Clinical Effect of Chlorhexidine Mouthwash After Periodon... | NCT04223076

Studies
Clinical Effect of Chlorhexidine Mouthwash After Periodontal Surgery

NCT04223076

Sponsor

University of Oslo

Status

Unknown status

Last Update Posted

Jan 13, 2020Actual

Enrollment

31Estimated

Phase

Phase 4

Conditions

Periodontal Diseases
Periodontitis
Dental Plaque

Interventions

Chlorhexidine 0.2%, Corsodyl
Chlorhexidine 0.2%, Curasept

Countries

Norway

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

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2019Actual

Primary Completion Date

Dec 20, 2019Actual

Completion Date

Dec 30, 2020Estimated

First Submitted Date

Jan 7, 2020

First Submission Date that Met QC Criteria

Jan 8, 2020

First Posted Date

Jan 10, 2020Actual

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

Jan 8, 2020

Last Update Posted Date

Jan 13, 2020Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Chlorhexidine is the gold standard of dental plaque prevention. Recent research have demonstrated that 0.2% Chlorhexidine solutions are more effective than 0.12% and 0.06% Chlorhexidine solutions. Several 0.2% solutions are available on the market. This study aimed to compare effectiveness of two commercially available 0.2% chlorhexidine mouthwashes. Patients, that after initial periodontal therapy, had a need for two periodontal surgeries, will be invited to join. After one surgical session, the patient will receive one 0.2% chlorhexidine solution, and after the next surgical session the patient will receive the other 0.2% chlorhexidine solution. Plaque and gingivitis will be recorded, as well as side effects.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chlorhexidine 0.2% mouthwash control	Experimental	Chlorhexidine 0.2%, Corsodyl Intervention rinsing 60 sec twice daily	Drug: Chlorhexidine 0.2%, Corsodyl
Chlorhexidine 0.2% mouthwash with an Anti Discoloring System	Experimental	Chlorhexidine 0.2%, Curasept Intervention rinsing 60 sec twice daily	Drug: Chlorhexidine 0.2%, Curasept

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chlorhexidine 0.2%, Corsodyl	Drug	Comparison of Corsodyl and Curasept	Chlorhexidine 0.2% mouthwash control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plaque index	Dental Plaque	14 days intervention period
Gingival Index	Gingivitis	14 days intervention period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Periodontitis, stage III and IV

Exclusion Criteria:

Uncontrolled diabetes Systemic conditions associated with excessive bleeding Uncontrolled hypertension

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Erik Mauland, DDS	Contact	004747636914		erik.mauland@hotmail.com
Hans Preus, Professor	Contact			h.r.preus@odont.uio.no

Overall Officials

Name	Affiliation	Role
Anne Merete Aass, Professor	University of Oslo	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erik Mauland	Recruiting	Oslo		0574	Norway

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010510	Periodontal Diseases
D010518	Periodontitis
D003773	Dental Plaque

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D003741	Dental Deposits
D014076	Tooth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002710	Chlorhexidine

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided