Chronic PeriodontitisPhase 3NCT02875769
Pre-procedural Mouthwash in Reducing Bacteria in Dental Aerosols
A Phase 3 study testing Dental prophylaxis, Mouthwash CPC+Zn+F and Mouthwash CHX in people with Chronic Periodontitis, run by University of Guarulhos.
Trial summary
The aim of this randomized, single blinded clinical trial was to evaluate the effect of a pre-procedural mouthwash containing cetylpyridinium chloride (CPC), zinc lactate (Zn) and sodium fluoride (F) in the reduction of viable bacteria in oral aerosol/splatter after a dental prophylaxis with ultrasonic scaler. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Dental prophylaxis, Mouthwash CPC+Zn+F and Mouthwash CHX
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Apr 2015
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 18-70 years;
- minimum of 20 natural teeth (excluding third molars and teeth with advanced decay indicated for extraction);
- at least 80% of the sites with visible supragingival plaque;
- fewer than 10% of sites with visible supragingival calculus;
- fewer than 30% of sites with probing depth (PD) ≥ 5 mm.
Who cannot join
- presence of orthodontic bands;
- partial removable dentures;
- lesions of the soft or hard tissues of the oral cavity;
- carious lesions requiring immediate restorative treatment;
- history of allergy to CHX, CPC, zinc lactate or sodium fluoride;
- participation in any other clinical study within the one-month period prior to entering into the study;
Show all 11Show fewer
- professional tooth cleaning procedure (oral prophylaxis) during the period of one month prior to entering the study;
- pregnant or breast-feeding women;
- antibiotic therapy in the previous 6 months;
- continuous use of oral mouthwashes;
- any systemic condition that may require prophylactic medication for dental treatment (e.g., mitral valve prolapse).
About this study
Official title: Effectiveness of a Pre-procedural Mouthwash in Reducing Bacteria in Dental Aerosols and Splatters: a Randomized Clinical Trial
The aim of this randomized, single blinded clinical trial was to evaluate the effect of a pre-procedural mouthwash containing cetylpyridinium chloride (CPC), zinc lactate (Zn) and sodium fluoride (F) in the reduction of viable bacteria in oral aerosol/splatter after a dental prophylaxis with ultrasonic scaler.
Read the detailed description
The propagation of oral microorganisms in the dental office during different oral procedures has been a concern. The use of certain equipment such as ultrasonic devices, highspeed dental handpieces or three-way syringes may spread aerosols and splatters containing microorganisms in the environment. These microorganisms may cause cross-infections in the dental office, jeopardizing the health of patients and dental professionals. Different procedures, materials and antimicrobial agents have been proposed to minimize microbial cross-contamination in the dental office. Chlorhexidine (CHX) is considered the gold standard substance in controlling oral biofilm growth in the oral cavity or microbial spread by oral aerosols due to its broad antibacterial spectrum and substantivity of 8 to 12 hours. However, other antiseptics have also been used as pre-procedural mouthwashes. CPC has an important antimicrobial activity and is considered a safe product for marketing. In this context, the present trend has been to combine more than one active substance in mouthwash and toothpaste formulations with the aim of increasing the efficacy of the products, or treating more than one clinical problem, such as plaque accumulation and halitosis, caries or gingival inflammation. Therefore, the aim of this randomized clinical trial (RCT) was to evaluate the effectiveness of a new mouthwash formulation containing 0.075% CPC, 0.28% zinc lactate and 0.05% sodium fluoride (CPC+Zn+F) in reducing viable bacteria present in oral aerosol/splatter. Sixty systemically healthy volunteers receiving dental prophylaxis were randomly assigned to one of the following experimental groups (15 per group): i) rinsing with 0.075% CPC, 0.28% Zn and 0.05% F (CPC+Zn+F), ii) 0.12% chlorhexidine digluconate (CHX), iii) no rinsing and iv) rinsing with water. Viable bacteria were collected from different locations in the dental office on enriched TSA plates and anaerobically incubated for 72 hours. The colonies were counted and species were then identified by Checkerboard DNA-DNA Hybridization. The total number of colony-forming units (CFUs) detected in the aerosols/splatters from volunteers who rinsed with CPC+Zn+F or CHX was statistically significantly (p<0.05) lower than of those subjects who did not rinse or who rinsed with water. When all locations were considered together, the aerosols/splatters from the CPC+Zn+F and CHX groups showed, respectively, 70% and 77% fewer CFUs than those from the no rinsing group and 61% and 70% than those from the water group. The mean proportions of bacterial species from the orange complex were statistically significantly (p<0.05) lower in aerosols/splatter from the CPC+Zn+F and CHX groups compared with the two negative controls. In conclusion, the results of the present investigation showed that a mouthwash containing 0.075% CPC, 0.28% Zn and 0.05% F, is effective in reducing viable bacteria in oral aerosol/splatter after a dental prophylaxis with ultrasonic scaler. This finding is highly relevant to the clinical practice, as it may greatly reduce the risk of cross-contamination in dental offices.
