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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  
self 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
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