NCT04223076

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

January 7, 2020

Last Update Submit

January 8, 2020

Conditions

Keywords

Periodontal Index

Outcome Measures

Primary Outcomes (2)

  • Plaque index

    Dental Plaque

    14 days intervention period

  • Gingival Index

    Gingivitis

    14 days intervention period

Study Arms (2)

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

Comparison of Corsodyl and Curasept

Chlorhexidine 0.2% mouthwash control

Chlorhexidine 0.2% mouthwash with an Anti Discoloring System (ADS)

Chlorhexidine 0.2% mouthwash with an Anti Discoloring System

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Periodontitis, stage III and IV

You may not qualify if:

  • Uncontrolled diabetes Systemic conditions associated with excessive bleeding Uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erik Mauland

Oslo, 0574, Norway

RECRUITING

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitisDental Plaque

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesDental DepositsTooth Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Anne Merete Aass, Professor

    University of Oslo

    STUDY CHAIR

Central Study Contacts

Erik Mauland, DDS

CONTACT

Hans Preus, Professor

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Intra individual cross-over, double intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 10, 2020

Study Start

March 20, 2019

Primary Completion

December 20, 2019

Study Completion

December 30, 2020

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

Locations