- Conditions
- Chronic Periodontitis
- Being tested
- Dental prophylaxis, Mouthwash CPC+Zn+F, Mouthwash CHX, No rinsing, Water
- Keywords
- cetylpyridinium chloride, chlorhexidine, oral aerosol, oral splatter, mouthwash, microbiology
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental prophylaxisProcedure or surgery
Full mouth dental prophylaxis (FMDP) was conducted in one appointment lasting 10 minute, using an ultrasonic scaler at a frequency of 25 kHz (Cavitron Select SPC, Dentsply professional, York, PA, USA) at less than 50% power. The FMDP performed without anesthesia and in order to eliminate supragingival plaque, calculus and stainings.
Mouthwash CPC+Zn+FDrug
Also called Pre-procedural mouthwash CPC+Zn+F
The volunteer rinsed with pre-procedural mouthwash containing 0.075% cetylpyridinium chloride, 0.28% zinc lactate and 0.05% sodium fluoride in an Alcohol-free base for one minute, 20 ml of solution and then expectorated all remaining liquid.
Mouthwash CHXDrug
Also called Pre-procedural mouthwash
The volunteer rinsed with pre-procedural mouthwash containing 0.12% CHX with 10% alcohol for one minute, 20 ml of solution and then expectorated all remaining liquid.
No rinsingOther
The volunteer did not rinse with any pre-procedural mothwash.
WaterOther
The volunteer rinsed with pre-procedural mouthwash containing water from a three-way syringe for one minute, 20 ml of water and then expectorated all remaining liquid.
| Study group | Role | What they receive |
|---|---|---|
| Test: Mouthwash CPC+Zn+F | Experimental | To rinse with pre-procedural mouthwash containing 0.075% cetylpyridinium chloride, 0.28% zinc lactate and 0.05% sodium fluoride in an Alcohol-free base (for one minute and 20 ml of solution) + full mouth dental prophylaxis using ultrasonic scaler. Receives: Procedure: Dental prophylaxis; Drug: Mouthwash CPC+Zn+F |
| Positive control: Mouthwash CHX | Active comparator | To rinse with pre-procedural mouthwash containing 0.12% CHX with 10% alcohol (for one minute and 20 ml of solution) + full mouth dental prophylaxis using ultrasonic scaler. Receives: Procedure: Dental prophylaxis; Drug: Mouthwash CHX |
| Negative control A: No rinsing | Placebo comparator | No rinsing with pre-procedural mouthwash + full mouth dental prophylaxis using ultrasonic scaler. Receives: Procedure: Dental prophylaxis; Other: No rinsing |
| Negative control B: Water | Placebo comparator | To rinse with pre-procedural mouthwash containing water from a three-way syringe (for one minute and 20 ml of solution) + full mouth dental prophylaxis using ultrasonic scaler. Receives: Procedure: Dental prophylaxis; Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between groups (test, positive control, negative control A and negative control B) for the mean number of total colony-forming units (CFUs) in all plates.
Measured: During oral prophylaxis procedure.
Secondary outcomes (5)
Number of total CFUs in plates positioned on the clinician forehead.
Measured: During oral prophylaxis procedure.
Number of total CFUs in plates positioned on the volunteer's chest.
Measured: During oral prophylaxis procedure.
Number of total CFUs in plates positioned on the support board.
Measured: During oral prophylaxis procedure.
