monetary or Material Support
|
| 101, First floor, Department of Periodontology, Terna Dental College Plot No. 12, Sector- 22, Nerul (W), Navi Mumbai. Maharashtra (India) Pin – 400706 |
|
|
Primary Sponsor
|
| Name |
TPCTs Terna Dental College |
| Address |
Plot no. 12, Campus Rd,Opp. Nerul west Railway station , Sector 22,
Nerul west, Sector 22, Nerul, Navi Mumbai Mumbai
MAHARASHTRA 400706 India |
| Type of Sponsor |
Other [Private Dental College] |
|
|
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 Sanika Patil |
Terna Dental College |
Department 101, Plot no.12, Terna Campus Rd, opp. nerul west
Railway station, Sector 22,Nerul,Navi Mumbai Mumbai
MAHARASHTRA 400706 India
Thane
MAHARASHTRA
India
Thane
MAHARASHTRA |
7420830981
drsanika99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Terna Dental College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic periodontitis |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ozonated olive oil with scaling and root planing |
Patients exhibiting clinical signs of chronic periodontitis bilaterally requiring non-surgical treatment will be
treated with scaling and root
planing followed by subgingival delivery of ozone. Baseline evaluation will
be done for plaque index,
gingival index, modified sulcular bleeding index, probing pocket depth, clinical attachment loss. Patient
will be recalled after 1 month
and 3 months for the evaluation
of same. |
| Comparator Agent |
Scaling and root planing |
Patients exhibiting clinical signs of chronic periodontitis bilaterally requiring non-surgical treatment will be
treated with scaling and root
planing alone. Baseline evaluation will
be done for plaque index,
gingival index, modified sulcular bleeding index, probing pocket depth, clinical attachment loss. Patient
will be recalled after 1 month
and 3 months for the evaluation of same. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Adult patients
2)Bilateral periodontal sites, presence of at least one site in each quadrant with a probing depth of 5-7mm
3)Absence of systemic disease.
|
|
| ExclusionCriteria |
| Details |
1) Absence of dental implants
2) Use of bisphosphonates 12 months prior to entry in the study
3) Pregnant/ lactating women
4) Anti-cancer therapy |
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Ozone Gel as an adjunct to scaling and root planing versus scaling and root planing alone for Non-surgical treatment of Chronic Periodontitis.
|
At baseline
After 1 month
After 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
15/06/2025 |
| 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="0"
Months="3"
Days="0" |
|
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
|
This is a randomized clinical split mouth study to evaluate
the clinical efficacy of sub-gingivally delivered ozone as an adjunct to scaling
and root plaing in patients undergoing non-surgical treatment of chronic
periodontitis. It is a split-mouth study.
Study design :
Group 1 consisting of 15 sites with 4-7mm pockets, receiving
ozone as a local drug delivery agent along with scaling and root planning.
Group 2 consisting of 15 sites with 4-7mm pockets, receiving
undergoing scaling and root planning alone.
The clinical parameters [ plaque index, gingival index,
relative attachment loss, probing pocket depth , modified sulcular bleeding
index]will be evaluated at baseline, one month and three month period. |