Periodontal DiseasesPhase 4NCT04223076
Clinical Effect of Chlorhexidine Mouthwash After Periodontal Surgery
A Phase 4 study testing Chlorhexidine 0.2%, Corsodyl and Chlorhexidine 0.2%, Curasept in people with Periodontal Diseases and Periodontitis, run by University of Oslo at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Periodontal Diseases, Periodontitis, Dental Plaque
- What is being tested?
- Chlorhexidine 0.2%, Corsodyl and Chlorhexidine 0.2%, Curasept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteNorway
- Study dates
- 20 Mar 2019to 30 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Periodontitis, stage III and IV
Who cannot join
- Uncontrolled diabetes Systemic conditions associated with excessive bleeding Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
Hans Preus, Professor contact
Norway1 site, 1 recruiting
- Recruiting
Erik Mauland
Oslo, 0574
Erik Mauland, 47636914, erik.mauland@hotmail.com
About this study
Official title: Clinical Performance of Two 0.2% Chlorhexidine Mouth Rinses After Periodontal Surgery. A Blinded, Intra-individual Cross-over Clinical Trial
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.
- Conditions
- Periodontal Diseases, Periodontitis, Dental Plaque
- Being tested
- Chlorhexidine 0.2%, Corsodyl, Chlorhexidine 0.2%, Curasept
- Keywords
- Periodontal Index
- Medical subject headings
- Periodontal Diseases, Periodontitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine 0.2%, CorsodylDrug
Comparison of Corsodyl and Curasept
Chlorhexidine 0.2%, CuraseptDrug
Chlorhexidine 0.2% mouthwash with an Anti Discoloring System (ADS)
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine 0.2% mouthwash control | Experimental | Chlorhexidine 0.2%, Corsodyl Intervention rinsing 60 sec twice daily Receives: 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 Receives: Drug: Chlorhexidine 0.2%, Curasept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index
Dental Plaque
Measured: 14 days intervention period
Gingival Index
Gingivitis
Measured: 14 days intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start20 Mar 2019
- Primary completion20 Dec 2019
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Intra individual cross-over, double intervention
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Mauland, University of Oslo
- Investigators
- Anne Merete Aass, Professor, Study chair, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223076
- Sponsor's protocol ID
- 2020/121314
- Status last verified
- Jan 2020
- First submitted
- 7 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Two 0.2% Chlorhexidine Mouth Rinses After Periodontal Surgery. A Blinded, Intra-individual Cross-over Clinical Trial
- ClinicalTrials.gov ID
- NCT04223076
- Acronym / sponsor ID
- 2020/121314
- Conditions
- Periodontal Diseases, Periodontitis, Dental Plaque
- Keywords
- Periodontal Index
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intra individual cross-over, double intervention
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine 0.2% mouthwash control | Experimental | Drug: Chlorhexidine 0.2%, CorsodylChlorhexidine 0.2%, Corsodyl Intervention rinsing 60 sec twice daily |
| Chlorhexidine 0.2% mouthwash with an Anti Discoloring System | Experimental | Drug: Chlorhexidine 0.2%, CuraseptChlorhexidine 0.2%, Curasept Intervention rinsing 60 sec twice daily |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Periodontitis, stage III and IV
Key exclusion criteria (1 listed)
- Uncontrolled diabetes Systemic conditions associated with excessive bleeding Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine 0.2%, CorsodylComparison of Corsodyl and Curasept | Drug | Chlorhexidine 0.2% mouthwash control |
| Chlorhexidine 0.2%, CuraseptChlorhexidine 0.2% mouthwash with an Anti Discoloring System (ADS) | Drug | Chlorhexidine 0.2% mouthwash with an Anti Discoloring System |
Primary outcome
Plaque index
Time frame: 14 days intervention period
Dental Plaque
Gingival Index
Time frame: 14 days intervention period
Gingivitis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Preus, Professor contact
Anne Merete Aass, Professor study chair
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorhexidine 0.2%, Corsodyl and Chlorhexidine 0.2%, Curasept in people with Periodontal Diseases and Periodontitis, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erik Mauland, DDS (004747636914, erik.mauland@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index (time frame: 14 days intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.