Adverse EffectCHX+ADSNCT02709824
Anti-staining Efficacy of Anti-Discoloration System (ADS) Added to Chlorhexidine (CHX)
A study testing Chlorhexidine gluconate with ADS and Chlorhexidine gluconate without ADS in people with Adverse Effect, run by University of Milan at 1 site in Italy.
Trial summary
Dental staining is the most common local side effect of chlorhexidine (CHX) mouthwashes. A prospective, cross-over, randomized clinical trial will be carried out in triple blind to compare the effect on dental staining of two 0.12% CHX mouthwashes: with or without anti-discoloration system (ADS). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Effect
- What is being tested?
- Chlorhexidine gluconate with ADS and Chlorhexidine gluconate without ADS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2011to Jul 2012
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- to be free from oral mucosa conditions affecting its integrity
- to avoid drug or mouthwash intake during the study and in the previous month
Who cannot join
- specific allergy to mouthrinses
- presence of periodontitis
- frequent use of Chlorhexidine-based oral hygiene products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Anti-Discoloration System (ADS) to Reduce Dental Staining in a 0.12% Chlorhexidine-based Mouthwash
Dental staining is the most common local side effect of chlorhexidine (CHX) mouthwashes.
A prospective, cross-over, randomized clinical trial will be carried out in triple blind to compare the effect on dental staining of two 0.12% CHX mouthwashes: with or without anti-discoloration system (ADS). Twenty-two healthy subjects will be enrolled. Briefly, the study includes two sequential stages: in the first phase, the "immediate" objective and subjective evaluation of dental discoloration by spectroscopic and questionnaire-based analyses will be recorded, at baselines and after each 21-days-long cycle of mouthwash. A wash-out period between the cycles of 21 days will be performed.
In the second phase, a long-term (after 6 months) subjective evaluation of dental discoloration will be obtained by means of clinical photograph visual analysis and new questionnaires.
Read the detailed description
In the first phase, the "immediate" objective and subjective evaluation of dental discoloration by spectroscopic (CIE L*a*b* data analysis with DeltaE evaluation) and questionnaire-based analyses will be recorded. Immediate visual analysis of tooth pigmentation will be evaluated by volunteer him/herself, using a mirror, and by a single dentist soon after the end of each treatment. Participants will indicate the presence/absence of dental pigmentation, and to quantify it with a numeric scale (0= no pigmentation to 10= very strong pigmentation).
These analyses will be performed at baselines and after each 21-days-long cycle of mouthwash.
A wash-out period between the cycles of 21 days will be performed. In the second "late" phase, a long-term subjective evaluation of dental discoloration will be obtained by means of the visual analysis of clinical photograph and new questionnaires. After 6 months from clinical trial (second stage of the study), frontal dental images of volunteers, collected during the first phase, will be printed on photographic paper and, then, visually analyzed, in blind, by the 22 volunteers themselves, as well as by 14 dentists and 13 oral hygienists ad hoc recruited. Dentists and oral hygienists, in particular, will be asked to observe two images of all the 22 subjects, i.e. after treatment with A or B mouthwash, and to answer to the question: "Which picture shows the most pigmented teeth?" Possible answers will be: "A, or B or no difference between the two images". Pigmentation will be also quantified using the numeric scale (0= no pigmentation to 10=strong pigmentation).
The observer will be not instructed in how the color of the teeth should appear in case of CHX pigmentation.
- Conditions
- Adverse Effect
- Being tested
- Chlorhexidine gluconate with ADS, Chlorhexidine gluconate without ADS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconate with ADSDrug
Also called Curasept (0.12% Chlorhexidine gluconate with ADS)
Oral rinsing, twice a day, for 21 days
Chlorhexidine gluconate without ADSDrug
Also called Dentosan (0.12% Chlorhexidine gluconate without ADS)
Oral rinsing, twice a day, for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine gluconate with ADS | Active comparator | Chlorhexidine 0.12% plus Anti-Discoloration System Mouthwash Receives: Drug: Chlorhexidine gluconate with ADS |
| Chlorhexidine gluconate without ADS | Active comparator | Chlorhexidine 0.12% Mouthwash Receives: Drug: Chlorhexidine gluconate without ADS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Staining - spectroscopic evaluation
dental color before and after the two treatments
Measured: 21 days
Secondary outcomes (2)
Dental Staining - visual evaluation
dental color before and after the two treatments
Measured: 21 days
Dental Staining - visual evaluation on images
dental color before and after the two treatments
Measured: 21 days of treatments, re-analysis of images after 6 months from the end of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startDec 2011
- Primary completionFeb 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adverse EffectStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANDREA SARDELLA, University of Milan
- Investigators
- Antonio Carrassi, MD, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709824
- Sponsor's protocol ID
- ADS2012
- Acronym
- CHX+ADS
- Status last verified
- Mar 2016
- First submitted
- 11 Mar 2016
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cortellini P, Labriola A, Zambelli R, Prato GP, Nieri M, Tonetti MS. Chlorhexidine with an anti discoloration system after periodontal flap surgery: a cross-over, randomized, triple-blind clinical trial. J Clin Periodontol. 2008 Jul;35(7):614-20. doi: 10.1111/j.1600-051X.2008.01238.x. Epub 2008 Apr 16.
PubMed 18422695Bernardi F, Pincelli MR, Carloni S, Gatto MR, Montebugnoli L. Chlorhexidine with an Anti Discoloration System. A comparative study. Int J Dent Hyg. 2004 Aug;2(3):122-6. doi: 10.1111/j.1601-5037.2004.00083.x.
PubMed 16451475Solis C, Santos A, Nart J, Violant D. 0.2% chlorhexidine mouthwash with an antidiscoloration system versus 0.2% chlorhexidine mouthwash: a prospective clinical comparative study. J Periodontol. 2011 Jan;82(1):80-5. doi: 10.1902/jop.2010.100289. Epub 2010 Jul 27.
PubMed 20653433Li W, Wang RE, Finger M, Lang NP. Evaluation of the antigingivitis effect of a chlorhexidine mouthwash with or without an antidiscoloration system compared to placebo during experimental gingivitis. J Investig Clin Dent. 2014 Feb;5(1):15-22. doi: 10.1111/jicd.12050. Epub 2013 Jun 14.
PubMed 23766285
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Anti-Discoloration System (ADS) to Reduce Dental Staining in a 0.12% Chlorhexidine-based Mouthwash
- ClinicalTrials.gov ID
- NCT02709824
- Acronym / sponsor ID
- CHX+ADS / ADS2012
- Conditions
- Adverse Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Mar 2016 (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.
Dental staining is the most common local side effect of chlorhexidine (CHX) mouthwashes.
A prospective, cross-over, randomized clinical trial will be carried out in triple blind to compare the effect on dental staining of two 0.12% CHX mouthwashes: with or without anti-discoloration system (ADS). Twenty-two healthy subjects will be enrolled. Briefly, the study includes two sequential stages: in the first phase, the "immediate" objective and subjective evaluation of dental discoloration by spectroscopic and questionnaire-based analyses will be recorded, at baselines and after each 21-days-long cycle of mouthwash. A wash-out period between the cycles of 21 days will be performed.
In the second phase, a long-term (after 6 months) subjective evaluation of dental discoloration will be obtained by means of clinical photograph visual analysis and new questionnaires.
Detailed description
In the first phase, the "immediate" objective and subjective evaluation of dental discoloration by spectroscopic (CIE L*a*b* data analysis with DeltaE evaluation) and questionnaire-based analyses will be recorded. Immediate visual analysis of tooth pigmentation will be evaluated by volunteer him/herself, using a mirror, and by a single dentist soon after the end of each treatment. Participants will indicate the presence/absence of dental pigmentation, and to quantify it with a numeric scale (0= no pigmentation to 10= very strong pigmentation).
These analyses will be performed at baselines and after each 21-days-long cycle of mouthwash.
