Clinical trial NCT04881357: Antiplaque/Antigingivitis Effect of Lacer Oros Integral
Official title: Evaluation of Antiplaque and Antigingivitis Effects of the New "Lacer Oros Acción Integral" Mouth Rinse Formulation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Dental Plaque
Gingival Inflammation
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Lacer, S.A.
First posted: 2021-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilot, parallel, double-blind, randomized, placebo-controlled, 12-week, clinical trial
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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...).

Primary outcomes:
measure: Change in BOP (Baseline-12 weeks)
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Change in BOP (Baseline-6 weeks)
timeFrame: Change from baseline to 6 weeks
measure: Change in BOP (6-12 weeks)
timeFrame: Change from 6 to 12 weeks
measure: BOP_baseline
timeFrame: Baseline
measure: BOP_6 weeks
timeFrame: 6 weeks
measure: BOP_12 weeks
timeFrame: 12 weeks
measure: BOMP_baseline
timeFrame: Baseline
measure: BOMP_6 weeks
timeFrame: 6 weeks
measure: BOMP_12 weeks
timeFrame: 12 weeks
measure: Change in BOMP (Baseline-12 weeks)
timeFrame: Change from baseline to 12 weeks
measure: Change in BOMP (Baseline-6 weeks)
timeFrame: Change from baseline to 6 weeks
measure: Change in BOMP (6-12 weeks)
timeFrame: Change from 6 to 12 weeks
measure: Change in Dental Plaque (Baseline-12 weeks)
timeFrame: Change from baseline to 12 weeks
measure: Change in Dental Plaque (Baseline-6 weeks)
timeFrame: Change from baseline to 6 weeks
measure: Change in Dental Plaque (6-12 weeks)
timeFrame: Change from 6 to 12 weeks
measure: Dental Plaque_Baseline
timeFrame: Baseline
measure: Dental Plaque_6 weeks
timeFrame: 6 weeks
measure: Dental Plaque_12 weeks
timeFrame: 12 weeks
measure: Staining of teeth_baseline
timeFrame: Baseline
measure: Staining of teeth_6 weeks
timeFrame: 6 weeks
measure: Staining of teeth_12 weeks
timeFrame: 12 weeks
measure: Probing pocket depth_baseline
timeFrame: Baseline
measure: Probing pocket depth_6 weeks
timeFrame: 6 weeks
measure: Probing pocket depth_12 weeks
timeFrame: 12 weeks
measure: Recession_baseline
timeFrame: Baseline
measure: Recession_6 weeks
timeFrame: 6 weeks
measure: Recession_12 weeks
timeFrame: 12 weeks
measure: Dentin hypersensitivity_baseline
timeFrame: Baseline
measure: Dentin hypersensitivity_6 weeks
timeFrame: 6 weeks
measure: Dentin hypersensitivity_12 weeks
timeFrame: 12 weeks
measure: Patient reported outcomes-1_6 weeks
timeFrame: 6 weeks
measure: Patient reported outcomes-1_12 weeks
timeFrame: 12 weeks
measure: Patient reported outcomes-2_6 weeks
timeFrame: 6 weeks
measure: Patient reported outcomes-2_12 weeks
timeFrame: 12 weeks
measure: Patient reported outcomes-3_6 weeks
timeFrame: 6 weeks
measure: Patient reported outcomes-3_12 weeks
timeFrame: 12 weeks
measure: Patient reported outcomes-4_6 weeks
timeFrame: 6 weeks
measure: Patient reported outcomes-4_12 weeks
timeFrame: 12 weeks
measure: Patient reported outcomes-5_6 weeks
timeFrame: 6 weeks
measure: Patient reported outcomes-5_12 weeks
timeFrame: 12 weeks
measure: Patient reported outcomes-6_6 weeks
timeFrame: 6 weeks
measure: Patient reported outcomes-6_12 weeks
timeFrame: 12 weeks
measure: Patient reported outcomes-7_6 weeks
timeFrame: 6 weeks
measure: Patient reported outcomes-7_12 weeks
timeFrame: 12 weeks
measure: Patient reported outcomes-8_6 weeks
timeFrame: 6weeks
measure: Patient reported outcomes-8_12 weeks
timeFrame: 12 weeks
measure: Patient reported outcomes-9_6 weeks
timeFrame: 6 weeks
measure: Patient reported outcomes-9_12 weeks
timeFrame: 12 weeks
measure: Compliance_6 weeks
timeFrame: 12 weeks
measure: Compliance_12 weeks
timeFrame: 12 weeks
measure: Total counts (CFU/ml)_Baseline
timeFrame: Baseline
measure: Total counts (CFU/ml)_6 weeks
timeFrame: 6 weeks
measure: Total counts (CFU/ml)_12 weeks
timeFrame: 12 weeks
measure: Proportion of periodontal pathogens (%)_Baseline
timeFrame: Baseline
measure: Proportion of periodontal pathogens (%)_6 weeks
timeFrame: 6 weeks
measure: Proportion of periodontal pathogens (%)_12 weeks
timeFrame: 12 weeks
measure: Prevalence of periodontal pathogens (%) in each group_baseline
timeFrame: Baseline
measure: Prevalence of periodontal pathogens (%) in each group_6 weeks
timeFrame: 6 weeks
measure: Prevalence of periodontal pathogens (%) in each group_12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Faculty of Dentistry, Univesity Complutense, Madrid
Study officials:
affiliation: University Complutense
name: David Herrera, Prof
role: PRINCIPAL_INVESTIGATOR
References: