Antiplaque/Antigingivitis Effect of Lacer Oros Integral (LacerINT)

Universidad Complutense de Madrid

Status: Completed

Conditions: Periodontitis; Dental Plaque; Gingival Inflammation

Treatments: Other: test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain).; Other: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT04881357

20/750-EC_X

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 35 to 64 years old

Volunteers: Accepts Healthy Volunteers

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...).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

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).

Treatment:

Other: test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain).

Control Group

Placebo Comparator group

Description:

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).

Treatment:

Other: control group