A wash-out period between the cycles of 21 days will be performed. In the second "late" phase, a long-term subjective evaluation of dental discoloration will be obtained by means of the visual analysis of clinical photograph and new questionnaires. After 6 months from clinical trial (second stage of the study), frontal dental images of volunteers, collected during the first phase, will be printed on photographic paper and, then, visually analyzed, in blind, by the 22 volunteers themselves, as well as by 14 dentists and 13 oral hygienists ad hoc recruited. Dentists and oral hygienists, in particular, will be asked to observe two images of all the 22 subjects, i.e. after treatment with A or B mouthwash, and to answer to the question: "Which picture shows the most pigmented teeth?" Possible answers will be: "A, or B or no difference between the two images". Pigmentation will be also quantified using the numeric scale (0= no pigmentation to 10=strong pigmentation).
The observer will be not instructed in how the color of the teeth should appear in case of CHX pigmentation.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine gluconate with ADS | Active comparator | Drug: Chlorhexidine gluconate with ADSChlorhexidine 0.12% plus Anti-Discoloration System Mouthwash |
| Chlorhexidine gluconate without ADS | Active comparator | Drug: Chlorhexidine gluconate without ADSChlorhexidine 0.12% Mouthwash |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- to be free from oral mucosa conditions affecting its integrity
- to avoid drug or mouthwash intake during the study and in the previous month
Key exclusion criteria (3 listed)
- specific allergy to mouthrinses
- presence of periodontitis
- frequent use of Chlorhexidine-based oral hygiene products
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 with ADSAlso: Curasept (0.12% Chlorhexidine gluconate with ADS)Oral rinsing, twice a day, for 21 days | Drug | Chlorhexidine gluconate with ADS |
| Chlorhexidine gluconate without ADSAlso: Dentosan (0.12% Chlorhexidine gluconate without ADS)Oral rinsing, twice a day, for 21 days | Drug | Chlorhexidine gluconate without ADS |
Primary outcome
Dental Staining - spectroscopic evaluation
Time frame: 21 days
dental color before and after the two treatments
2 secondary outcomes
Dental Staining - visual evaluation
Time frame: 21 days
Dental Staining - visual evaluation on images
Time frame: 21 days of treatments, re-analysis of images after 6 months from the end of the trial
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 22 Mar 2016.
- Background: PubMed 18422695Cortellini P, Labriola A, Zambelli R, Prato GP, Nieri M, Tonetti MS. Chlorhexidine with an anti discoloration system after periodontal flap surgery: a cross-over, randomized, triple-blind clinical trial. J Clin Periodontol. 2008 Jul;35(7):614-20. doi: 10.1111/j.1600-051X.2008.01238.x. Epub 2008 Apr 16.
- Background: PubMed 16451475Bernardi F, Pincelli MR, Carloni S, Gatto MR, Montebugnoli L. Chlorhexidine with an Anti Discoloration System. A comparative study. Int J Dent Hyg. 2004 Aug;2(3):122-6. doi: 10.1111/j.1601-5037.2004.00083.x.
- Background: PubMed 20653433Solis C, Santos A, Nart J, Violant D. 0.2% chlorhexidine mouthwash with an antidiscoloration system versus 0.2% chlorhexidine mouthwash: a prospective clinical comparative study. J Periodontol. 2011 Jan;82(1):80-5. doi: 10.1902/jop.2010.100289. Epub 2010 Jul 27.
- Background: PubMed 23766285Li W, Wang RE, Finger M, Lang NP. Evaluation of the antigingivitis effect of a chlorhexidine mouthwash with or without an antidiscoloration system compared to placebo during experimental gingivitis. J Investig Clin Dent. 2014 Feb;5(1):15-22. doi: 10.1111/jicd.12050. Epub 2013 Jun 14.
- 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.
Antonio Carrassi, MD principal investigator
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine gluconate with ADS and Chlorhexidine gluconate without ADS in people with Adverse Effect, run by University of Milan 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 2 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 22 Mar 2016. 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.
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?
Dental Staining - spectroscopic evaluation (time frame: 21 days). 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 NCT02709824, which also lists 4 linked publications.
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 22 Mar 2016.