PeriodontitisLacerINTNCT04881357
Antiplaque/Antigingivitis Effect of Lacer Oros Integral
A study testing test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain). in people with Periodontitis and Dental Plaque, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Dental Plaque, Gingival Inflammation
- What is being tested?
- test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain).
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 4 Sep 2021to 10 Jul 2022
- 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 35 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 35-64 years old.
- Periodontitis patients, already enrolled in a SPT, for at least 6 months, and the last SPT visit in the previous 6 months.
- 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.
- Moderate gingival inflammation (≥40% bleeding on marginal probing, BOMP) (Van der Weijden, Timmerman, Nijboer, Reijerse, \& Van der Velden, 1994) and Turesky plaque index ≥1.5. Also 2017 World Workshop criteria and bleeding on probing (BOP) (Ainamo \& Bay, 1975) criteria will be considered. The primary criteria will be BOP ≥30% and Turesky plaque index ≥1.5
- No orthodontic banding or removable prosthesis.
- Subjects willing to participate and comply with the requirements of the study.
- Complains of dentin hypersensitivity in, at least, one evaluable tooth. Dentin hypersensitivity will be confirmed with evaporative sensitivity (Schiff et al., 1994), with a minimum score of 2-3 (West et al., 2013), although a score of 1 will also be considered as adequate. In order to be eligible, the selected tooth must not have a current desensitizing therapy, must not have been restored in the last 3 moths, or have a crown or a big restoration. Only incisors, canines and premolars will be considered (Holland, Narhi, Addy, Gangarosa, \& Orchardson, 1997).
Who cannot join
- Untreated or uncontrolled periodontitis
- Regular use of antiseptic-containing and/or anti-hypersensitivity mouth rinses.
- Antibiotic intake within the previous month.
- Excessive exposure to acids (eating disorders, chronic regurgitation).
- 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 requires antibiotic prophylaxis (infectious endocarditis, cardiac valve prosthesis…).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Antiplaque and Antigingivitis Effects of the New "Lacer Oros Acción Integral" Mouth Rinse Formulation.
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.
Read more
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.
- Conditions
- Periodontitis, Dental Plaque, Gingival Inflammation
- Being tested
- test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain)., control group
- Medical subject headings
- Periodontitis, Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
control groupOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain). |
| 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). Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BOP (Baseline-12 weeks)
Gingival Bleeding Index (Ainamo \& Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Measured: Change from baseline to 12 weeks
Secondary outcomes (58)
Change in BOP (Baseline-6 weeks)
Gingival Bleeding Index (Ainamo \& Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Measured: 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.
Measured: Change from 6 to 12 weeks
BOP_baseline
Gingival Bleeding Index (Ainamo \& Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Measured: Baseline
BOP_6 weeks
Gingival Bleeding Index (Ainamo \& Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Measured: 6 weeks
BOP_12 weeks
Gingival Bleeding Index (Ainamo \& Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Probing pocket depth_baseline
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Measured: Baseline
Probing pocket depth_6 weeks
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Measured: 6 weeks
Probing pocket depth_12 weeks
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Measured: 12 weeks
Recession_baseline
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Measured: Baseline
Recession_6 weeks
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Measured: 6 weeks
Recession_12 weeks
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start4 Sep 2021
- Primary completion10 Jul 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Parallel groups
- Model description
- pilot, parallel, double-blind, randomized, placebo-controlled, 12-week, clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Lacer S.A.
- Responsible party
- Sponsor
- Investigators
- David Herrera, Prof, Principal investigator, University Complutense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881357
- Sponsor's protocol ID
- 20/750-EC_X
- Acronym
- LacerINT
- Status last verified
- Jul 2023
- First submitted
- 26 Apr 2021
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data would be made available upon a reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antiplaque and Antigingivitis Effects of the New "Lacer Oros Acción Integral" Mouth Rinse Formulation.
- ClinicalTrials.gov ID
- NCT04881357
- Acronym / sponsor ID
- LacerINT / 20/750-EC_X
- Conditions
- Periodontitis, Dental Plaque, Gingival Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Lacer S.A.
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 11 May 2021 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- pilot, parallel, double-blind, randomized, placebo-controlled, 12-week, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain).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). |
| Control Group | Placebo comparator | Other: control groupThe 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). |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 35-64 years old.
- Periodontitis patients, already enrolled in a SPT, for at least 6 months, and the last SPT visit in the previous 6 months.
- 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.
