NCT07175090

Brief Summary

This study was based on testing a new natural mouthwash with coconut oil and xylitol as active agents to a placebo rinse on new periodontal parameters

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2024

Shorter than P25 for early_phase_1

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

June 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
Last Updated

September 16, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

September 4, 2025

Last Update Submit

September 11, 2025

Conditions

Periodontitis, AdultMouthwash

Outcome Measures

Primary Outcomes (1)

  • Improvement of gingival appearance

    The gingival index will be assessed before and after mouthrinse use

    Three weeks of mouthrinse use

Secondary Outcomes (1)

  • Gingival bleeding

    Three weeks after mouthrinse use

Study Arms (2)

Group A

PLACEBO COMPARATOR
Other: Placebo

Group B

ACTIVE COMPARATOR
Combination Product: Coconut oil

Interventions

Coconut oilCOMBINATION_PRODUCT

The rinse is used three times a day during three weeks

Group B
PlaceboOTHER

Inactive ingredients with same taste and colour

Group A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Periodontitis grade I, II, III

You may not qualify if:

  • less than 20 teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Prishtina Dentistry School

Pristina, 10000, Kosovo

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Coconut Oil

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsPlant OilsOils

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University assistant

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 16, 2025

Study Start

June 1, 2024

Primary Completion

February 1, 2025

Study Completion

May 1, 2025

Last Updated

September 16, 2025

Record last verified: 2025-04

Locations

KO(1)