| CTRI Number |
CTRI/2024/03/064656 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
02/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Coconut Oil And Chlorhexidine Mouth Washes On Bad Breath In
Patients With Gum Diseases |
|
Scientific Title of Study
|
Effect Of Coconut Oil And Chlorhexidine Mouth Rinses On Halitosis In
Patients With Gingivitis
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kotasindhu |
| Designation |
PG Stuent |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Room no. 8, second floor, Sibar Institute of Dental Sciences,
Takkellapadu, Guntur. Room no. 8, second floor, Sibar Institute of
Dental Sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9866889394 |
| Fax |
|
| Email |
kotasindhu1718@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRavindranath |
| Designation |
Professor |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Room no. 8, second floor, Sibar Institute of Dental Sciences,
Takkellapadu, Guntur. Room no. 8, second floor, Sibar Institute of
Dental Sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9849222259 |
| Fax |
|
| Email |
ravident69@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
kotasindhu |
| Designation |
PG Stuent |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Room no. 8, second floor, Sibar Institute of Dental Sciences,
Takkellapadu, Guntur. Room no. 8, second floor, Sibar Institute of
Dental Sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9866889394 |
| Fax |
|
| Email |
kotasindhu1718@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 8 department of periodontics second floor sibar institute of dental sciences Takkellapadu guntur pincode 522509 |
|
|
Primary Sponsor
|
| Name |
Kotasindhu |
| Address |
room no. 8, second floor, sibar institute of dental sciences,
Takkellapadu, Guntur-522509 |
| 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 |
| DrKotasindhu |
SIBAR INSTITUTE OF DENTAL SCIENCES |
ROOM NO.8, DEPT OF
PERIODONTICS,
SECOND FLOOR,
SIBAR INSTITUTE OF
DENTAL SCIENCES,
TAKKELLAPADU,
GUNTUR -- Guntur
ANDHRA PRADESH
Guntur
ANDHRA PRADESH |
9866889394
kotasindhu1718@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC- SIBAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chlorhexidine mouthwash |
Chlorhexidine mouthwash twice
daily for 1 minute will be
advised to each patient in
chronic gingivitis patients after
non surgical periodontal therapy
in control group |
| Intervention |
coconut oil |
virgin coconut oil twice daily for
8-10 minutes will be advised to
each patient in chronic gingivitis
patients after non surgical
periodontal therapy in test group |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
apparently healthy individuals,patients who are willing to give informed consent , age 25 to 55 years,probing depth less than 3 mm in atleast 24 permanent teeth , gingival and plaque index is equal to 1 in more than 10 percent of sites
|
|
| ExclusionCriteria |
| Details |
1.Histroy of systemic diseases.
2.Smoking.
3.Previous history of any periodontal treatment before 6 months.
4.Pregnancy and lactating woman.
5.Under medication that alter the periodontal status.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate halitosis and periodontal
parameters at baseline,15 days and 1 month
after NSPT
with virgin coconut oil mouthwash.
2. To evaluate halitosis and periodontal
parameters at baseline,15 days and 1 month
after NSPT
with chlorhexidine mouthwash |
baseline,15days,1month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate halitosis and periodontal
parameters at baseline,15 days and 1 month
after NSPT
with virgin coconut oil mouthwash.
2. To evaluate halitosis and periodontal
parameters at baseline,15 days and 1 month
after NSPT
with chlorhexidine mouthwash. |
baseline,15days,1month
|
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Study procedure : A total of 60 patients complains of halitosis and diagnosed with chronic gingivitis
will be selected into the study.The patients were randomly divided into 2 groups according to
inclusion and exclusion criteria. Group I: NSPT + virgin coconut oil mouthwash(n=30) Group II: NSPT + virgin chlorhexidine mouthwash(n=30) Methodology:
At baseline Gingival index (GI), Plaque index (PI), Organoleptic scoring index will be recorded and oral prophylaxis with oral hygiene instructions will be given followed by distribution of respective
mouthwashes. Directions of usage of mouth wash will be advised to each patient as per the
manufacturer recommendations .For Group I subjects, 10 ml (one tablespoon) of virgin coconut oil
twice daily for 8-10 minutes ,where as for Group II subjects, 10 ml of 0.2% Chlorhexidine
mouthwash twice daily for 1 minute. All the parameters will be recorded at 15 days and 30 days
recall follow-up intervals. |