- Moderate gingival inflammation (≥40% bleeding on marginal probing, BOMP) (Van der Weijden, Timmerman, Nijboer, Reijerse, \& Van der Velden, 1994) and Turesky plaque index ≥1.5. Also 2017 World Workshop criteria and bleeding on probing (BOP) (Ainamo \& Bay, 1975) criteria will be considered. The primary criteria will be BOP ≥30% and Turesky plaque index ≥1.5
Key exclusion criteria (8 listed)
- Untreated or uncontrolled periodontitis
- Regular use of antiseptic-containing and/or anti-hypersensitivity mouth rinses.
- Antibiotic intake within the previous month.
- Excessive exposure to acids (eating disorders, chronic regurgitation).
- Chronic use of analgesic or anti-inflammatory drugs.
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 |
|---|---|---|
| test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain).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). | Other | Experimental Group |
| control groupThe 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). | Other | Control Group |
Primary outcome
Change in BOP (Baseline-12 weeks)
Time frame: Change from baseline to 12 weeks
Gingival Bleeding Index (Ainamo \& Bay, 1975), by dichotomously assessing bleeding after gentle probing.
58 secondary outcomes
Change in BOP (Baseline-6 weeks)
Time frame: Change from baseline to 6 weeks
Change in BOP (6-12 weeks)
Time frame: Change from 6 to 12 weeks
BOP_baseline
Time frame: Baseline
BOP_6 weeks
Time frame: 6 weeks
BOP_12 weeks
Time frame: 12 weeks
BOMP_baseline
Time frame: Baseline
BOMP_6 weeks
Time frame: 6 weeks
BOMP_12 weeks
Time frame: 12 weeks
Change in BOMP (Baseline-12 weeks)
Time frame: Change from baseline to 12 weeks
Change in BOMP (Baseline-6 weeks)
Time frame: Change from baseline to 6 weeks
Change in BOMP (6-12 weeks)
Time frame: Change from 6 to 12 weeks
Change in Dental Plaque (Baseline-12 weeks)
Time frame: Change from baseline to 12 weeks
Change in Dental Plaque (Baseline-6 weeks)
Time frame: Change from baseline to 6 weeks
Change in Dental Plaque (6-12 weeks)
Time frame: Change from 6 to 12 weeks
Dental Plaque_Baseline
Time frame: Baseline
Dental Plaque_6 weeks
Time frame: 6 weeks
Dental Plaque_12 weeks
Time frame: 12 weeks
Staining of teeth_baseline
Time frame: Baseline
Staining of teeth_6 weeks
Time frame: 6 weeks
Staining of teeth_12 weeks
Time frame: 12 weeks
Probing pocket depth_baseline
Time frame: Baseline
Probing pocket depth_6 weeks
Time frame: 6 weeks
Probing pocket depth_12 weeks
Time frame: 12 weeks
Recession_baseline
Time frame: Baseline
Recession_6 weeks
Time frame: 6 weeks
Recession_12 weeks
Time frame: 12 weeks
Dentin hypersensitivity_baseline
Time frame: Baseline
Dentin hypersensitivity_6 weeks
Time frame: 6 weeks
Dentin hypersensitivity_12 weeks
Time frame: 12 weeks
Patient reported outcomes-1_6 weeks
Time frame: 6 weeks
Patient reported outcomes-1_12 weeks
Time frame: 12 weeks
Patient reported outcomes-2_6 weeks
Time frame: 6 weeks
Patient reported outcomes-2_12 weeks
Time frame: 12 weeks
Patient reported outcomes-3_6 weeks
Time frame: 6 weeks
Patient reported outcomes-3_12 weeks
Time frame: 12 weeks
Patient reported outcomes-4_6 weeks
Time frame: 6 weeks
Patient reported outcomes-4_12 weeks
Time frame: 12 weeks
Patient reported outcomes-5_6 weeks
Time frame: 6 weeks
Patient reported outcomes-5_12 weeks
Time frame: 12 weeks
Patient reported outcomes-6_6 weeks
Time frame: 6 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 25 Jul 2023.
- Individual participant dataSharing planned: No. Data would be made available upon a reasonable request
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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
University Complutense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain). in people with Periodontitis and Dental Plaque, 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 8 inclusion and 8 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 25 Jul 2023. 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?
Change in BOP (Baseline-12 weeks) (time frame: Change from baseline to 12 weeks). 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 25 Jul 2023.