Effect of Probiotics on Oral Homeostasis During Oral Hygi... | NCT05268757

Studies
Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation

NCT05268757

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Aug 23, 2022Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Gingivitis

Interventions

Oral hygiene discontinuation

Countries

Denmark

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

Aug 2022

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

Jan 5, 2022Actual

Primary Completion Date

Jun 1, 2022Actual

Completion Date

Jun 1, 2022Actual

First Submitted Date

Feb 24, 2022

First Submission Date that Met QC Criteria

Feb 24, 2022

First Posted Date

Mar 7, 2022Actual

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

Aug 22, 2022

Last Update Posted Date

Aug 23, 2022Actual

Name	Class
Deerland Probiotics and Enzymes	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

The present study is a double-blinded randomized clinical trial with a duration of 28 days.

Detailed Description

The present study is a double-blinded randomized clinical trial with a duration of 28 days.

80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline.

The intervention is oral hygiene discontinuation, which will be applied at baseline and continue through day 14, followed by 14 days with regular oral care.

Clinical measurements and sampling will be performed at baseline, day 14 and day 28

Primary endpoint: Changes in microbial composition.

Secondary endpoints: Changes in clinical and immunological parameters

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic	Experimental	In this group participants will receive probiotic supplements twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care).	Behavioral: Oral hygiene discontinuation
Placebo	Placebo Comparator	In this group participants will receiveplacebo twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care).	Behavioral: Oral hygiene discontinuation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral hygiene discontinuation	Behavioral	Oral hygiene discontinuation for 14 days followed by 14 days of regular oral care	Placebo Probiotic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in microbial composition in dental	Changes in alpha and beta diversity of microbial composition	Baseline vs. Day 14 and Day 28

Secondary Outcomes

Measure	Description	Time Frame
Changes in clinical parameters	Changes in levels of dental plaque and gingival inflammation	Baseline vs. Day 14 and Day 28

Other Outcomes

Measure	Description	Time Frame
Changes in salivary levels of inflammatory cytokines	Changes in mean salivary levels of selected inflammatory cytokines	Baseline vs. Day 14 and Day 28

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- age > 18 yrs.

Exclusion Criteria:

Presence of oral diseases i.e. gingivitis, periodontitis and dental caries
Current smokers
Any systemic diseases and current use of any medication with known effect on oral health
Use of systemic antibiotics within the latest three months
Age < 18 yrs., and age > 30 yrs.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

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 Copenhagen, Department of Odontology		Copenhagen		2200	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005891	Gingivitis

Ancestor Terms

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Quadruple

Masking Description

Computerized randomization only known to the principal investigator, who are not directly involved in data collection or data analysis

Who Masked

ParticipantCare ProviderInvestigatorOutcomes Assessor