| CTRI Number |
CTRI/2018/02/011738 [Registered on: 06/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
30/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effectiveness of Oil mouth rinsing and chlorhexidine mouth rinsing on inflammation of gums.
|
|
Scientific Title of Study
|
Comparative Efficacy of Oil Pulling and Chlorhexidine on
Plaque Induced Gingivitis
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Sharda |
| Designation |
Post-Graduate Student |
| Affiliation |
SDM COLLEGE OF DENTAL SCIENCES AND HOSPITAL |
| Address |
SDM College of Dental Sciences and Hospital,
Department of Public Health Dentistry.
Dharwad
KARNATAKA
580009
India |
| Phone |
9731278744 |
| Fax |
|
| Email |
shwetasharda1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Preetha J Shetty |
| Designation |
Professor and Head of the Department |
| Affiliation |
SDM COLLEGE OF DENTAL SCIENCES AND HOSPITAL |
| Address |
SDM College of Dental Sciences and Hospital,
Department of Public Health Dentistry.
Dharwad
KARNATAKA
580009
India |
| Phone |
9845009979 |
| Fax |
|
| Email |
shetty.preetha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Sharda |
| Designation |
Post Graduate Student |
| Affiliation |
SDM COLLEGE OF DENTAL SCIENCES AND HOSPITAL |
| Address |
SDM College of Dental Sciences and Hospital,
Department of Public Health Dentistry.
Dharwad
KARNATAKA
580009
India |
| Phone |
9731278744 |
| Fax |
|
| Email |
shwetasharda1989@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHWETA SHARDA
SDM College of Dental Sciences and Hospital,
Room No 10,
Sattur, Dharwad. |
|
|
Primary Sponsor
|
| Name |
SHWETA SHARDA |
| Address |
SDMCDSH,
DHARWAD,
KARNATAKA. |
| Type of Sponsor |
Other [] |
|
|
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 |
| SHWETA SHARDA |
SDM College of Dental Sciences and Hospital |
Dept of Public Health Dentistry, Room No. 10,
Sattur.
Dharwad
KARNATAKA |
9731278744
shwetasharda1989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMCDSH-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Plaque Induced Gingivitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.12% CHLORHEXIDINE |
Commercially available 0.12% chlorhexidine was used in this study. The patients were asked to brush their teeth using the given tooth paste and tooth brush. After 30 minutes of brushing they were asked to take one table spoon (roughly 10 mL) of the allotted product, thoroughly rinse their mouth for 30 seconds and expectorate the mouthwash into the sink. The patients were asked to practice this twice a day – in the morning after waking up and at night just before sleeping.
The subjects were recalled after 15 days and 30 days ofusage of the assigned products and were evaluated by the same calibrated dental examiner for gingival status. |
| Intervention |
COCONUT OIL |
Virgin Coconut oil was used in this study. Patients were instructed to take one table spoon (roughly 10 mL) of the allotted product, thoroughly rinse their mouth for 3-5 minutes and expectorate the oil into the sink. After rinsing their mouth with the allotted product, the patients were asked to brush their teeth using the given tooth paste and tooth brush. The patients were asked to practice this twice a day – in the morning after waking up and at night just before sleeping.
The subjects were recalled after 15 days and 30 days of usage of the assigned products and were evaluated by the same calibrated dental examiner for gingival status. |
| Intervention |
SESAME OIL |
Virgin Sesame oil was used in this study. Patients were instructed to take one table spoon (roughly 10 mL) of the allotted product, thoroughly rinse their mouth for 3-5 minutes and expectorate the oil into the sink. After rinsing their mouth with the allotted product, the patients were asked to brush their teeth using the given tooth paste and tooth brush. The patients were asked to practice this twice a day – in the morning after waking up and at night just before sleeping.
The subjects were recalled after 15 days and 30 days usage of the assigned products and were evaluated by the same calibrated dental examiner for re-evaluation of the gingival status. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
1. A minimum of 20 sound natural teeth with scorable facial and lingual surfaces.
2. Willingness to read, understand and sign the informed consent form.
3. Male and female subjects between 18-50 years in good general health.
4. Subject with good periodontal health with pockets < 6mm.
5. A gingival index score of ≥1.0.
6. A plaque index score of ≥1.5.
7. Availability for the entire study duration.
|
|
| ExclusionCriteria |
| Details |
1. Destructive periodontal disease.
2. Significant soft tissue pathology, systemically related gingival enlargement / severe gingivitis.
3. History of diabetes, hepatic, renal disease or other serious medical condition and transmissible disease.
4. Orthodontic appliance or any kind of fixed or removable appliances.
5. History of allergies to dental products or their ingredients.
6. Pregnant and breast feeding women.
7. History of adverse habits like smoking and tobacco chewing.
8. Undergoing antibiotic, steroid therapy or any anti-inflammatory drugs in the preceding month.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingivitis - measured by Modified Loe and Silness Gingival Index. |
15th day and 30th day post-intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dental Plaque - Measured by Tureskey Glickman and Gilmore modification of Quigley Hen Plaque Index. |
15th day and 30th day post intervention. |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
05/07/2016 |
| Date of Study Completion (India) |
25/08/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
This research results shall be sent to relevant journals for publication after registration of the trial in CTRI. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background and Objectives: Mechanical plaque removal is not sufficient
to eliminate gingival inflammation. Studies show Chlorhexidine to be most effective adjunct in
treating gingivitis. However, due to its reported side effects of tooth
discoloration and altered taste sensation, equally effective herbal
alternatives with minimal side-effects are now being explored. Ayurvedic text
claims oil pulling to be a highly effective adjunct to reduce gingival
inflammation. Due to the limited studies that have been documented on oil
pulling therapy for reducing gingival inflammation, more clinical trials are
needed to prove its efficacy before it can be recommended as an effective
adjunct. This study was thus conducted to compare the efficacy of oil pulling
with chlorhexidine on plaque induced gingivitis.
Methodology: This
randomized, examiner blind, parallel 3-cell study was conducted with a follow
up period of 30 days. At the initial visit, the gingival and plaque scores in
78 subjects were recorded using Loe and Silness Gingival index and Turesky,
Gilmore, Glickman modification of Quigley Hein plaque index respectively. This
was followed by a random allocation of the study subjects into 3 groups:
Coconut Oil, Sesame Oil and 0.12% Chlorhexidine mouthrinse. The subjects were
subsequently recalled after 15 days and 30 days for re-evaluation. The
data recorded was subjected to one-way ANOVA test, Schiffe post hoc test and
Student ttest using SPSS version 19.0 software.
Results: The mean percentage reduction in
gingivitis scores after a 30 day period in subjects using Coconut Oil was
24.84%, in Sesame Oil was 11.74% and in 0.12% Chlorhexidine was 24.91%. Coconut
oil was seen to be as effective as 0.12% Chlorhexidine in reducing gingivitis
(p>0.05) but sesame oil showed a statistically significant difference as
compared to chlorhexidine (p<0.05).
Interpretation and Conclusion: Oil pulling using Coconut Oil is as
efficacious as Chlorhexidine in reducing plaque induced gingivitis. |