Tooth StainingPaSTainingNCT05354986
Impact of a Newly Formulated Toothpaste in Tooth Staining Associated With Chlorhexidine Rinses
A study testing Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP) and Toothpaste without hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP) in people with Tooth Staining and Periodontitis, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Dental staining may interfere with compliance with chlorhexidine mouth rinse use Thus, developing strategies to control tooth staining associated with chlorhexidine use may be relevant for improving compliance. Read more about this study
- Who is it for?
- Ages 30 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Staining, Periodontitis
- What is being tested?
- Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP) and Toothpaste without hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2022to 31 Jan 2024
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 30-69 years old.
- Periodontitis patients, in stages I-III, requiring steps 1 and 2 of periodontal treatment including full-mouth subgingival instrumentation.
- Systemically healthy, following the criteria of the American Society of Anesthesiologists (ASA), for patients ASA type I or II (see also exclusion criteria).
- Presence of at least three evaluable teeth in each quadrant.
- No orthodontic banding or removable prosthesis.
- Subjects willing to participate and comply with the requirements of the study.
Who cannot join
- Acute periodontal conditions.
- Antibiotic intake within the previous month.
- Chronic use of analgesic or anti-inflammatory drugs.
- Pregnant women.
- Any adverse medical history (diabetes, osteoporosis, immunosuppression…) or long-term medication (chemotherapy and immunosuppression treatment; pharmacological treatment associated with gingival overgrowth such as the use of phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, amlodipine, verapamil, cyclosporine) influencing gingival conditions.
- Conditions which require antibiotic prophylaxis (infectious endocarditis, cardiac valve prosthesis…).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Dentistry, University Complutense of Madrid (UCM)
Madrid, 28040
About this study
Official title: Impact of a Newly Formulated Tooth Paste in the Prevention/Elimination of Tooth Staining Associated With Adjunctive Use Chlorhexidine Mouth Rinses to Subgingival Instrumentation. A Randomized Clinical Trial
Dental staining may interfere with compliance with chlorhexidine mouth rinse use
Thus, developing strategies to control tooth staining associated with chlorhexidine use may be relevant for improving compliance. Thus, a new anti-staining toothpaste formulation (Dentaid, Barcelona, Spain) has been recently developed, aiming to interfere with the development of extrinsic staining associated with chlorhexidine use (preventive action), but also with the capacity of removing staining already formed. For that, the proposed formulation includes hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP), within its ingredients. Thus, it may be relevant to test the efficacy of this new anti-staining toothpaste formulation in two consecutive randomized clinical trials (RCTs).
Objectives The primary objective of these RCTs will be to evaluate the capacity of preventing tooth staining, associated with the use of a chlorhexidine mouth rinse, adjunctive to subgingival instrumentation (step 2 of periodontal therapy) (RCT #1). As secondary objective, the capacity of eliminating or reducing tooth staining already present will be assessed (RCT #2).
Read the detailed description
The primary objective of these RCTs will be to evaluate the capacity of preventing tooth staining, associated with the use of a chlorhexidine mouth rinse, adjunctive to subgingival instrumentation (step 2 of periodontal therapy) (RCT #1). As secondary objective, the capacity of eliminating or reducing tooth staining already present will be assessed (RCT #2).
Additional objectives will include to test: (1) the safety of the tested formulation, in terms of adverse events and tolerability; (2) patient´s evaluation of the product, by means of patient-reported outcome measures (PROMs); and (3) clinical impact of the tested formulation in terms of periodontal clinical outcomes.
Consecutive subjects, referred to the Post-Graduate Periodontal Clinic in the University Complutense, Madrid, seeking for treatment of periodontitis in stages I-III will be screened, and enrolled in the clinical trials if they fulfil the following criteria and accept to participate by filling an informed consent
Two consecutive parallel, double-blind, randomized, placebo-controlled, 2-week, clinical trials have been designed.
