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Evaluation of the Effect of Oil Pulling

Primary Purpose

Oral Hygiene, Dental Plaque

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Chlorhexidine

Oil Pulling

Distilled Water

About this trial

This is an interventional prevention trial for Oral Hygiene focused on measuring Chlorhexidine, Oil pulling, Plaque Regrowth model, Coconut oil, Digital spectrophotometer

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Without systemic disease,
Had at least 24 teeth, and
Without fixed or removable prostheses or orthodontic appliances

Exclusion Criteria:

Individuals with a history of systemic or topical oral antimicrobial therapy use in the last 3 months
Individuals with an allergy to any ingredient used in the study
Smokers
Pregnant or breastfeeding women
Individuals with ≥2 mm gingival recession

Sites / Locations

Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Chlorhexidine

Coconut Oil

Black Cumin Oil

Terebinth Oil

Distilled Water

Arm Description

Outcomes

Primary Outcome Measures

Dental Plaque

Plaque scores recorded by using the Quigley-Hein and Turesky plaque index (Q-H).

Secondary Outcome Measures

Tooth Color

The tooth color was determined with a digital spectrophotometer

Full Information

NCT ID

NCT05304338

First Posted

March 22, 2022

Last Updated

March 22, 2022

Sponsor

Ataturk University

1. Study Identification

Unique Protocol Identification Number

NCT05304338

Brief Title

Evaluation of the Effect of Oil Pulling

Official Title

Evaluation of the Effect of Oil Pulling on Dental and Gingival Health

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

October 10, 2021 (Actual)

Primary Completion Date

November 25, 2021 (Actual)

Study Completion Date

January 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The objectives of this study were to evaluate the inhibitory effect on plaque and the tooth discoloration associated with agents used in the chemical plaque control of oil pulling in comparison with chlorhexidine-containing mouthwash and water in a four-day plaque regrowth model. One hundred dentistry students were included in this randomized, parallel-group, placebo-controlled clinical study. In this study, participants were divided into 5 equal groups: Group 1: Gargling with 0.2% chlorhexidine; Group 2: Oil pulling with coconut oil; Group 3: Oil pulling with black cumin oil; Group 4: Oil pulling with terebinth oil; Group 4: Gargling with distilled water. Participants were instructed to refrain from mechanical oral hygiene and rinse only with the allocated mouth rinse during the four-day period. The differences in plaque index, gingival index, and tooth discoloration were evaluated in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Hygiene, Dental Plaque

Keywords

Chlorhexidine, Oil pulling, Plaque Regrowth model, Coconut oil, Digital spectrophotometer

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chlorhexidine

Arm Type

Active Comparator

Arm Title

Coconut Oil

Arm Type

Experimental

Arm Title

Black Cumin Oil

Arm Type

Experimental

Arm Title

Terebinth Oil

Arm Type

Experimental

Arm Title

Distilled Water

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Chlorhexidine

Intervention Description

Gargling with 10 mL 0.2% Chlorhexidine

Intervention Type

Other

Intervention Name(s)

Oil Pulling

Intervention Description

In oil pulling therapy, a tablespoon of edible oil is placed in the mouth and swirled between the teeth for 15 to 20 minutes

Intervention Type

Other

Intervention Name(s)

Distilled Water

Intervention Description

Gargling with 10 mL distilled water

Primary Outcome Measure Information:

Title

Dental Plaque

Description

Plaque scores recorded by using the Quigley-Hein and Turesky plaque index (Q-H).

Time Frame

Day 4

Secondary Outcome Measure Information:

Title

Tooth Color

Description

The tooth color was determined with a digital spectrophotometer

Time Frame

Day 1- Day 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Without systemic disease, Had at least 24 teeth, and Without fixed or removable prostheses or orthodontic appliances Exclusion Criteria: Individuals with a history of systemic or topical oral antimicrobial therapy use in the last 3 months Individuals with an allergy to any ingredient used in the study Smokers Pregnant or breastfeeding women Individuals with ≥2 mm gingival recession

Facility Information:

Facility Name

Ataturk University

City

Erzurum

State/Province

None Selected

ZIP/Postal Code

25240

Country

Turkey

12. IPD Sharing Statement

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Evaluation of the Effect of Oil Pulling

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