Proportion of the microbial complexes.
Measured: During oral prophylaxis procedure.
Reduction in CFUs in the CPC+Zn+F and CHX groups in comparison with the two negative control groups.
Measured: During oral prophylaxis procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startFeb 2015
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guarulhos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belén Retamal-Valdes, University of Guarulhos
- Investigators
- Magda Feres, Professor, Study chair, Guarulhos University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875769
- Sponsor's protocol ID
- CAAE: 41244315.4.0000.5506
- Status last verified
- Jun 2020
- First submitted
- 18 Aug 2016
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: September 2016
Publications
Bentley CD, Burkhart NW, Crawford JJ. Evaluating spatter and aerosol contamination during dental procedures. J Am Dent Assoc. 1994 May;125(5):579-84. doi: 10.14219/jada.archive.1994.0093.
PubMed 8195499Cochran MA, Miller CH, Sheldrake MA. The efficacy of the rubber dam as a barrier to the spread of microorganisms during dental treatment. J Am Dent Assoc. 1989 Jul;119(1):141-4. doi: 10.14219/jada.archive.1989.0131.
PubMed 2760346Erovic Ademovski S, Lingstrom P, Renvert S. The effect of different mouth rinse products on intra-oral halitosis. Int J Dent Hyg. 2016 May;14(2):117-23. doi: 10.1111/idh.12148. Epub 2015 May 31.
PubMed 26031397Grenier D. Quantitative analysis of bacterial aerosols in two different dental clinic environments. Appl Environ Microbiol. 1995 Aug;61(8):3165-8. doi: 10.1128/aem.61.8.3165-3168.1995.
PubMed 7487047Gupta G, Mitra D, Ashok KP, Gupta A, Soni S, Ahmed S, Arya A. Efficacy of preprocedural mouth rinsing in reducing aerosol contamination produced by ultrasonic scaler: a pilot study. J Periodontol. 2014 Apr;85(4):562-8. doi: 10.1902/jop.2013.120616. Epub 2013 Jul 15.
PubMed 23855840Harrel SK, Molinari J. Aerosols and splatter in dentistry: a brief review of the literature and infection control implications. J Am Dent Assoc. 2004 Apr;135(4):429-37. doi: 10.14219/jada.archive.2004.0207.
PubMed 15127864Jones CG. Chlorhexidine: is it still the gold standard? Periodontol 2000. 1997 Oct;15:55-62. doi: 10.1111/j.1600-0757.1997.tb00105.x.
PubMed 9643233Kanjirath PP, Coplen AE, Chapman JC, Peters MC, Inglehart MR. Effectiveness of gloves and infection control in dentistry: student and provider perspectives. J Dent Educ. 2009 May;73(5):571-80.
PubMed 19433532Keni NN, Aras MA, Chitre V. Chlorhexidine allergy due to topical application. Indian J Dent Res. 2012 Sep-Oct;23(5):674-6. doi: 10.4103/0970-9290.107393.
PubMed 23422617Kjaerheim V, Skaare A, Barkvoll P, Rolla G. Antiplaque, antibacterial, and anti-inflammatory properties of triclosan mouthrinses in combination with zinc citrate or polyvinylmethylether maleic acid (PVM-MA) copolymer. Eur J Oral Sci. 1996 Oct-Dec;104(5-6):529-34. doi: 10.1111/j.1600-0722.1996.tb00137.x.
PubMed 9021321Lang C, Murgia C, Leong M, Tan LW, Perozzi G, Knight D, Ruffin R, Zalewski P. Anti-inflammatory effects of zinc and alterations in zinc transporter mRNA in mouse models of allergic inflammation. Am J Physiol Lung Cell Mol Physiol. 2007 Feb;292(2):L577-84. doi: 10.1152/ajplung.00280.2006. Epub 2006 Nov 3.
PubMed 17085522Leggat PA, Kedjarune U. Bacterial aerosols in the dental clinic: a review. Int Dent J. 2001 Feb;51(1):39-44. doi: 10.1002/j.1875-595x.2001.tb00816.x.
PubMed 11326448Legnani P, Checchi L, Pelliccioni GA, D'Achille C. Atmospheric contamination during dental procedures. Quintessence Int. 1994 Jun;25(6):435-9.