Screening visit After completing a questionnaire including the subject's medical health status, medication and smoking habit [smoker defined when currently smoking ≥ 9 cigarettes per day], a careful oral health evaluation will be carried out. If subjects met the inclusion/exclusion criteria, the investigator will inform them about the aims and details of the study and will request their voluntary participation. Once they accept, by signing the Institutional Review Board (IRB) approved informed consent form, they will be enrolled in the study.
Pre-treatment visit At this visit the oral health of each participant, identified by a unique trial number, will be examined. Clinical parameters will be recorded around all teeth, except the third molars.
Treatment visits All interventions, included in the steps 1 and 2 of periodontal therapy will be implemented according to the patient´s needs. Specifically, subgingival instrumentation will be performed in two sessions, with a maximum interval of one week, with hand and automatic devices, under local anaesthesia. Full-mouth dental polishing (air-polishing) will be performed immediately after the second session, to eliminate any dental staining.
Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. Randomization will be performed using true random numbers from a computer-generated list, stratified for tobacco smoking (smokers of 10 or more cigarettes per day versus other smokers, former smokers and non-smokers):
- The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.
- The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse,
All subjects will be masked to their group allocation and will receive their assigned products kit containing: a manual toothbrush (Vitis Suave, Dentaid, Barcelona, Spain), the test or placebo toothpaste, and the mouth rinse with dose caps. They will be instructed to brush with the toothpaste (the amount of a pee size) for 2 minutes, twice daily, and then rinse for 30 seconds with 15 mL of the mouth rinse, twice daily. Standardized instructions will be given for mechanical supragingival biofilm control, including the use of interdental brushes (Interprox®, Dentaid, Barcelona, Spain). Each subject will receive standardized verbal and written instructions on how to use the assigned products.
2-week visit (final visit, RCT #1; initial visit, RCT #2) Two weeks after the second session of subgingival instrumentation, an oral examination will be performed to evaluate possible adverse effect, and dental plaque index will be recorded. Clinical photographs will be also taken to assess staining (four, for sextants 2 and 5, for buccal and palatal surfaces).
The subjects will be asked about the occurrence of any adverse effects. A questionnaire on product usage and perceptions (PROMs), dietary habits and compliance with product use will be filled by the patients. The study coordinator will collect the empty and unused tubes and bottles. Subjects will be provided with a new kit containing the necessary assigned products.
Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. Thus, at the 2-week visit, half of each group will continue with the same toothpaste and the other half will change toothpaste, creating four different groups, when considering both RCTs: group control-control, group control-test, group test-control, group test-test)
4-week visit (final visit, RCT #2) After 4 weeks, a comprehensive oral examination will be performed, including the assessment of clinical variables. The subjects will be asked about the occurrence of any adverse effects and the study coordinator will collect the empty and unused tubes. A new questionnaire on product usage and perceptions (PROMs), dietary habits and compliance with product use will be filled by the patients.
Clinical photographs (four, for sextants 2 and 5, for buccal and palatal surfaces) will be also taken to assess staining. All subjects will be provided with a professional dental prophylaxis at the end of the study.
- Conditions
- Tooth Staining, Periodontitis
- Being tested
- Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP), Toothpaste without hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)
- Keywords
- Tooth staining, Periodontitis, Chlorhexidine, tripolyphosphate and polyvinylpyrrolidone (PVP)
- Medical subject headings
- Tooth Discoloration, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)Other
Subgingival instrumentation will be performed in two sessions, with a maximum interval of one week, with hand and automatic devices, under local anaesthesia. Full-mouth dental polishing (air-polishing) will be performed immediately after the second session, to eliminate any dental staining.
Experimental anti-staining toothpaste formulation (Dentaid, Barcelona, Spain) includes hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP), within its ingredients. Participants will use the test or control toothpaste three times daily with a manual toothbrush followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.
Toothpaste without hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)Other
Subgingival instrumentation will be performed in two sessions, with a maximum interval of one week, with hand and automatic devices, under local anaesthesia. Full-mouth dental polishing (air-polishing) will be performed immediately after the second session, to eliminate any dental staining.
Experimental anti-staining toothpaste formulation without tripolyphosphate and polyvinylpyrrolidone (PVP), within its ingredients. Participants will use the test or control toothpaste three times daily with a manual toothbrush followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.
| Study group | Role | What they receive |
|---|---|---|
| Control-Control | Placebo comparator | Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo.
