| 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
|
|
|
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
|
|
|
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 |