Age ProblemNCT04658225
Gingivitis Treated With Chlorhexidine 0.12% Mouthwash in Young Adults
A study testing 0.12% chlorhexidine in people with Age Problem, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
The aim of this study will evaluate the effectiveness of 0.12% chlorhexidine solution as an anti-inflammatory agent and reducing the presence of biofilm in young adults. Read more about this study
- Who is it for?
- Ages 30 to 30 days
- Conditions the study is for
- Age Problem
- What is being tested?
- 0.12% chlorhexidine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2018to 1 Dec 2020
- Phase
- Interventional
- 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 30 to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presence of gingivitis
- Probing depth (PD) with maximum 3 mm
- Minimum of 20 teeth
- Age between 18 and 30 years old
Who cannot join
- Patients with periodontal disease (PD ≥ 4mm with clinical attachment loss)
- Diabetes
- Osteoporosis
- Pregnant or lactating females
- Smokers
- Users of immune suppressive medication
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- Phenytoin or cyclosporine
- Calcium channel blockers
- Antibiotics
- Nonsteroidal anti-inflammatory drugs
- HIV+ or AIDS
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal Fluminense
Nova Friburgo, Rio de Janeiro, 28625650
About this study
The aim of this study will evaluate the effectiveness of 0.12% chlorhexidine solution as an anti-inflammatory agent and reducing the presence of biofilm in young adults.
Read the detailed description
Thirty patients with gingivitis ages 18 to 30 year with a probing depth of at most 3 mm and at least 20 teeth will be selected and evaluate at baseline and after 4 weeks.
- Conditions
- Age Problem
- Being tested
- 0.12% chlorhexidine
- Keywords
- Gingivitis, Periodontal treatment
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.12% chlorhexidineProcedure or surgery
Also called Saline Solution
the patients were randomly allocated into two groups of 15 individuals to rinse with antimicrobials twice a day for a period of four weeks. Group A, received 0.12% chlorhexidine antimicrobian in a vial previously identified as solution 1 and group B, received saline solution identified as solution 2.
| Study group | Role | What they receive |
|---|---|---|
| Solution 1 | Active comparator | 0.12% chlorhexidine Receives: Procedure: 0.12% chlorhexidine |
| Solution 2 | Placebo comparator | Saline solution Receives: Procedure: 0.12% chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index
Check the biofilm as Ainano \& Bay 1975 index, Higher levels means worse.
Measured: 30 days
Secondary outcomes (1)
Gingival Index
Check the biofilm as Ainano \& Bay 1975 index, Higher levels means worse.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Aug 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age ProblemStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Thirty patients with gingivitis ages18 to 30 year with a probing depth of at most 3 mm and at least 20 teeth will select and evaluate at baseline and after 4 weeks. The periodontal clinical parameters will verify: plaque index (PI), gingival index (GI) and Simplified Oral Hygiene Index (OHIS). After evaluation of the clinical parameters, the patients will randomly allocated into two groups of 15 individuals to rinse with antimicrobials twice a day for a period of four weeks. Group A, received 0.12% chlorhexidine antimicrobian in a vial previously identified as solution 1 and group B, received saline solution identified as solution 2.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Alessandra da Cruz Galhardo Camargo, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658225
- Sponsor's protocol ID
- CAAE: 69912817.0.0000.5626.
- Status last verified
- Dec 2020
- First submitted
- 1 Dec 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingivitis Treated With Chlorhexidine 0.12% Mouthwash in Young Adults
- ClinicalTrials.gov ID
- NCT04658225
- Acronym / sponsor ID
- CAAE: 69912817.0.0000.5626.
- Conditions
- Age Problem
- Keywords
- Gingivitis, Periodontal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 8 Dec 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.
The aim of this study will evaluate the effectiveness of 0.12% chlorhexidine solution as an anti-inflammatory agent and reducing the presence of biofilm in young adults.
Detailed description
Thirty patients with gingivitis ages 18 to 30 year with a probing depth of at most 3 mm and at least 20 teeth will be selected and evaluate at baseline and after 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Thirty patients with gingivitis ages18 to 30 year with a probing depth of at most 3 mm and at least 20 teeth will select and evaluate at baseline and after 4 weeks. The periodontal clinical parameters will verify: plaque index (PI), gingival index (GI) and Simplified Oral Hygiene Index (OHIS). After evaluation of the clinical parameters, the patients will randomly allocated into two groups of 15 individuals to rinse with antimicrobials twice a day for a period of four weeks. Group A, received 0.12% chlorhexidine antimicrobian in a vial previously identified as solution 1 and group B, received saline solution identified as solution 2.
| Arm | Type | Receives |
|---|---|---|
| Solution 1 | Active comparator | Procedure: 0.12% chlorhexidine0.12% chlorhexidine |
| Solution 2 | Placebo comparator | Procedure: 0.12% chlorhexidineSaline solution |
Who may qualify
- Ages
- 30 to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Presence of gingivitis
- Probing depth (PD) with maximum 3 mm
- Minimum of 20 teeth
- Age between 18 and 30 years old
Key exclusion criteria (11 listed)
- Patients with periodontal disease (PD ≥ 4mm with clinical attachment loss)
- Diabetes
- Osteoporosis
- Pregnant or lactating females
- Smokers
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 |
|---|---|---|
| 0.12% chlorhexidineAlso: Saline Solutionthe patients were randomly allocated into two groups of 15 individuals to rinse with antimicrobials twice a day for a period of four weeks. Group A, received 0.12% chlorhexidine antimicrobian in a vial previously identified as solution 1 and group B, received saline solution identified as solution 2. | Procedure or surgery | Solution 1, Solution 2 |
Primary outcome
Plaque Index
Time frame: 30 days
Check the biofilm as Ainano \& Bay 1975 index, Higher levels means worse.
1 secondary outcome
Gingival Index
Time frame: 30 days
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 11 Dec 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.12% chlorhexidine in people with Age Problem, run by Universidade Federal Fluminense at 1 site in Brazil.
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 4 inclusion and 11 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 11 Dec 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 Brazil. 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.
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?
Plaque Index (time frame: 30 days). 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 11 Dec 2020.