| CTRI Number |
CTRI/2022/11/047409 [Registered on: 18/11/2022] Trial Registered Prospectively |
| Last Modified On: |
30/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare and evaluate Ozone therapy and Photodynamic therapy as an adjunct to scaling and root planing in chronic periodontitis. |
|
Scientific Title of Study
|
Comparative Evaluation of Ozone therapy and photodynamic therapy as an adjunct to scaling and root planning in stage II and stage III chronic periodontitis: A split mouth randomized clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Humaira Siddique |
| Designation |
PG student |
| Affiliation |
VSPM Dental College and Research Centre |
| Address |
104,Department of Periodontics and Implant Dentistry,
VSPM Dental College and Research Centre
Digdoh Hills
Hingna Road
Nagpur 440019
Maharashtra
India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8983752866 |
| Fax |
|
| Email |
siddiquehumaira15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamalkishor Mankar |
| Designation |
Assistant Professor & Guide |
| Affiliation |
VSPM Dental College and Research Centre |
| Address |
104 Department of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills
Hingna Road
Nagpur 440019
Maharashtra
India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9850061038 |
| Fax |
|
| Email |
drkamalk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamalkishor Mankar |
| Designation |
Assistant Professor & Guide |
| Affiliation |
VSPM Dental College and Research Centre |
| Address |
104 Department of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills
Hingna Road
Nagpur 440019
Maharashtra
India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9850061038 |
| Fax |
|
| Email |
drkamalk@gmail.com |
|
|
Source of Monetary or Material Support
|
| 104,Department of Periodontics and Implant Dentistry,
VSPM Dental College and Research Centre
Digdoh Hills
Hingna Road
Nagpur 440019
Maharashtra
India
|
|
|
Primary Sponsor
|
| Name |
DR HUMAIRA SIDDIQUE |
| Address |
104,Department of periodontics and Implant Dentistry
VSPM DENTAL COLLEGE AND RESEARCH CENTRE
Digdoh Hills
Hingna Road
Nagpur 440019
Maharashtra
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 |
| humaira siddique |
VSPM DENTAL COLLEGE AND RESEARCH CENTRE |
104,Department of Periodontics and Implant Dentistry
VSPM DENTAL COLLEGE AND RESEARCH CENTRE,Digdoh Hills
Hingna Road
Nagpur 440019
Maharashtra
India
Nagpur
MAHARASHTRA |
08983752866
siddiquehumaira15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPM Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ozone therapy |
Maxillary arch will be divided into two sides in which ozone gel will be subgingivally placed on one side after scaling and root planing at baseline,2,4,6 months |
| Comparator Agent |
Photodynamic therapy |
Maxillary arch will be divided into two sides in which after scaling and root planing photodynamic therapy will be performed at baseline,2,4,6months |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Critera
1.Patients aged between 35-60yrs.
2.Patients with Stage II and Stage III Chronic Periodontitis.
3.Good general health
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1.Patients with systemic diseases or allergy to dyes.
2.Individual had a prior use of non steroidalanti inflammatory drugs or antimicrobial therapy in last 3 months.
3.Pregnant or lactating women.
4.Patient who has undergone periodontal treatment in last 6 months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical attachment level, periodontal pocket depth |
Baseline,2,4 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| gingival index |
Baseline,2,4and 6 months. |
|
|
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)
|
24/11/2022 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Procedure Clinical procedure Prior to initiating the study, its purpose and design will be explained and informed consent will be signed by every patient. Probing pocket depth and clinical attachment level will be measured using UNC-15 probe and custom made acrylic stent made to compare the measurement at each recall visit. Clinical procedure will include scaling and root planing and split mouth ozone therapy on one side and photodynamic therapy on other side. Patients will be instructed to refrain from chewing hard or sticky foods for 1 week. Patients will be recalled at 2 months,4 months and 6months postoperatively and gingival index and clinical parameters including clinical attachment level and periodontal pocket depth will be evaluated. |