| CTRI Number |
CTRI/2017/10/010185 [Registered on: 25/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
20/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
to evaluate effect of nonsurgical periodontal therapy on Vitamin C and total antioxidant levels |
|
Scientific Title of Study
|
“Effect of Non Surgical Periodontal Therapy and Vitamin C Supplementation on Total Antioxidant Capacity in Patients with Chronic Generalised Periodontitis – A Randomized Controlled Trialâ€. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swet Nisha |
| Designation |
Postgraduate student |
| Affiliation |
JSS Dental COllege and Hospital |
| Address |
JSS Dental College and Hospital room no 9,department of periodontology bannimantap mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
9620947217 |
| Fax |
|
| Email |
swetnisha1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avinash BS |
| Designation |
Reader |
| Affiliation |
JSS Dental COllege and Hospital |
| Address |
JSS Dental College and Hospital room no 9 department of periodontology Bannimantap Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9945047223 |
| Fax |
|
| Email |
dravinashbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swet Nisha |
| Designation |
Postgraduate student, |
| Affiliation |
JSS Dental COllege and Hospital |
| Address |
JSS Dental COllege and Hospital room no9 department of periodontology SS Nagar Bannimantap Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9620947217 |
| Fax |
|
| Email |
swetnisha1@gmail.com |
|
|
Source of Monetary or Material Support
|
| self funded
Dr Swet Nisha JSS Dental College ladies hostel room no. 48 bannimantap mysore karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Swet Nisha |
| Address |
Jss Dental college hostel,Room No. 48 ,Dept of Periodontology Mysore 570015 |
| Type of Sponsor |
Other [self funded] |
|
|
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 swet nisha |
JSS dental college and hospital |
Department of Periodontology,room no.9 Division of oral research .Mysore -570015
Mysore
KARNATAKA |
9620947217
swetnisha1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethical Committee-J.S.S Dental College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1-The Control group
|
A Randomized Controlled Trial Concurrent parallel design (Both Intra and Inter groups)
Subjects with Chronic Periodontitis
The Control group will include 25 subjects receiving Scaling and Root Planing only.
|
| Intervention |
Vitamin C |
The Test group will include 25 subjects receiving Scaling and Root Planing with Vitamin C Supplementation 500 mg once daily for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who are willing to give inform consent.
2. Subjects in the age group of 25 – 55 years.
3. Subjects who have at least 20 functional teeth.
4. Subjects with Chronic Generalised Periodontitis
|
|
| ExclusionCriteria |
| Details |
1. Subjects who are unwilling to give inform consent.
2. Subjects who are having Systemic diseases or are under regular medications for any systemic diseases.
3. Subjects who are on Anti-inflammatory/Anti-microbial therapy/mouthwashes or any vitamin supplements in the past 3 months.
Subjects who have undergone Periodontal Therapy in the last 6 months.
Pregnant or Lactating women.
Subjects who give a history of previous or current Smoking.
Subjects with Special Dietary requirements
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the effects of Non Surgical Periodontal Therapy with and without Vitamin C supplementation on Total Antioxidant Capacity |
baseline -saliva and serum sample collection
2 weeks scaling and root planing completion and Vitamin C-500 mg supplementation for test
group .
3 months - saliva and serum sample collection . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare plaque index , gingival index , clinical attachment level before after non surgical periodontal therapy |
baseline - saliva and serum sample collection
2 weeks - scaling and root |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/06/2015 |
| Date of Study Completion (India) |
16/05/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Primary purpose of the protocol - To Compare the Effects of Non Surgical Periodontal Therapy with and without Vitamin C supplementation on Total Antioxidant Capacity . Introduction - Chronic Periodontitis is a disease of microbial infection which leads to tissue damage as a result of complex interaction between host immune response.The role of reactive oxygen species have been implicated in periodontal destruction . measurement of total antioxidant capacity will be a representative of total antioxidant capacity of serum and saliva. Materials and method - 25 healthy subjects will be enrolled in control group 25 chronic periodontitis patients will be enrolled in test group Test group - it will recieve scaling and root planing and vitamin C supplementation - 500 mg for 3 months at base line - saliva and serum samples will be taken for both the group for measurement of total antioxidant capacity . at 3 months follow up saliva and serum samples will be re evaluated for test group . study design - Randomised concurrent parallel controlled trial . Statistical analysis - descriptive statistics , Independent t test and paired sample t test will be done. |