Staining Effect of ChlorhexidinePhase 2NCT02132546
Spectrophotometric Evaluation of Chlorhexidine Pigmentations After Oral Surgery: a Prospective Randomized Clinical Trial
A Phase 2 study testing Chlorhexidine in people with Staining Effect of Chlorhexidine, run by dott. Lorenzo Bevilacqua at 1 site in Italy.
Trial summary
The aim of this clinical trial was to evaluate through a clinical spectrophotometric analysis the staining side effect of a 0.2% CHX mouthwash containing an anti discoloration system (ADS) compared with a 0.12% and a 0.2% CHX alone mouthwash after periodontal surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Staining Effect of Chlorhexidine
- What is being tested?
- Chlorhexidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2011to Sep 2012
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Good general health conditions without a medical history of medication that might interfere with periodontal tissues
- Good plaque control (FMPS ≤ 25%) and low levels of infection (FMBS ≤ 25%)
- Need for periodontal surgery
Who cannot join
- Smokers
- Allergy to CHX
- Lack of written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spectrophotometric Evaluation of Chlorhexidine Pigmentations After Periodontal Flap Surgery: a Prospective Randomized Clinical Trial
The aim of this clinical trial was to evaluate through a clinical spectrophotometric analysis the staining side effect of a 0.2% CHX mouthwash containing an anti discoloration system (ADS) compared with a 0.12% and a 0.2% CHX alone mouthwash after periodontal surgery. The efficacy of the products and the patient's opinion and acceptance were also assessed.
- Conditions
- Staining Effect of Chlorhexidine
- Being tested
- Chlorhexidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDrug
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine 0,2% | Experimental | After surgery, the patient was given instruction following the post-operative protocol. Oral hygiene with toothbrush and dental floss was suspended only in the area that underwent periodontal surgery and the patient was given an anonymous bottle of mouthwash. According to random assignment (random generator, www.random.org), the bottle contained 0.2% CHX. Receives: Drug: Chlorhexidine |
| Chlorhexidine 0,2% with ADS | Experimental | After surgery, the patient was given instruction following the post-operative protocol. Oral hygiene with toothbrush and dental floss was suspended only in the area that underwent periodontal surgery and the patient was given an anonymous bottle of mouthwash. According to random assignment (random generator, www.random.org), the bottle contained 0.2% CHX with ADS. Receives: Drug: Chlorhexidine |
| Chlorhexidine 0,12% | Experimental | After surgery, the patient was given instruction following the post-operative protocol. Oral hygiene with toothbrush and dental floss was suspended only in the area that underwent periodontal surgery and the patient was given an anonymous bottle of mouthwash. According to random assignment (random generator, www.random.org), the bottle contained 0.12% CHX. Receives: Drug: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ΔE before and after the use of chlorhexidine
Change in ΔE before and after the use of chlorhexidine (ΔE is a measurement used to indicate how much a color deviates from an accepted standard. Perfect color has a ΔE of zero.)
Measured: Change from Baseline of ΔE after the use of chlorhexidine mouthrinses; change from Baseline of ΔE after the use of chlorhexidine mouthrinses at 1 week; change from Baseline of ΔE after the use of chlorhexidine mouthrinses at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startFeb 2011
- Primary completionOct 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staining Effect of ChlorhexidineStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- dott. Lorenzo Bevilacqua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dott. Lorenzo Bevilacqua, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132546
- Sponsor's protocol ID
- AAA-0001-TS
- Status last verified
- Apr 2014
- First submitted
- 30 Apr 2014
- Last updated
- 7 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectrophotometric Evaluation of Chlorhexidine Pigmentations After Periodontal Flap Surgery: a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02132546
- Acronym / sponsor ID
- AAA-0001-TS
- Conditions
- Staining Effect of Chlorhexidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- dott. Lorenzo BevilacquaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 7 May 2014 (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 clinical trial was to evaluate through a clinical spectrophotometric analysis the staining side effect of a 0.2% CHX mouthwash containing an anti discoloration system (ADS) compared with a 0.12% and a 0.2% CHX alone mouthwash after periodontal surgery. The efficacy of the products and the patient's opinion and acceptance were also assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine 0,2% | Experimental | Drug: ChlorhexidineAfter surgery, the patient was given instruction following the post-operative protocol. Oral hygiene with toothbrush and dental floss was suspended only in the area that underwent periodontal surgery and the patient was given an anonymous bottle of mouthwash. According to random assignment (random generator, www.random.org), the bottle contained 0.2% CHX. |
| Chlorhexidine 0,2% with ADS | Experimental | Drug: ChlorhexidineAfter surgery, the patient was given instruction following the post-operative protocol. Oral hygiene with toothbrush and dental floss was suspended only in the area that underwent periodontal surgery and the patient was given an anonymous bottle of mouthwash. According to random assignment (random generator, www.random.org), the bottle contained 0.2% CHX with ADS. |
| Chlorhexidine 0,12% | Experimental | Drug: ChlorhexidineAfter surgery, the patient was given instruction following the post-operative protocol. Oral hygiene with toothbrush and dental floss was suspended only in the area that underwent periodontal surgery and the patient was given an anonymous bottle of mouthwash. According to random assignment (random generator, www.random.org), the bottle contained 0.12% CHX. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Good general health conditions without a medical history of medication that might interfere with periodontal tissues
- Good plaque control (FMPS ≤ 25%) and low levels of infection (FMBS ≤ 25%)
- Need for periodontal surgery
Key exclusion criteria (3 listed)
- Smokers
- Allergy to CHX
- Lack of written informed consent
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 | Drug | Chlorhexidine 0,12%, Chlorhexidine 0,2%, Chlorhexidine 0,2% with ADS |
Primary outcome
Change in ΔE before and after the use of chlorhexidine
Time frame: Change from Baseline of ΔE after the use of chlorhexidine mouthrinses; change from Baseline of ΔE after the use of chlorhexidine mouthrinses at 1 week; change from Baseline of ΔE after the use of chlorhexidine mouthrinses at 2 weeks
Change in ΔE before and after the use of chlorhexidine (ΔE is a measurement used to indicate how much a color deviates from an accepted standard. Perfect color has a ΔE of zero.)
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 7 May 2014.
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 Phase 2 study testing Chlorhexidine in people with Staining Effect of Chlorhexidine, run by dott. Lorenzo Bevilacqua at 1 site in Italy.
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 3 inclusion and 3 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 7 May 2014. 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 Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in ΔE before and after the use of chlorhexidine (time frame: Change from Baseline of ΔE after the use of chlorhexidine mouthrinses; change from Baseline of ΔE after the use of chlorhexidine mouthrinses at 1 week; change from Baseline of ΔE after the use of chlorhexidine mouthrinses at 2 weeks). 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 7 May 2014.