| 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
|
|
|
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
|
|
|
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. |