| CTRI Number |
CTRI/2024/05/067680 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Determinining the effect of mouthwash containing green tea in reducing the gum disease in patients |
|
Scientific Title of Study
|
“Effect of mouthwash containing green tea extract on patients with moderate periodontitis- A Clinical studyâ€
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surya p |
| Designation |
post graduate |
| Affiliation |
karpaga vinayaga institute of dental sciences |
| Address |
Room no .7,Department of periodontology,
karpaga vinayaga institute of dental sciences,
GST road,
chinna kolambakkam,
Palyanoor (PO),
chengalpattu (DT)
Madhuranthagam (TK)
Room no .7,Department of periodontology,
karpaga vinayaga institute of dental sciences,
GST road,
chinna kolambakkam,
Palyanoor (PO),
chengalpattu (DT)
Madhuranthagam (TK) -603308
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
7708528770 |
| Fax |
|
| Email |
suryaperiomds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr . Dhivakar C.P |
| Designation |
Professor |
| Affiliation |
karpaga vinayaga institute of dental sciences |
| Address |
Room no 7,
Third floor,
Department of Periodontology,
karpaga vinayaga institute of dental sciences,
GST road,
chinna kolambakkam,
Palyanoor (PO),
chengalpattu (DT)
Madhuranthagam (TK)
Room no 7,
Third floor,
Department of Periodontology,
karpaga vinayaga institute of dental sciences,
GST road,
chinna kolambakkam,
Palyanoor (PO),
chengalpattu (DT)
Madhuranthagam (TK)-603308
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
7708528770 |
| Fax |
|
| Email |
drdhivakarperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surya p |
| Designation |
Post graduate |
| Affiliation |
karpaga vinayaga institute of dental sciences |
| Address |
Room no 7,
Third floor,
Department of periodontology,
karpaga vinayaga institute of dental sciences,
GST road,
chinna kolambakkam,
Palyanoor (PO),
chengalpattu (DT)
Madhuranthagam (TK)
TAMIL NADU
603308
India |
| Phone |
7708528770 |
| Fax |
|
| Email |
suryaperiomds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karpaga vinayaga institute of dental sciences,
GST road,
chinna kolambakkam,
Palyanoor (PO),
chengalpattu (DT)
Madhuranthagam (TK)-603308
Tamilnadu
India
|
|
|
Primary Sponsor
|
| Name |
karpaga vinayaga institute of dental sciences |
| Address |
Room no : 7
Third floor,
Department of periodontology,
Karpaga vinayaga institute of dental sciences,
GST road,
chinna kolambakkam,
Palyanoor (PO),
chengalpattu (DT)
Madhuranthagam (TK)-603308 |
| Type of Sponsor |
Research institution |
|
|
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 Surya P |
Karpaga Vinayaga Institute Of Dental Sciences |
Room no: 7
Third floor,
Department of periodontology,
Karpaga Vinayaga Institute Of Dental Sciences,
GST road,
chinna kolambakkam,
Palyanoor (PO),
chengalpattu (DT)
Madhuranthagam (TK)-603308
Kancheepuram
TAMIL NADU |
7708528770
suryaperiomds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Karpaga Vinayaga Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Green tea mouthwash |
Advising patients to use 15 ml of mouthwash containing green tea extract for 3 months and evaluating the parameters |
| Comparator Agent |
placebo mouthwash -distilled water |
Patients from other group are advised use distilled water for 3 months as mouthwash and parameters are evaluated |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Systemically healthy individuals
2)Periodontitis patients with
probing pocket depths 4 mm - 6mm
|
|
| ExclusionCriteria |
| Details |
1)Individuals with any form of systemic illness
2)Smokers
3)Pregnant and lactating women
4)Those individuals who had undergone recent periodontal treatment (within 6 months prior to the study)
•Individuals who was not on antibiotics and not taken any other commercial mouthwash
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To Compare the Bleeding on probing (BOP), Probing depth (PD),Clinical Attachment Level (CAL) before and after using Green Tea Mouthwash
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. Comparison of Clinical Parameters –Inflammation, patient compliance between the two groups |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/05/2024 |
| 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 Yet Recruiting |
| 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
|
Green tea has antimicrobial and non-inflammatory properties.the aim of the study is to compare the Bleeding
on probing (BOP), Probing depth (PD),Clinical Attachment Level (CAL) before and
after using Green Tea Mouthwash.15 patients in each group were selected according to the inclusion
criteria from patients attending the outpatient department of Karpaga Vinayaga
Institute of Dental Sciences. The subjects were allocated into two groups and advised to use given mouthwash daily .After 15 days the
parameters were calculated and datas were analyzed.
|