Evaluation of Coconut Oil Mouth Rinse on Periodontal Para... | NCT07175090

Studies
Evaluation of Coconut Oil Mouth Rinse on Periodontal Parameters

NCT07175090

Sponsor

University of Pristina

Status

Completed

Last Update Posted

Sep 16, 2025Actual

Enrollment

120Actual

Phase

Early Phase 1

Conditions

Periodontitis, Adult
Mouthwash

Interventions

Coconut oil
Placebo

Countries

Kosovo

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Actual

Primary Completion Date

Feb 1, 2025Actual

Completion Date

May 1, 2025Actual

First Submitted Date

Sep 4, 2025

First Submission Date that Met QC Criteria

Sep 11, 2025

First Posted Date

Sep 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2025

Last Update Posted Date

Sep 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Placebo Comparator		Other: Placebo
Group B	Active Comparator		Combination Product: Coconut oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coconut oil	Combination Product	The rinse is used three times a day during three weeks	Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of gingival appearance	The gingival index will be assessed before and after mouthrinse use	Three weeks of mouthrinse use

Secondary Outcomes

Measure	Description	Time Frame
Gingival bleeding	The presence of gingival bleeding will be assessed before and after mouthrinse use	Three weeks after mouthrinse use

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Periodontitis grade I, II, III

Exclusion Criteria:

less than 20 teeth

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Prishtina Dentistry School		Pristina		10000	Kosovo

Condition Browse Module

MeSH Terms

ID	Term
D055113	Chronic Periodontitis

Ancestor Terms

ID	Term
D010518	Periodontitis
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000074263	Coconut Oil

Ancestor Terms

ID	Term
D004041	Dietary Fats
D005223	Fats
D008055	Lipids
D010938	Plant Oils
D009821

Browse Leaves

Not provided

Browse Branches

Not provided