PubMed 7938434Mendes L, Coimbra J, Pereira AL, Resende M, Pinto MG. Comparative effect of a new mouthrinse containing chlorhexidine, triclosan and zinc on volatile sulphur compounds: a randomized, crossover, double-blind study. Int J Dent Hyg. 2016 Aug;14(3):202-8. doi: 10.1111/idh.12132. Epub 2015 Feb 26.
PubMed 25727335Nejatidanesh F, Khosravi Z, Goroohi H, Badrian H, Savabi O. Risk of Contamination of Different Areas of Dentist's Face During Dental Practices. Int J Prev Med. 2013 May;4(5):611-5.
PubMed 23930175
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Pre-procedural Mouthwash in Reducing Bacteria in Dental Aerosols and Splatters: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02875769
- Acronym / sponsor ID
- CAAE: 41244315.4.0000.5506
- Conditions
- Chronic Periodontitis
- Keywords
- cetylpyridinium chloride, chlorhexidine, oral aerosol, oral splatter, mouthwash, microbiology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of GuarulhosUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Aug 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.
The aim of this randomized, single blinded clinical trial was to evaluate the effect of a pre-procedural mouthwash containing cetylpyridinium chloride (CPC), zinc lactate (Zn) and sodium fluoride (F) in the reduction of viable bacteria in oral aerosol/splatter after a dental prophylaxis with ultrasonic scaler.
Detailed description
The propagation of oral microorganisms in the dental office during different oral procedures has been a concern. The use of certain equipment such as ultrasonic devices, highspeed dental handpieces or three-way syringes may spread aerosols and splatters containing microorganisms in the environment. These microorganisms may cause cross-infections in the dental office, jeopardizing the health of patients and dental professionals. Different procedures, materials and antimicrobial agents have been proposed to minimize microbial cross-contamination in the dental office. Chlorhexidine (CHX) is considered the gold standard substance in controlling oral biofilm growth in the oral cavity or microbial spread by oral aerosols due to its broad antibacterial spectrum and substantivity of 8 to 12 hours. However, other antiseptics have also been used as pre-procedural mouthwashes. CPC has an important antimicrobial activity and is considered a safe product for marketing. In this context, the present trend has been to combine more than one active substance in mouthwash and toothpaste formulations with the aim of increasing the efficacy of the products, or treating more than one clinical problem, such as plaque accumulation and halitosis, caries or gingival inflammation. Therefore, the aim of this randomized clinical trial (RCT) was to evaluate the effectiveness of a new mouthwash formulation containing 0.075% CPC, 0.28% zinc lactate and 0.05% sodium fluoride (CPC+Zn+F) in reducing viable bacteria present in oral aerosol/splatter. Sixty systemically healthy volunteers receiving dental prophylaxis were randomly assigned to one of the following experimental groups (15 per group): i) rinsing with 0.075% CPC, 0.28% Zn and 0.05% F (CPC+Zn+F), ii) 0.12% chlorhexidine digluconate (CHX), iii) no rinsing and iv) rinsing with water. Viable bacteria were collected from different locations in the dental office on enriched TSA plates and anaerobically incubated for 72 hours. The colonies were counted and species were then identified by Checkerboard DNA-DNA Hybridization. The total number of colony-forming units (CFUs) detected in the aerosols/splatters from volunteers who rinsed with CPC+Zn+F or CHX was statistically significantly (p<0.05) lower than of those subjects who did not rinse or who rinsed with water. When all locations were considered together, the aerosols/splatters from the CPC+Zn+F and CHX groups showed, respectively, 70% and 77% fewer CFUs than those from the no rinsing group and 61% and 70% than those from the water group. The mean proportions of bacterial species from the orange complex were statistically significantly (p<0.05) lower in aerosols/splatter from the CPC+Zn+F and CHX groups compared with the two negative controls. In conclusion, the results of the present investigation showed that a mouthwash containing 0.075% CPC, 0.28% Zn and 0.05% F, is effective in reducing viable bacteria in oral aerosol/splatter after a dental prophylaxis with ultrasonic scaler. This finding is highly relevant to the clinical practice, as it may greatly reduce the risk of cross-contamination in dental offices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test: Mouthwash CPC+Zn+F | Experimental | Procedure: Dental prophylaxis, Drug: Mouthwash CPC+Zn+FTo rinse with pre-procedural mouthwash containing 0.075% cetylpyridinium chloride, 0.28% zinc lactate and 0.05% sodium fluoride in an Alcohol-free base (for one minute and 20 ml of solution) + full mouth dental prophylaxis using ultrasonic scaler. |
| Positive control: Mouthwash CHX | Active comparator | Procedure: Dental prophylaxis, Drug: Mouthwash CHXTo rinse with pre-procedural mouthwash containing 0.12% CHX with 10% alcohol (for one minute and 20 ml of solution) + full mouth dental prophylaxis using ultrasonic scaler. |
| Negative control A: No rinsing | Placebo comparator | Procedure: Dental prophylaxis, Other: No rinsingNo rinsing with pre-procedural mouthwash + full mouth dental prophylaxis using ultrasonic scaler. |
| Negative control B: Water | Placebo comparator | Procedure: Dental prophylaxis, Other: WaterTo rinse with pre-procedural mouthwash containing water from a three-way syringe (for one minute and 20 ml of solution) + full mouth dental prophylaxis using ultrasonic scaler. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged between 18-70 years;
- minimum of 20 natural teeth (excluding third molars and teeth with advanced decay indicated for extraction);
- at least 80% of the sites with visible supragingival plaque;
- fewer than 10% of sites with visible supragingival calculus;
- fewer than 30% of sites with probing depth (PD) ≥ 5 mm.
Key exclusion criteria (11 listed)
- presence of orthodontic bands;
- partial removable dentures;
- lesions of the soft or hard tissues of the oral cavity;
- carious lesions requiring immediate restorative treatment;
- history of allergy to CHX, CPC, zinc lactate or sodium fluoride;
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 |
|---|---|---|
| Dental prophylaxisFull mouth dental prophylaxis (FMDP) was conducted in one appointment lasting 10 minute, using an ultrasonic scaler at a frequency of 25 kHz (Cavitron Select SPC, Dentsply professional, York, PA, USA) at less than 50% power. The FMDP performed without anesthesia and in order to eliminate supragingival plaque, calculus and stainings. | Procedure or surgery | Negative control A: No rinsing, Negative control B: Water, Positive control: Mouthwash CHX, Test: Mouthwash CPC+Zn+F |
| Mouthwash CPC+Zn+FAlso: Pre-procedural mouthwash CPC+Zn+FThe volunteer rinsed with pre-procedural mouthwash containing 0.075% cetylpyridinium chloride, 0.28% zinc lactate and 0.05% sodium fluoride in an Alcohol-free base for one minute, 20 ml of solution and then expectorated all remaining liquid. | Drug | Test: Mouthwash CPC+Zn+F |
| Mouthwash CHXAlso: Pre-procedural mouthwashThe volunteer rinsed with pre-procedural mouthwash containing 0.12% CHX with 10% alcohol for one minute, 20 ml of solution and then expectorated all remaining liquid. | Drug | Positive control: Mouthwash CHX |
| No rinsingThe volunteer did not rinse with any pre-procedural mothwash. | Other | Negative control A: No rinsing |
| WaterThe volunteer rinsed with pre-procedural mouthwash containing water from a three-way syringe for one minute, 20 ml of water and then expectorated all remaining liquid. | Other | Negative control B: Water |
Primary outcome
Difference between groups (test, positive control, negative control A and negative control B) for the mean number of total colony-forming units (CFUs) in all plates.
Time frame: During oral prophylaxis procedure.
5 secondary outcomes
Number of total CFUs in plates positioned on the clinician forehead.
Time frame: During oral prophylaxis procedure.
Number of total CFUs in plates positioned on the volunteer's chest.
Time frame: During oral prophylaxis procedure.
Number of total CFUs in plates positioned on the support board.
Time frame: During oral prophylaxis procedure.
Proportion of the microbial complexes.
Time frame: During oral prophylaxis procedure.
Reduction in CFUs in the CPC+Zn+F and CHX groups in comparison with the two negative control groups.
