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CTRI Number  CTRI/2025/12/098443 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 03/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative evaluation of effect of Antioxidant therapy on the implant stability and crestal bone loss in smokers and non-smokers 
Scientific Title of Study   Effect of two different Antioxidant therapies on the implant stability and crestal bone loss in smokers and non-smokers: A Randomized Controlled 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  Rajlakshmi Sujoy Banerjee 
Designation  Associate Professor 
Affiliation  RDDC and Research centre (VSPM DCRC) 
Address  Dept of Prosthodontics, 2nd floor, room no 201, Hingna Road, Nagpur 440019

Nagpur
MAHARASHTRA
440019
India 
Phone  09890324934  
Fax    
Email  drrajlakshmi1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rajlakshmi Sujoy Banerjee 
Designation  Associate Professor 
Affiliation  RDDC and Research centre (VSPM DCRC) 
Address  Dept of Prosthodontics, Room no 201, Hingna Road, Nagpur 440019

Nagpur
MAHARASHTRA
440019
India 
Phone  09890324934  
Fax    
Email  drrajlakshmi1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rajlakshmi Sujoy Banerjee 
Designation  Associate Professor 
Affiliation  RDDC and Research centre (VSPM DCRC) 
Address  Dept of Prosthodontics, Room No 201, 2nd floor, Hingna Road, Nagpur 440019

Nagpur
MAHARASHTRA
440019
India 
Phone  09890324934  
Fax    
Email  drrajlakshmi1@gmail.com  
 
Source of Monetary or Material Support  
Patient attending Dept of Prosthodontics included in the study 
 
Primary Sponsor  
Name  Dr Rajlakshmi Banerjee 
Address  VSPM DCRC Nagpur 
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 
Dr Rajlakshmi Sujoy Banerjee  VSPMS RDDC&RC   Dept of Prosthodontics, Room no 205, 2nd floor, VSPMS RDDC&RC
Nagpur
MAHARASHTRA 
09890324934

drrajlakshmi1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VSPMS RDDC IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, (2) ICD-10 Condition: K06||Other disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Antioxidant therapy  Antoxid- dose 1 tablet OD for 3 months Oxitard- Dose 1 tablet OD for 3 months 
Comparator Agent  Antioxidant therapy   Effect of two different Antioxidant therapies on the implant stability and crestal bone loss in smokers and non-smokers 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients in the age group of 20-40 years with history of smoking less than 10 cigarettes per day
Patients in the age group of 20-40 years with no history of smoking
Patients with no other history of systemic complications other than the history of smoking
Patients willing to replace missing teeth with implants
Patients indicated for implant placement with healing abutment in single stage.
Patients willing to take part in the study
 
 
ExclusionCriteria 
Details  Patients with other systemic complications like diabetes and other medical conditions other than history of smoking
Patients with the history of smoking not willing to follow protocol for implant placement
Patients indicated for two stage implant surgery will be excluded.
Patients requiring soft or hard tissue augmentation will be excluded from the study.
Patients not willing to take part in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To comparatively evaluate the effect of two different antioxidants on the stability of implants and crestal bone loss in smokers and nonsmokers
 
0 months, 3 months and 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/12/2025 
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="0"
Months="6"
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  

The use of osseointegrated implants as a foundation for the prosthetic replacement of missing teeth has become widespread in the last decade.1 Owing to the remarkable success of dental implants, there has been growing interest in identifying factors associated with implant failure. Given the well-documented deleterious effect of smoking on wound healing after tooth extraction and its association with poor quality bone and periodontal disease, a negative effect of tobacco use on implant success is to be expected. Oxidative stress occurs as a result of an overproduction of ROS (reactive oxygen species) not balanced by an adequate level of antioxidants. ROS are highly reactive molecules which consist of a number of diverse chemical species, including radical and non-radical oxygen species. Many diseases have been linked to oxidative stress including bone diseases among which one of the most important is the osteoporosis. Changes in ROS and/or antioxidant systems seem to be involved in the pathogenesis of bone loss. ROS induce the apoptosis of osteoblasts and osteocytes, and this favours osteoclastogenesis and inhibits the mineralization and osteo-genesis. Antioxidants either directly or by counteracting the action of oxidants contribute to activate the differentiation of osteoblasts, mineralization process and the reduction of osteoclast activity. In fact, a marked decrease in plasma antioxidants was found in aged or osteoporotic women. Therefore, this study was planned to address the gap in knowledge as to whether antioxidant therapy can improve implant stability and reduce crestal bone loss in smokers and non-smokers receiving implant treatment

 
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