Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04737798 |
| Other study ID # |
BaskentU7 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2, 2020 |
| Est. completion date |
April 30, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
Baskent University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Oil pulling" or "oil swishing" originates from ancient Ayurvedic medicine in India and now
practiced in other parts of the world as a form of complementary and alternative medicine. It
has been described as Kavalagraha or Gandhoosha in the ayurvedic texts of Charaka Samhita and
Sushruta Samhita. It is a procedure that involves swishing oil in the mouth a period of 15
min, before spitting it out.
In addition to its systemic benefits, oil pulling therapy has also benefits on oral health.
The oil pulling therapy can be performed by using edible oils like sesame oil, sunflower oil
and coconut oil. However, there is only one study in the literature comparing the effect of
oil pulling therapy using coconut oil versus sesame oil on plaque-induced gingivitis and the
results were in favor of coconut oil.
In order to clarify the gap in the literature on this field, this study was designed to
compare the plaque-inhibiting effects of oil pulling therapy with sesame oil or coconut oil
using 4- day plaque regrowth study model.
Description:
The study is conducted as an observer masked, cross over design with a single-center where
the participants were randomly allocated to groups. Before the initiation of the study period
all participants underwent thorough scaling and polishing of the teeth by both hand and
ultrasonic instruments to remove all plaque, calculus and stain and were instructed in how to
maintain oral hygiene. This phase considered as a preparatory period by the end of this
period all participants obtained healthy gingiva clinically.
The randomization of the participants were provided by closed envelop system (BM). The
conductors of the study were blinded to the mouthrinses received by participants. The tested
products and regimens of use are shown in Table 1. Identical coded bottles were used to fill
the mouthrinses. The bottles also had stickers on explaining the usage instructions. On the
first day of each study period, to confirm all patients to have plaque score of 0 at the
baseline, erythrosine was applied to all teeth and then scaling and polishing to remove
plaque and extrinsic stain and disclosing of the teeth was performed. All tooth cleaning
applications (other rinse, chewing gum or toothbrushing / toothpaste) were forbidden for 4
days of study protocol and rinsing regimen was performed. The tested agents included the
following: 1) Sesame oil (10 ml, twice daily 15-20 minute) 2) Coconut oil (10 ml, twice daily
15-20 minute). Participants were instructed to perform the mouthrinsing after breakfast and
dinner and to avoid rinsing, eating and drinking following hour after rinsing. Even though
the mouthrinses were in provided identical bottles and patients were not informed about the
products however due to the taste and color differences of the products total subject
blindness could not be achieved.
On day 5 (Friday), each subject was scored for staining using Lobene stain index following an
oral soft tissue examination. Following the satin scoring erythrosine disclosing was
performed and Turesky et al. modification of the Quigley and Hein index was used for plaque
scoring. All buccal and lingual surfaces of all fully erupted permanent teeth, with the
exception of the third molars were scored for stain and plaque. Six sites of each teeth were
also used to score Gingival Index (GI) and bleeding on probing (BOP). All clinical
examinations were performed by a single trained and calibrated clinician (YS) who was masked
to the study.
Following the recording of clinical parameters, all plaque and tooth stain (if present) were
removed by polishing and washout period of 14 days was awaited after the second phase of the
study. For the washout period, the subjects were instructed to go on to their routine oral
hygiene habits. Following this period the procedures explained before were repeated until
each participant used each of the rinses for the second phase of the study.
Standardized questionnaire were filled by the participants in order to evaluate their
attitudes and occurrence of adverse effects with regard to the product used at the end of
each phase. The questions evaluated the flavor of the mouthrinse, the alteration in the taste
of food and drinks, the perception of the plaque reduction, the staining that the mouthrinse
created, the feeling to create nausea. Five point Likert type scale was used to collect the
responses to the questions which ranged from 1- "very negative" to 5- "very positive"
excluding the question about the preference of the product. At the end of each phase
participants were asked to bring the bottles to control the remaining mouthrinses in order to
control the compliance of the participants.
