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CTRI Number  CTRI/2025/04/084903 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 14/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Evaluation Of The Effect Of Antioxidant Therapy On Oxidative Stress Produced In Patients Undergoing Fixed Appliance Therapy-A Randomized Controlled Trial  
Scientific Title of Study   Comparative Evaluation Of The Effect Of Antioxidant Therapy On Oxidative Stress Produced In Patients Undergoing Fixed Appliance Therapy-A Randomized Control 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 Mayuri Suhas Desai  
Designation  Postgraduate  
Affiliation  Manipal College of Dental Sciences, Mangalore 
Address  1st floor,Department Of Orthodontics and Dentofacial Orthopaedics, Manipal College of Dental Sciences, Mangalore. Affiliated to Manipal Academy of Higher Education, Manipal.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9881109923  
Fax    
Email  desaimay@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Asavari Desai 
Designation  Associate Professor 
Affiliation  Manipal College of Dental Sciences, Mangalore 
Address  1st floor, Department of Orthodontics and dentofacial orthopaedics, Manipal College of Dental Sciences, Mangalore. Affiliated to Manipal Academy of Higher Education, Manipal.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9483363045  
Fax    
Email  desaiasavari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Asavari Desai 
Designation  Associate Professor 
Affiliation  Manipal College of Dental Sciences, Mangalore 
Address  1st floor, Department of Orthodontics and dentofacial orthopaedics, Manipal College of Dental Sciences, Mangalore. Affiliated to Manipal Academy of Higher Education, Manipal.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9483363045  
Fax    
Email  desaiasavari@gmail.com  
 
Source of Monetary or Material Support  
Manipal College of Dental Sciences, Mangalore 
 
Primary Sponsor  
Name  Dr Mayuri Suhas Desai  
Address  1st floor, Department of Orthodontics and Dentofacial Orthopaedics, Mangalore. Affiliated to Manipal Academy of Higher Education, Manipal 
Type of Sponsor  Other [Self] 
 
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 
Dr Mayuri Suhas Desai  Manipal College Of Dental Sciences, Mangalore  1st floor, Department of Orthodontics and dentofacial orthopaedics, Manipal College of Dental Sciences, Mangalore. Affiliated to Manipal Academy of Higher Education, Manipal.
Dakshina Kannada
KARNATAKA 
9881109923

desaimay@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  systemically healthy patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  patients undergoing fixed orthodontic therapy only.  control group receiving only fixed orthodontic treatment without the antioxidant supplementation. 
Intervention  Patients undergoing fixed orthodontic treatment and taking antioxidant supplements   patients receiving fixed orthodontic treatment with Antoxid HC capsule orally once daily for 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  - Patients with good general and oral health
- Patients with no prior orthodontic treatment in last 24 months
 
 
ExclusionCriteria 
Details  - Smokers or tobacco users
- Patients with active periodontal disease at the time of enrollment
- Patients with systemic diseases such as diabetes, autoimmune diseases, or chronic inflammatory conditions.
- Patients taking antioxidant supplements, multivitamins, or medications that could affect oxidative stress levels within the past 6 weeks.
- Patients undergoing concurrent dental treatments that may influence salivary biomarkers (e.g., periodontal therapy, restorative treatments).
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the impact of antioxidant supplements on oxidative stress levels in patients undergoing fixed orthodontic therapy, using salivary biomarkers  T1: Before starting the fixed orthodontic therapy.
T2: One-month follow-up.
T3: Three-month follow-up.
 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the temporal changes in oxidative stress levels (at baseline, 1 month, and 3 months) in patients undergoing fixed orthodontic therapy  T1: Before starting the fixed orthodontic therapy.
T2: One-month follow-up.
T3: Three-month follow-up.
 
1. To assess the oxidative stress generated in patients undergoing fixed orthodontic treatment.  T1: Before starting the fixed orthodontic therapy.
T2: One-month follow-up.
T3: Three-month follow-up.
 
3. To compare the levels of oxidative stress in patients receiving fixed orthodontic therapy with and without antioxidant supplementation.  T1: Before starting the fixed orthodontic therapy.
T2: One-month follow-up.
T3: Three-month follow-up.
 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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 1 
Date of First Enrollment (India)   02/06/2025 
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="0"
Days="0" 
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  

Orthodontic treatment uses fixed appliances to promote oral health and correct malocclusions. Several inflammatory mediators are released in response to the mechanical forces applied during treatment. The ensuing inflammation in the oral cavity leads to oxidative stress, which is defined as the imbalance between the production of free radicals and the body’s ability to arrest or minimize their harmful effects through neutralization by anti-oxidants. It is a pathologic asymptomatic event, highly detrimental to tissues, and in recent years, has been considered as a trigger event for several human diseases.

Oxidative damage is caused mainly by the release of free radicals generated by exposure to UV rays, X rays and can also be produced by leukocytes and macrophages during the inflammatory process. From a biological and pathological point of view, the most important free radicals are the reactive oxidative species(ROS) and the important ones to be considered are the superoxide anion (O2), hydrogen peroxide(H2O2), hydroxyl radical(OH), and hypochloric acid(HOCl).

Phospholipid membranes are primarily the biological targets of oxidative stress. The most abundant cellular component, proteins, are also significant targets for free radicals; even minor changes to one protein can have a significant impact on the biological activity and functionality of cells.

Oxidative stress (O.S.) has been implicated to be the causative factor of numerous pathological illnesses, such as rheumatoid arthritis, neurological diseases, atherosclerosis, inflammatory diseases, chronic renal failure, and even diabetes. Intraorally, it is involved in the development of enamel surface alteration, caries, squamous cell carcinoma and periodontitis. Osteoblastic and osteoclastic cells involved in the bone remodeling process are also particularly sensitive to oxidative damage. 

Saliva is a vital component of the oral cavity and can be considered as the first barrier to oxidative stress due to its antioxidant capacity. It helps to maintain oral health, contributes to the body’s oral defense, and the balance of the oral environment. Saliva has gained popularity as a diagnostic tool in clinical studies in recent years, due to its accessibility, ease of collection, and the possibility of taking repeated, non-invasive samples for screening, diagnosing, and researching a variety of illnesses. Therefore, oxidative status assessment in the oral cavity has been proposed as a key diagnostic and progression assessment method for these disorders.

Over the past few years, several studies have provided evidence of O.S. associated with orthodontic treatment which may have significant clinical implications with serious consequences for long-term oral health. Antioxidant supplements have been proposed to be effective in containing the oxidative stress produced however there is no published literature available on the same. This trial was therefore taken up to assess and compare the effect of antioxidant supplementation on the oxidative stress produced by fixed orthodontic treatment.

 
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