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| Name | Class |
|---|---|
| Lacer S.A. | INDUSTRY |
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Background; A new mouth rinse formulation ("Lacer Oros Acción Integral", Lacer SA, Barcelona, Spain) has been recently proposed, including O-Cymen-5-ol, potassium nitrate, zinc chloride, dipotassium glycyrrhizate, sodium fluoride, panthenol and xylitol, within its ingredients. Thus, it may be relevant to test the efficacy of this new "Lacer Oros Acción Integral" mouth rinse formulation in a RCT.
Primary Objective: The primary objective of this RCT will be to evaluate the antiplaque/antigingivitis effects of the test mouth rinse.
Population: Consecutive subjects in supportive periodontal therapy (SPT) will be screened at the Post-Graduate Periodontal Clinic in the University Complutense, Madrid, and enrolled in the clinical trial if they are periodontitis patients, already enrolled in a SPT, for at least 6 months, systemically healthy, with moderate gingival inflammation and complains of dentin hypersensitivity.
Study design: pilot, parallel, double-blind, randomized, placebo-controlled, 12-week, clinical trial
Intervention: The experimental group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain). The control group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the control mouth rinse (Lacer Oros Acción Integral - new formula, without active ingredients, Barcelona, Spain).
Visits: Screening, baseline, 2 and 12 weeks.
Outcomes: Periodontal clinical outcomes (plaque levels, gingival condition, probing pocket depth), Stainign, Microbiological outcomes (culture and qPCR). Patient reported outcomes, compliance, adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | The experimental group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain). |
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| Control Group | Placebo Comparator | The control group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the control mouth rinse (Lacer Oros Acción Integral - new formula, without active ingredients, Barcelona, Spain). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain). | Other | The experimental group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BOP (Baseline-12 weeks) | Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing. | Change from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BOP (Baseline-6 weeks) | Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing. | Change from baseline to 6 weeks |
| Change in BOP (6-12 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Herrera, Prof | University Complutense | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Univesity Complutense, Madrid | Madrid | 28040 | Spain |
Data would be made available upon a reasonable request
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D003773 | Dental Plaque |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003741 | Dental Deposits |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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pilot, parallel, double-blind, randomized, placebo-controlled, 12-week, clinical trial
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| control group | Other | The control group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the control mouth rinse (Lacer Oros Acción Integral - new formula, without active ingredients, Barcelona, Spain). |
|
Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing.
| Change from 6 to 12 weeks |
| BOP_baseline | Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing. | Baseline |
| BOP_6 weeks | Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing. | 6 weeks |
| BOP_12 weeks | Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing. | 12 weeks |
| BOMP_baseline | The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994). | Baseline |
| BOMP_6 weeks | The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994). | 6 weeks |
| BOMP_12 weeks | The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994). | 12 weeks |
| Change in BOMP (Baseline-12 weeks) | The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994). | Change from baseline to 12 weeks |
| Change in BOMP (Baseline-6 weeks) | The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994). | Change from baseline to 6 weeks |
| Change in BOMP (6-12 weeks) | The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994). | Change from 6 to 12 weeks |
| Change in Dental Plaque (Baseline-12 weeks) | Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth. | Change from baseline to 12 weeks |
| Change in Dental Plaque (Baseline-6 weeks) | Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth. | Change from baseline to 6 weeks |
| Change in Dental Plaque (6-12 weeks) | Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth. | Change from 6 to 12 weeks |
| Dental Plaque_Baseline | Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth. | Baseline |
| Dental Plaque_6 weeks | Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth. | 6 weeks |
| Dental Plaque_12 weeks | Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth. | 12 weeks |
| Staining of teeth_baseline | Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Gründemann, Timmerman, IJzerman, Van der Weijden, & Van der Weijden, 2000), recorded at nine areas per tooth (three mesial, three medial, three distal) (Koertge, Gunsolley, Domke, & Nelson, 1993). Stain will be graded using the intensity stain index of Lobene (Lobene, 1968). Presence of staining will be assessed in the upper and lower anterior buccal sites, by evaluating standardized clinical photographs by two calibrated examiners. | Baseline |
| Staining of teeth_6 weeks | Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Gründemann, Timmerman, IJzerman, Van der Weijden, & Van der Weijden, 2000), recorded at nine areas per tooth (three mesial, three medial, three distal) (Koertge, Gunsolley, Domke, & Nelson, 1993). Stain will be graded using the intensity stain index of Lobene (Lobene, 1968). Presence of staining will be assessed in the upper and lower anterior buccal sites, by evaluating standardized clinical photographs by two calibrated examiners. | 6 weeks |
| Staining of teeth_12 weeks | Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Gründemann, Timmerman, IJzerman, Van der Weijden, & Van der Weijden, 2000), recorded at nine areas per tooth (three mesial, three medial, three distal) (Koertge, Gunsolley, Domke, & Nelson, 1993). Stain will be graded using the intensity stain index of Lobene (Lobene, 1968). Presence of staining will be assessed in the upper and lower anterior buccal sites, by evaluating standardized clinical photographs by two calibrated examiners. | 12 weeks |
| Probing pocket depth_baseline | At six sites per tooth, with a millimetre periodontal probe (North Carolina) | Baseline |
| Probing pocket depth_6 weeks | At six sites per tooth, with a millimetre periodontal probe (North Carolina) | 6 weeks |
| Probing pocket depth_12 weeks | At six sites per tooth, with a millimetre periodontal probe (North Carolina) | 12 weeks |
| Recession_baseline | At six sites per tooth, with a millimetre periodontal probe (North Carolina) | Baseline |
| Recession_6 weeks | At six sites per tooth, with a millimetre periodontal probe (North Carolina) | 6 weeks |
| Recession_12 weeks | At six sites per tooth, with a millimetre periodontal probe (North Carolina) | 12 weeks |
| Dentin hypersensitivity_baseline | Dentin hypersensitivity will be explored by means of evaporative stimulus, with two distinct assessments: an objective assessment, using the Schiff scale (Schiff et al., 1994): a subjective assessment, using the Visual Analogue Scales (VAS), as reported by the patient. Dentin hypersensitivity will be scored in just one tooth, identified according to selection criteria, listed in the inclusion criteria. The same tooth will be also scored in the follow up visits. If the patient identifies more than one tooth with dentin hypersensitivity at baseline, the one with a higher level of pain (according to the patient evaluation), will be selected. The clinician will take the final decision concerning the selected tooth. | Baseline |
| Dentin hypersensitivity_6 weeks | Dentin hypersensitivity will be explored by means of evaporative stimulus, with two distinct assessments: an objective assessment, using the Schiff scale (Schiff et al., 1994): a subjective assessment, using the Visual Analogue Scales (VAS), as reported by the patient. Dentin hypersensitivity will be scored in just one tooth, identified according to selection criteria, listed in the inclusion criteria. The same tooth will be also scored in the follow up visits. If the patient identifies more than one tooth with dentin hypersensitivity at baseline, the one with a higher level of pain (according to the patient evaluation), will be selected. The clinician will take the final decision concerning the selected tooth. | 6 weeks |
| Dentin hypersensitivity_12 weeks | Dentin hypersensitivity will be explored by means of evaporative stimulus, with two distinct assessments: an objective assessment, using the Schiff scale (Schiff et al., 1994): a subjective assessment, using the Visual Analogue Scales (VAS), as reported by the patient. Dentin hypersensitivity will be scored in just one tooth, identified according to selection criteria, listed in the inclusion criteria. The same tooth will be also scored in the follow up visits. If the patient identifies more than one tooth with dentin hypersensitivity at baseline, the one with a higher level of pain (according to the patient evaluation), will be selected. The clinician will take the final decision concerning the selected tooth. | 12 weeks |
| Patient reported outcomes-1_6 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 1: Mouth rinse flavor (1: very bad; 10: very good). | 6 weeks |
| Patient reported outcomes-1_12 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 1: Mouth rinse flavor (1: very bad; 10: very good). | 12 weeks |
| Patient reported outcomes-2_6 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 2: How much time does the mouth rinse flavor lasts in your mouth (1: very low; 10: too much) | 6 weeks |
| Patient reported outcomes-2_12 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 2: How much time does the mouth rinse flavor lasts in your mouth (1: very low; 10: too much) | 12 weeks |
| Patient reported outcomes-3_6 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 3: Which is your perception of the food and drinks flavor when using the mouth rinse (1: much worse, 10: better). | 6 weeks |
| Patient reported outcomes-3_12 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 3: Which is your perception of the food and drinks flavor when using the mouth rinse (1: much worse, 10: better). | 12 weeks |
| Patient reported outcomes-4_6 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 4: Do you notice the teeth and the mucosa more sensitive after using the mouth rinse (1: no, absolutely; 10: yes, much more). | 6 weeks |
| Patient reported outcomes-4_12 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 4: Do you notice the teeth and the mucosa more sensitive after using the mouth rinse (1: no, absolutely; 10: yes, much more). | 12 weeks |
| Patient reported outcomes-5_6 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 5: Do you notice a drier mouth after using the mouth rinse (1: no, absolutely; 10: yes, much more). | 6 weeks |
| Patient reported outcomes-5_12 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 5: Do you notice a drier mouth after using the mouth rinse (1: no, absolutely; 10: yes, much more). | 12 weeks |
| Patient reported outcomes-6_6 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 6: Do you notice burning feeling after using the mouth rinse (1: no, absolutely; 10: yes, much more). | 6 weeks |
| Patient reported outcomes-6_12 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 6: Do you notice burning feeling after using the mouth rinse (1: no, absolutely; 10: yes, much more). | 12 weeks |
| Patient reported outcomes-7_6 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 7: Do you notice some staining on the teeth or tongue due to the use of the mouth rinse (1: no, absolutely; 10: yes, much more). | 6 weeks |
| Patient reported outcomes-7_12 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 7: Do you notice some staining on the teeth or tongue due to the use of the mouth rinse (1: no, absolutely; 10: yes, much more). | 12 weeks |
| Patient reported outcomes-8_6 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 8: Which is your general opinion after using the mouth rinse in this study (1: very bad; 10: very good). | 6weeks |
| Patient reported outcomes-8_12 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 8: Which is your general opinion after using the mouth rinse in this study (1: very bad; 10: very good). | 12 weeks |
| Patient reported outcomes-9_6 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 9: Do you think that the mouth rinse use has improved your mouth health (1: no absolutely; 10: yes, much more). | 6 weeks |
| Patient reported outcomes-9_12 weeks | A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 9: Do you think that the mouth rinse use has improved your mouth health (1: no absolutely; 10: yes, much more). | 12 weeks |
| Compliance_6 weeks | The study coordinator will collect, at each study visit, the compliance forms, filled by the patients, as well as the empty and unused mouth rinse bottles. | 12 weeks |
| Compliance_12 weeks | The study coordinator will collect, at each study visit, the compliance forms, filled by the patients, as well as the empty and unused mouth rinse bottles. | 12 weeks |
| Total counts (CFU/ml)_Baseline | Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR | Baseline |
| Total counts (CFU/ml)_6 weeks | Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR | 6 weeks |
| Total counts (CFU/ml)_12 weeks | Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR | 12 weeks |
| Proportion of periodontal pathogens (%)_Baseline | Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Proportions of microbiota would be calculated as counts of the pathogen/total counts. | Baseline |
| Proportion of periodontal pathogens (%)_6 weeks | Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Proportions of microbiota would be calculated as counts of the pathogen/total counts. | 6 weeks |
| Proportion of periodontal pathogens (%)_12 weeks | Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Proportions of microbiota would be calculated as counts of the pathogen/total counts. | 12 weeks |
| Prevalence of periodontal pathogens (%) in each group_baseline | Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Prevalence would be defined as presence/absence of each pathogen. | Baseline |
| Prevalence of periodontal pathogens (%) in each group_6 weeks | Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Prevalence would be defined as presence/absence of each pathogen. | 6 weeks |
| Prevalence of periodontal pathogens (%) in each group_12 weeks | Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Prevalence would be defined as presence/absence of each pathogen. | 12 weeks |
| D014076 |
| Tooth Diseases |
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D008722 | Methods |