Time frame: During oral prophylaxis procedure.
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 Jun 2020.
- Background: PubMed 8195499Bentley CD, Burkhart NW, Crawford JJ. Evaluating spatter and aerosol contamination during dental procedures. J Am Dent Assoc. 1994 May;125(5):579-84. doi: 10.14219/jada.archive.1994.0093.
- Background: PubMed 2760346Cochran MA, Miller CH, Sheldrake MA. The efficacy of the rubber dam as a barrier to the spread of microorganisms during dental treatment. J Am Dent Assoc. 1989 Jul;119(1):141-4. doi: 10.14219/jada.archive.1989.0131.
- Background: PubMed 26031397Erovic Ademovski S, Lingstrom P, Renvert S. The effect of different mouth rinse products on intra-oral halitosis. Int J Dent Hyg. 2016 May;14(2):117-23. doi: 10.1111/idh.12148. Epub 2015 May 31.
- Background: PubMed 7487047Grenier D. Quantitative analysis of bacterial aerosols in two different dental clinic environments. Appl Environ Microbiol. 1995 Aug;61(8):3165-8. doi: 10.1128/aem.61.8.3165-3168.1995.
- Background: PubMed 23855840Gupta G, Mitra D, Ashok KP, Gupta A, Soni S, Ahmed S, Arya A. Efficacy of preprocedural mouth rinsing in reducing aerosol contamination produced by ultrasonic scaler: a pilot study. J Periodontol. 2014 Apr;85(4):562-8. doi: 10.1902/jop.2013.120616. Epub 2013 Jul 15.
- Background: PubMed 15127864Harrel SK, Molinari J. Aerosols and splatter in dentistry: a brief review of the literature and infection control implications. J Am Dent Assoc. 2004 Apr;135(4):429-37. doi: 10.14219/jada.archive.2004.0207.
- Background: PubMed 9643233Jones CG. Chlorhexidine: is it still the gold standard? Periodontol 2000. 1997 Oct;15:55-62. doi: 10.1111/j.1600-0757.1997.tb00105.x.
- Background: PubMed 19433532Kanjirath PP, Coplen AE, Chapman JC, Peters MC, Inglehart MR. Effectiveness of gloves and infection control in dentistry: student and provider perspectives. J Dent Educ. 2009 May;73(5):571-80.
- Background: PubMed 23422617Keni NN, Aras MA, Chitre V. Chlorhexidine allergy due to topical application. Indian J Dent Res. 2012 Sep-Oct;23(5):674-6. doi: 10.4103/0970-9290.107393.
- Background: PubMed 9021321Kjaerheim V, Skaare A, Barkvoll P, Rolla G. Antiplaque, antibacterial, and anti-inflammatory properties of triclosan mouthrinses in combination with zinc citrate or polyvinylmethylether maleic acid (PVM-MA) copolymer. Eur J Oral Sci. 1996 Oct-Dec;104(5-6):529-34. doi: 10.1111/j.1600-0722.1996.tb00137.x.
- Background: PubMed 17085522Lang C, Murgia C, Leong M, Tan LW, Perozzi G, Knight D, Ruffin R, Zalewski P. Anti-inflammatory effects of zinc and alterations in zinc transporter mRNA in mouse models of allergic inflammation. Am J Physiol Lung Cell Mol Physiol. 2007 Feb;292(2):L577-84. doi: 10.1152/ajplung.00280.2006. Epub 2006 Nov 3.
- Background: PubMed 11326448Leggat PA, Kedjarune U. Bacterial aerosols in the dental clinic: a review. Int Dent J. 2001 Feb;51(1):39-44. doi: 10.1002/j.1875-595x.2001.tb00816.x.
- Individual participant dataSharing planned: Yes. September 2016
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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.
Magda Feres, Professor study chair
Guarulhos University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dental prophylaxis, Mouthwash CPC+Zn+F and Mouthwash CHX in people with Chronic Periodontitis, run by University of Guarulhos.
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 5 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 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Difference between groups (test, positive control, negative control A and negative control B) for the mean number of total colony-forming units (CFUs) in all plates. (time frame: During oral prophylaxis procedure.). 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 NCT02875769, which also lists 34 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 4 Jun 2020.