0-2 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse.
Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste.
2-4 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse. Receives: Other: Toothpaste without hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP) |
| Control-test | Experimental | Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo.
0-2 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse.
Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste.
2-4 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse. Receives: Other: Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP) |
| Test-control | Experimental | Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo.
0-2 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.
Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste.
2-4 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse. Receives: Other: Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP) |
| Test-test | Experimental | Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo.
0-2 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.
Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste.
2-4 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse. Receives: Other: Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth Staining
GRÜNDEMANN MODIFIED STAIN INDEX (GMSI) (Gründemann et al., 2000). 2. Photographs of buccal and lingual/palatal areas of lower and upper anterior teeth, from canine to canine.
The zones to be scored, buccal only:
Mesial (A), Distal (A), Gingival (G) and Incisal (I)
The intensity in each zone will be scored using the following criteria described by Lobene (Lobene, 1968):
Score=0 No stain Score=1 Light stain Score=2 Moderate stain Score=3 Heavy stain
Measured: 2 weeks
Tooth Staining
GRÜNDEMANN MODIFIED STAIN INDEX (GMSI) (Gründemann et al., 2000). 2. Photographs of buccal and lingual/palatal areas of lower and upper anterior teeth, from canine to canine.
The zones to be scored, buccal only:
Mesial (A), Distal (A), Gingival (G) and Incisal (I)
The intensity in each zone will be scored using the following criteria described by Lobene (Lobene, 1968):
Score=0 No stain Score=1 Light stain Score=2 Moderate stain Score=3 Heavy stain
Measured: 4 weeks
Secondary outcomes (13)
Dental plaque
Turesky et al. (Turesky, Gilmore, \& Glickman, 1970) modification of the Quigley and Hein index (Quigley \& Hein, 1962). Scale: 0-5.
Score=0 No Plaque Score=1 The presence of a discontinuous line of plaque at the gingival margin e.g. small islands Score=2 A continuous line of plaque at the gingival margin which does not extend greater than 1 mm from the margin Score=3 Plaque coverage which is greater than 1 mm but does not extend more than one third of the tooth Score=4 Plaque which covers more than one third but not more than two third of the tooth surface Score=5 Plaque coverage over more than two third of the tooth surface.
Measured: 0 weeks
Dental plaque
Turesky et al. (Turesky, Gilmore, \& Glickman, 1970) modification of the Quigley and Hein index (Quigley \& Hein, 1962) Score=0 No Plaque Score=1 The presence of a discontinuous line of plaque at the gingival margin e.g. small islands Score=2 A continuous line of plaque at the gingival margin which does not extend greater than 1 mm from the margin Score=3 Plaque coverage which is greater than 1 mm but does not extend more than one third of the tooth Score=4 Plaque which covers more than one third but not more than two third of the tooth surface Score=5 Plaque coverage over more than two third of the tooth surface.
Measured: 2 weeks
Dental plaque
Turesky et al. (Turesky, Gilmore, \& Glickman, 1970) modification of the Quigley and Hein index (Quigley \& Hein, 1962) Score=0 No Plaque Score=1 The presence of a discontinuous line of plaque at the gingival margin e.g. small islands Score=2 A continuous line of plaque at the gingival margin which does not extend greater than 1 mm from the margin Score=3 Plaque coverage which is greater than 1 mm but does not extend more than one third of the tooth Score=4 Plaque which covers more than one third but not more than two third of the tooth surface Score=5 Plaque coverage over more than two third of the tooth surface.
Measured: 4 weeks
Gingival condition
Gingival Bleeding Index (Ainamo \& Bay, 1975)
Measured: 0 weeks
Gingival condition
Gingival Bleeding Index (Ainamo \& Bay, 1975)
Measured: 4 weeks
Probing depth (PD)
Distance from the gingival margin to the base of the pocket (mm)
Measured: 0 weeks
Probing depth (PD)
Distance from the gingival margin to the base of the pocket (mm)
Measured: 4 weeks
Recession (REC)
Distance from the gingival margin to the cemento-enamel junction (mm)
Measured: 0 weeks
Recession (REC)
Distance from the gingival margin to the cemento-enamel junction (mm)
Measured: 4 weeks
Patient-reported outcome measures (PROMs)
A predefined questionnaire will be filled by the patient, on product usage and perceptions, and also on possible factors influencing tooth staining, such as the consumption of certain foods and drinks, as well as compliance with product use.
Measured: 2 weeks
Patient-reported outcome measures (PROMs)
A predefined questionnaire will be filled by the patient, on product usage and perceptions, and also on possible factors influencing tooth staining, such as the consumption of certain foods and drinks, as well as compliance with product use.
Measured: 4 weeks
Compliance
The study coordinator will collect, at each study visit, the compliance forms, filled by the patients, as well as the empty and unused tubes and mouth rinse bottles. In the compliance forms, information about the number of times a day has the patient used the dentifrices and the rinses during the whole study period will be recorded.
Measured: 2 weeks
Compliance
The study coordinator will collect, at each study visit, the compliance forms, filled by the patients, as well as the empty and unused tubes and mouth rinse bottles. In the compliance forms, information about the number of times a day has the patient used the dentifrices and the rinses during the whole study period will be recorded.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Oct 2022
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth StainingStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Two consecutive parallel, double-blind, randomized, placebo-controlled, 2-week, clinical trials
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Dentaid SL
- Responsible party
- Sponsor
- Investigators
- David Herrera, Prof., Principal investigator, Etiology and Therapy of Periodontal and Periimplant Research Group (ETEP). Faculty of Dentistry. University Complutense of Madrid (UCM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354986
- Sponsor's protocol ID
- 68-071021
- Other IDs
- 21/546-EC_X
- Acronym
- PaSTaining
- Status last verified
- Jul 2023
- First submitted
- 19 Apr 2022
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Newly Formulated Tooth Paste in the Prevention/Elimination of Tooth Staining Associated With Adjunctive Use Chlorhexidine Mouth Rinses to Subgingival Instrumentation. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05354986
- Acronym / sponsor ID
- PaSTaining / 68-071021
- Conditions
- Tooth Staining, Periodontitis
- Keywords
- Tooth staining, Periodontitis, Chlorhexidine, tripolyphosphate and polyvinylpyrrolidone (PVP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Dentaid SL
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 2 May 2022 (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.
Dental staining may interfere with compliance with chlorhexidine mouth rinse use
Thus, developing strategies to control tooth staining associated with chlorhexidine use may be relevant for improving compliance. Thus, a new anti-staining toothpaste formulation (Dentaid, Barcelona, Spain) has been recently developed, aiming to interfere with the development of extrinsic staining associated with chlorhexidine use (preventive action), but also with the capacity of removing staining already formed. For that, the proposed formulation includes hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP), within its ingredients. Thus, it may be relevant to test the efficacy of this new anti-staining toothpaste formulation in two consecutive randomized clinical trials (RCTs).
Objectives The primary objective of these RCTs will be to evaluate the capacity of preventing tooth staining, associated with the use of a chlorhexidine mouth rinse, adjunctive to subgingival instrumentation (step 2 of periodontal therapy) (RCT #1). As secondary objective, the capacity of eliminating or reducing tooth staining already present will be assessed (RCT #2).
Detailed description
The primary objective of these RCTs will be to evaluate the capacity of preventing tooth staining, associated with the use of a chlorhexidine mouth rinse, adjunctive to subgingival instrumentation (step 2 of periodontal therapy) (RCT #1). As secondary objective, the capacity of eliminating or reducing tooth staining already present will be assessed (RCT #2).
Additional objectives will include to test: (1) the safety of the tested formulation, in terms of adverse events and tolerability; (2) patient´s evaluation of the product, by means of patient-reported outcome measures (PROMs); and (3) clinical impact of the tested formulation in terms of periodontal clinical outcomes.
Consecutive subjects, referred to the Post-Graduate Periodontal Clinic in the University Complutense, Madrid, seeking for treatment of periodontitis in stages I-III will be screened, and enrolled in the clinical trials if they fulfil the following criteria and accept to participate by filling an informed consent
Two consecutive parallel, double-blind, randomized, placebo-controlled, 2-week, clinical trials have been designed.
Screening visit After completing a questionnaire including the subject's medical health status, medication and smoking habit [smoker defined when currently smoking ≥ 9 cigarettes per day], a careful oral health evaluation will be carried out. If subjects met the inclusion/exclusion criteria, the investigator will inform them about the aims and details of the study and will request their voluntary participation. Once they accept, by signing the Institutional Review Board (IRB) approved informed consent form, they will be enrolled in the study.
Pre-treatment visit At this visit the oral health of each participant, identified by a unique trial number, will be examined. Clinical parameters will be recorded around all teeth, except the third molars.
Treatment visits All interventions, included in the steps 1 and 2 of periodontal therapy will be implemented according to the patient´s needs. Specifically, subgingival instrumentation will be performed in two sessions, with a maximum interval of one week, with hand and automatic devices, under local anaesthesia. Full-mouth dental polishing (air-polishing) will be performed immediately after the second session, to eliminate any dental staining.
Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. Randomization will be performed using true random numbers from a computer-generated list, stratified for tobacco smoking (smokers of 10 or more cigarettes per day versus other smokers, former smokers and non-smokers):
- The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.
- The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse,
All subjects will be masked to their group allocation and will receive their assigned products kit containing: a manual toothbrush (Vitis Suave, Dentaid, Barcelona, Spain), the test or placebo toothpaste, and the mouth rinse with dose caps. They will be instructed to brush with the toothpaste (the amount of a pee size) for 2 minutes, twice daily, and then rinse for 30 seconds with 15 mL of the mouth rinse, twice daily. Standardized instructions will be given for mechanical supragingival biofilm control, including the use of interdental brushes (Interprox®, Dentaid, Barcelona, Spain). Each subject will receive standardized verbal and written instructions on how to use the assigned products.
2-week visit (final visit, RCT #1; initial visit, RCT #2) Two weeks after the second session of subgingival instrumentation, an oral examination will be performed to evaluate possible adverse effect, and dental plaque index will be recorded. Clinical photographs will be also taken to assess staining (four, for sextants 2 and 5, for buccal and palatal surfaces).
The subjects will be asked about the occurrence of any adverse effects. A questionnaire on product usage and perceptions (PROMs), dietary habits and compliance with product use will be filled by the patients. The study coordinator will collect the empty and unused tubes and bottles. Subjects will be provided with a new kit containing the necessary assigned products.
Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. Thus, at the 2-week visit, half of each group will continue with the same toothpaste and the other half will change toothpaste, creating four different groups, when considering both RCTs: group control-control, group control-test, group test-control, group test-test)
4-week visit (final visit, RCT #2) After 4 weeks, a comprehensive oral examination will be performed, including the assessment of clinical variables. The subjects will be asked about the occurrence of any adverse effects and the study coordinator will collect the empty and unused tubes. A new questionnaire on product usage and perceptions (PROMs), dietary habits and compliance with product use will be filled by the patients.
Clinical photographs (four, for sextants 2 and 5, for buccal and palatal surfaces) will be also taken to assess staining. All subjects will be provided with a professional dental prophylaxis at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Two consecutive parallel, double-blind, randomized, placebo-controlled, 2-week, clinical trials
| Arm | Type | Receives |
|---|---|---|
| Control-Control | Placebo comparator | Other: Toothpaste without hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. 0-2 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. 2-4 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse. |
| Control-test | Experimental | Other: Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. 0-2 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. 2-4 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse. |
| Test-control | Experimental | Other: Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. 0-2 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. 2-4 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse. |
| Test-test | Experimental | Other: Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. 0-2 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. 2-4 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 30-69 years old.
- Periodontitis patients, in stages I-III, requiring steps 1 and 2 of periodontal treatment including full-mouth subgingival instrumentation.
- Systemically healthy, following the criteria of the American Society of Anesthesiologists (ASA), for patients ASA type I or II (see also exclusion criteria).
- Presence of at least three evaluable teeth in each quadrant.
- No orthodontic banding or removable prosthesis.
Key exclusion criteria (6 listed)
- Acute periodontal conditions.
- Antibiotic intake within the previous month.
- Chronic use of analgesic or anti-inflammatory drugs.
- Pregnant women.
- Any adverse medical history (diabetes, osteoporosis, immunosuppression…) or long-term medication (chemotherapy and immunosuppression treatment; pharmacological treatment associated with gingival overgrowth such as the use of phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, amlodipine, verapamil, cyclosporine) influencing gingival conditions.
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 |
|---|---|---|
| Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)Subgingival instrumentation will be performed in two sessions, with a maximum interval of one week, with hand and automatic devices, under local anaesthesia. Full-mouth dental polishing (air-polishing) will be performed immediately after the second session, to eliminate any dental staining. Experimental anti-staining toothpaste formulation (Dentaid, Barcelona, Spain) includes hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP), within its ingredients. Participants will use the test or control toothpaste three times daily with a manual toothbrush followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse. | Other | Control-test, Test-control, Test-test |
| Toothpaste without hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)Subgingival instrumentation will be performed in two sessions, with a maximum interval of one week, with hand and automatic devices, under local anaesthesia. Full-mouth dental polishing (air-polishing) will be performed immediately after the second session, to eliminate any dental staining. Experimental anti-staining toothpaste formulation without tripolyphosphate and polyvinylpyrrolidone (PVP), within its ingredients. Participants will use the test or control toothpaste three times daily with a manual toothbrush followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse. | Other | Control-Control |
Primary outcome
Tooth Staining
Time frame: 2 weeks
GRÜNDEMANN MODIFIED STAIN INDEX (GMSI) (Gründemann et al., 2000). 2. Photographs of buccal and lingual/palatal areas of lower and upper anterior teeth, from canine to canine. The zones to be scored, buccal only: Mesial (A), Distal (A), Gingival (G) and Incisal (I) The intensity in each zone will be scored using the following criteria described by Lobene (Lobene, 1968): Score=0 No stain Score=1 Light stain Score=2 Moderate stain Score=3 Heavy stain
Tooth Staining
Time frame: 4 weeks
GRÜNDEMANN MODIFIED STAIN INDEX (GMSI) (Gründemann et al., 2000). 2. Photographs of buccal and lingual/palatal areas of lower and upper anterior teeth, from canine to canine. The zones to be scored, buccal only: Mesial (A), Distal (A), Gingival (G) and Incisal (I) The intensity in each zone will be scored using the following criteria described by Lobene (Lobene, 1968): Score=0 No stain Score=1 Light stain Score=2 Moderate stain Score=3 Heavy stain
13 secondary outcomes
Dental plaque
Time frame: 0 weeks
Dental plaque
Time frame: 2 weeks
Dental plaque
Time frame: 4 weeks
Gingival condition
Time frame: 0 weeks
Gingival condition
Time frame: 4 weeks
Probing depth (PD)
Time frame: 0 weeks
Probing depth (PD)
Time frame: 4 weeks
Recession (REC)
Time frame: 0 weeks
Recession (REC)
Time frame: 4 weeks
Patient-reported outcome measures (PROMs)
Time frame: 2 weeks
Patient-reported outcome measures (PROMs)
Time frame: 4 weeks
Compliance
Time frame: 2 weeks
Compliance
Time frame: 4 weeks
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 9 May 2024.
- 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.
David Herrera, Prof. principal investigator
Etiology and Therapy of Periodontal and Periimplant Research Group (ETEP). Faculty of Dentistry. University Complutense of Madrid (UCM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP) and Toothpaste without hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP) in people with Tooth Staining and Periodontitis, run by Universidad Complutense de Madrid at 1 site in Spain.
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 6 inclusion and 6 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 9 May 2024. 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 Spain. 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?
Tooth Staining (time frame: 2 weeks). 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?
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 9 May 2024.