NCT05304338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

March 22, 2022

Last Update Submit

March 22, 2022

Conditions

Keywords

ChlorhexidineOil pullingPlaque Regrowth modelCoconut oilDigital spectrophotometer

Outcome Measures

Primary Outcomes (1)

  • Dental Plaque

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

    Day 4

Secondary Outcomes (1)

  • Tooth Color

    Day 1- Day 4

Study Arms (5)

Chlorhexidine

ACTIVE COMPARATOR
Drug: Chlorhexidine

Coconut Oil

EXPERIMENTAL
Other: Oil Pulling

Black Cumin Oil

EXPERIMENTAL
Other: Oil Pulling

Terebinth Oil

EXPERIMENTAL
Other: Oil Pulling

Distilled Water

PLACEBO COMPARATOR
Other: Distilled Water

Interventions

Gargling with 10 mL 0.2% Chlorhexidine

Chlorhexidine

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

Black Cumin OilCoconut OilTerebinth Oil

Gargling with 10 mL distilled water

Distilled Water

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, None Selected, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

March 22, 2022

First Posted

March 31, 2022

Study Start

October 10, 2021

Primary Completion

November 25, 2021

Study Completion

January 21, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations