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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
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).
Faculty of Dentistry, Univesity Complutense, Madrid
Madrid, Spain
Change in BOP (Baseline-12 weeks)
Gingival Bleeding Index (Ainamo \& Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Time frame: Change from baseline to 12 weeks
Change in BOP (Baseline-6 weeks)
Gingival Bleeding Index (Ainamo \& Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Time frame: Change from baseline to 6 weeks
Change in BOP (6-12 weeks)
Gingival Bleeding Index (Ainamo \& Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Time frame: Change from 6 to 12 weeks
BOP_baseline
Gingival Bleeding Index (Ainamo \& Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Time frame: Baseline
BOP_6 weeks
Gingival Bleeding Index (Ainamo \& Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Time frame: 6 weeks
BOP_12 weeks
Gingival Bleeding Index (Ainamo \& Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Probing pocket depth_baseline
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Time frame: Baseline
Probing pocket depth_6 weeks
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Time frame: 6 weeks
Probing pocket depth_12 weeks
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Time frame: 12 weeks
Recession_baseline
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Time frame: Baseline
Recession_6 weeks
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Time frame: 6 weeks
Recession_12 weeks
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
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