NCT06384638

Brief Summary

Virgin Coconut Oil (VCO) is a vegetable oil extracted from coconut fleshcontains unsaturated fatty acids in the form of oleic acid and linoleic acid and flavonoids which function as anti-inflammatory. Periodontitis is an inflammatory disease of the periodontal tissues with a high prevalence worldwide. The main etiology of plaque periodontitis is biofilm containing colonies of pathogenic microorganisms. The aim of the study is to evaluate and compare the effect of scaling and root debridement alone versus the use of topically applied coconut oil as adjunctive to scaling and root debridement in treatment of Stage II and III Grade B periodontitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2022

Typical duration for 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

February 15, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

1.9 years

First QC Date

April 19, 2024

Last Update Submit

April 24, 2024

Conditions

Keywords

Periodontitiscoconut oilscaling and debridement

Outcome Measures

Primary Outcomes (2)

  • clinical parameters

    clinical attachment loss

    3 months

  • clinical parameters

    Probing depth

    3 months

Secondary Outcomes (1)

  • Biological parameters

    3 months

Study Arms (2)

interventional

ACTIVE COMPARATOR

coconut oil as topical application as adjunctive to scaling and root debridement

Biological: topical application of coconut oilOther: scaling and debridement

control

ACTIVE COMPARATOR

scaling and root debridement

Other: scaling and debridement

Interventions

topical application of coconut oil

interventional

scaling and debridement

controlinterventional

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients age group \>35 years without ant systemic disease
  • Willing to take part in the study. Patients with more than 16 natural teeth and have test teeth with both mesial and distal neighboring teeth with periodontitis with clinical attachment loss \>3 mm and radiographic percentage of bone loss/age ranged between 0.25 to 1.
  • Patients with no history of allergies to coconut

You may not qualify if:

  • smokers
  • pregnant
  • lactating women
  • Teeth with both endodontic-periodontal lesion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry at MUST

Giza, 02, Egypt

Location

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitis

Interventions

Tooth ExfoliationDebridement

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of oral medicine, periodontology and oral diagnosis at Misr University for science and technology

Study Record Dates

First Submitted

April 19, 2024

First Posted

April 25, 2024

Study Start

February 15, 2022

Primary Completion

January 16, 2024

Study Completion

February 9, 2024

Last Updated

April 25, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations