| CTRI Number |
CTRI/2020/01/023070 [Registered on: 31/01/2020] Trial Registered Prospectively |
| Last Modified On: |
17/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
OXYGEN THERAPY IN PERIODONTITIS |
|
Scientific Title of Study
|
EVALUATION OF OXYGEN THERAPY IN PERIODONTITIS SUBJECTS : A CLINICAL AND HISTOLOGICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MAMIDI NAGA VENKATA SAI ANUSHA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
KAMINENI INSTITUTE OF DENTAL SCIENCES |
| Address |
Kamineni Institute of Dental Sciences, Sreepuram,Narketpally, Nalgonda. Kamineni Institute of Dental Sciences,Sreepuram, Narketpally,
Nalgonda. Nalgonda TELANGANA 508254 India |
| Phone |
8143635336 |
| Fax |
08682272296 |
| Email |
mnv.saianusha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr G JAGADISH REDDY |
| Designation |
PROFESSOR |
| Affiliation |
KAMINENI INSTITUTE OF DENTAL SCIENCES |
| Address |
Kamineni Institute of Dental Sciences,
Sreepuram, Narketpally,Nalgonda
Kamineni Institute of Dental Sciences,
Sreepuram, Narketpally,Nalgonda Nalgonda TELANGANA 508254 India |
| Phone |
9949801470 |
| Fax |
|
| Email |
drjagadishreddy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr G JAGADISH REDDY |
| Designation |
PROFESSOR |
| Affiliation |
KAMINENI INSTITUTE OF DENTAL SCIENCES |
| Address |
Kamineni Institute of Dental Sciences,
Sreepuram, Narketpally,Nalgonda
Kamineni Institute of Dental Sciences,
Sreepuram, Narketpally,Nalgonda
Nalgonda TELANGANA 508254 India |
| Phone |
9949801470 |
| Fax |
08682272296 |
| Email |
drjagadishreddy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
self |
| Address |
Kamineni Institute of Dental Sciences,
Sreepuram, Narketpally-508 254,
Nalgonda (Dist) T.S.
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| MAMIDI NAGA VENKATA SAI ANUSHA |
DEPARTMENT OF PERIODONTICS |
Kamineni Institute of Dental Sciences,Sreepuram,Narketpally Nalgonda TELANGANA |
8143635336
mnv.saianusha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE,KIDS,NARKETPALLY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
oxygen therapy |
After oxygen therapy in periodontal pockets, collagen turnover and Pocket depth reduction is observed |
| Comparator Agent |
single arm trial |
No comparator is applicable for the study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects should have Interdental clinical attachment loss detectable at >2mm or,
2.Probing pocket depth >5mm is detectable at > 2teeth.
|
|
| ExclusionCriteria |
| Details |
1.Subjects suffering from diabetes & asthma.
2.Usage of tobacco in any form.
3.Subjects who underwent periodontal treatment within last 6 months.
4.Subjects who are allergic to ingredients of Blue m gel.
5.Pregnancy and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| COLLAGEN TURNOVER |
Baseline,4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Gingival index [Loe and Sillness,1963]
2.Probing pocket depth
3.Clinical attachment level
4.Wound healing index [Landry et al]
5.Pain visual analogue scale
|
BASELINE, 1 WEEK, 4 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
03/02/2020 |
| 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="6" Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
To publish in a peer reviewed journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
| Oxidative stress lays at the heart of periodontal tissue damage, resulting from host-microbial interactions either as a direct result of excess reactive oxygen species (ROS) activity or indirectly as a result of activation of redox-sensitive transcription factors and creation of pro-inflammatory state. Free radicals and ROS are essential to many biologic processes. At low concentrations, these free radicals stimulate the growth of fibroblasts and epithelial cells in culture, but at higher concentrations it may result in tissue injury. The antioxidant system developed by human body functions to detoxify ROS and modify them to form less reactive species. ROS includes hydrogen peroxide, hypochlorous acid, singlet oxygen and ozone. In general, treatment of periodontitis is multifaceted and vigorous, including mechanical, antibiotic and antiseptic therapy, and the various treatment approaches should be employed within a short time period. Now a day various novel therapeutic approaches are tried as an alternative to conventional therapy or in combination with conventional therapy to reduce load periodontopathic pathogens. The ultimate goal of periodontal therapy is to regenerate the lost periodontal tissue. One of the effective therapeutic measures can be topical oral oxygen therapy (TOOTh).It is a low pressure oxygen therapy which applies oxygen directly to the wound site. Wound healing requires a variety of cells to increase their metabolic activity, resulting in a high oxygen demand. Oxygen at the wound site has been shown to promote wound healing by stimulating several processes, including neovascularization, collagen production. Collagen forms the structural network of the connective tissue component of oral mucosa and is present in fibrillar form.It strengthens the blood vessels and play a role in tissue development. It also plays a key role in regulating periodontal tissues during the development and regeneration. Collagen can be viewed by staining the tissue with the special stain known as masson trichrome stain which is tricoloured stain and stains collagen in blue colour. One of the example of TOOTh is the application of blue® m gel which uses a mechanism of delivering oxygen in controlled manner directly to trauma site and is safe,effective and non-invasive therapy. The application of this gel releases oxygen molecules that can penetrate much deeper into the biofilm to kill the anaerobic bacteria even in the perimucosal seal around the implant.It even acts as a bone growth accelerator by the presence of lactoferrin which potentially stimulates the proliferation and differentiation of primary osteoblasts.The application of the gel is very simple as it is placed directly deep into the pocket with a disposable syringe. It has wide variety of uses in gingivitis, periodontitis, peri implantitis, acute wound healing after tooth extraction etc. | Hence the present study will be evaluating the efficacy of oxygen therapy in chronic periodontitis patients. |