This Study Evaluated the Effectiveness of Chlorhexidine Mouthrinse on Subgingival MicrobiotaPhase 4NCT01213550
Effects Of Chlorhexidine Mouthrinse On Peridontopathogens: A Randomized, Placebo-Controlled Study
A Phase 4 study testing Chlorhexidine gluconate in people with This Study Evaluated the Effectiveness of Chlorhexidine Mouthrinse on Subgingival Microbiota, run by Ege University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the therapeutic effectiveness of chlorhexidine mouthrinse on gingival inflammation and subgingival microbiota in addition to daily mechanical plaque control in a population with established gingivitis. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- This Study Evaluated the Effectiveness of Chlorhexidine Mouthrinse on Subgingival Microbiota
- What is being tested?
- Chlorhexidine gluconate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Mar 2006to Dec 2007
- 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 45 years
- All sexes
- Adult
Who may be able to join
- 18-45 years old male or female with gingivitis associated with dental plaque, no clinical signs of destructive periodontal disease, clinical attachment loss < 3mm, a minimum of 20 teeth (teeth that have gross caries, were fully crowned or extensively restored, orthodontic banded, abutments, or third molars were not included in the tooth count).
Who cannot join
- use of tobacco products, history or current manifestation of systemic disease which could impair immune response such as diabetes mellitus, immunological disorders, hepatitis and HIV infections, use of antibiotic or anti-inflammatory or immunosuppressive drugs during 3 months period prior to the start of the trial, periodontal therapy during the last 3 month, pregnancy or lactation and oral contraceptives usage.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ege U School of Dentistry
Izmir, Bornova, 35100
Ege University School of Dentistry Dep of Periodontology
Izmir, Bornova, 35100
About this study
The aim of this study is to evaluate the therapeutic effectiveness of chlorhexidine mouthrinse on gingival inflammation and subgingival microbiota in addition to daily mechanical plaque control in a population with established gingivitis.
Read the detailed description
Failure to perform oral hygiene adequately at the gingival margin results in the formation of a pathogenic plaque that has the potential to initiate gingivitis and in some individuals to progress to periodontitis. However, factors, such as dexterity and motivation, can limit the effectiveness of daily self-performed oral hygiene. The use of a chemical plaque-inhibitory mouthrinse as an adjunct to toothbrushing may improve the oral health of individuals who are inadequate in mechanical plaque control in maintaining gingival health.
Chlorhexidine (CHX) has been effectively used in the treatment of gingival inflammation and can be considered as the gold standard for oral antiseptics.
The effectiveness of CHX in reducing the formation of dental plaque and preventing gingivitis in addition to professional mechanical debridement were studied in several clinical studies, but there is limited number of studies investigating the effects of CHX on untreated gingivitis and subgingival microbiota.
- Conditions
- This Study Evaluated the Effectiveness of Chlorhexidine Mouthrinse on Subgingival Microbiota
- Being tested
- Chlorhexidine gluconate, Placebo mouthrinse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconateDrug
Placebo mouthrinseDrug
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine | Experimental | Not described Receives: Drug: Chlorhexidine gluconate |
| Placebo mouthrinse | Placebo comparator | Not described Receives: Drug: Placebo mouthrinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of chlorhexidine mouthrinse on gingival inflammation and subgingival microbiota in addition to daily mechanical plaque control
effectiveness of chlorhexidine mouthrinse subgingival microbiota in addition to daily mechanical plaque control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startMar 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for This Study Evaluated the Effectiveness of Chlorhexidine Mouthrinse on Subgingival MicrobiotaStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213550
- Sponsor's protocol ID
- 07-DIS-27
- Status last verified
- Oct 2010
- First submitted
- 1 Oct 2010
- Last updated
- 4 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Turkoglu O, Becerik S, Emingil G, Kutukculer N, Baylas H, Atilla G. The effect of adjunctive chlorhexidine mouthrinse on clinical parameters and gingival crevicular fluid cytokine levels in untreated plaque-associated gingivitis. Inflamm Res. 2009 May;58(5):277-83. doi: 10.1007/s00011-008-8129-z.
PubMed 19184351
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Chlorhexidine Mouthrinse On Peridontopathogens: A Randomized, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT01213550
- Acronym / sponsor ID
- 07-DIS-27
- Conditions
- This Study Evaluated the Effectiveness of Chlorhexidine Mouthrinse on Subgingival Microbiota
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 4 Oct 2010 (estimated)
- 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.
The aim of this study is to evaluate the therapeutic effectiveness of chlorhexidine mouthrinse on gingival inflammation and subgingival microbiota in addition to daily mechanical plaque control in a population with established gingivitis.
Detailed description
Failure to perform oral hygiene adequately at the gingival margin results in the formation of a pathogenic plaque that has the potential to initiate gingivitis and in some individuals to progress to periodontitis. However, factors, such as dexterity and motivation, can limit the effectiveness of daily self-performed oral hygiene. The use of a chemical plaque-inhibitory mouthrinse as an adjunct to toothbrushing may improve the oral health of individuals who are inadequate in mechanical plaque control in maintaining gingival health.
Chlorhexidine (CHX) has been effectively used in the treatment of gingival inflammation and can be considered as the gold standard for oral antiseptics.
The effectiveness of CHX in reducing the formation of dental plaque and preventing gingivitis in addition to professional mechanical debridement were studied in several clinical studies, but there is limited number of studies investigating the effects of CHX on untreated gingivitis and subgingival microbiota.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine | Experimental | Drug: Chlorhexidine gluconate |
| Placebo mouthrinse | Placebo comparator | Drug: Placebo mouthrinse |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-45 years old male or female with gingivitis associated with dental plaque, no clinical signs of destructive periodontal disease, clinical attachment loss < 3mm, a minimum of 20 teeth (teeth that have gross caries, were fully crowned or extensively restored, orthodontic banded, abutments, or third molars were not included in the tooth count).
Key exclusion criteria (1 listed)
- use of tobacco products, history or current manifestation of systemic disease which could impair immune response such as diabetes mellitus, immunological disorders, hepatitis and HIV infections, use of antibiotic or anti-inflammatory or immunosuppressive drugs during 3 months period prior to the start of the trial, periodontal therapy during the last 3 month, pregnancy or lactation and oral contraceptives usage.
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 gluconate | Drug | Chlorhexidine |
| Placebo mouthrinse | Drug | Placebo mouthrinse |
Primary outcome
effectiveness of chlorhexidine mouthrinse on gingival inflammation and subgingival microbiota in addition to daily mechanical plaque control
effectiveness of chlorhexidine mouthrinse subgingival microbiota in addition to daily mechanical plaque control
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2010.
- Results publication: PubMed 19184351Turkoglu O, Becerik S, Emingil G, Kutukculer N, Baylas H, Atilla G. The effect of adjunctive chlorhexidine mouthrinse on clinical parameters and gingival crevicular fluid cytokine levels in untreated plaque-associated gingivitis. Inflamm Res. 2009 May;58(5):277-83. doi: 10.1007/s00011-008-8129-z.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 gluconate in people with This Study Evaluated the Effectiveness of Chlorhexidine Mouthrinse on Subgingival Microbiota, run by Ege University at 2 sites in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 4 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of chlorhexidine mouthrinse on gingival inflammation and subgingival microbiota in addition to daily mechanical plaque control. 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?
On the ClinicalTrials.gov record for NCT01213550, which also lists 1 linked publication.
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 4 Oct 2010.