Antiplaque/Antigingivitis Effect of Lacer Oros Integral

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.

Conditions

• Periodontitis
• Dental Plaque
• Gingival Inflammation

Interventions

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).

OTHER

control group

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).

Sponsors & Collaborators

• Lacer, S.A.

  collaborator UNKNOWN

• Universidad Complutense de Madrid

  lead OTHER

Principal Investigators

• David Herrera, Prof · University Complutense

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-09-04

Primary Completion

2022-07-10

Completion

2022-07-10

Countries

• Spain

Study Locations