Antiplaque/Antigingivitis Effect of Lacer Oros Integral

NCT04881357 | Completed

• 1 other identifier: 20/750-EC_X
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Dental Plaque; Gingival Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in BOP (Baseline-12 weeks)

  Gingival Bleeding Index (Ainamo \& Bay, 1975), by dichotomously assessing bleeding after gentle probing.

  Change from baseline to 12 weeks

Secondary Outcomes (58)

• Change in BOP (Baseline-6 weeks)

  Change from baseline to 6 weeks

• Change in BOP (6-12 weeks)

  Change from 6 to 12 weeks

• BOP_baseline

  Baseline

• BOP_6 weeks

  6 weeks

• BOP_12 weeks

  12 weeks

Study Arms (2)

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).

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).

Other: control group

Interventions

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).

Experimental Group

control group OTHER

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).

Control Group

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old.
• Periodontitis patients, already enrolled in a SPT, for at least 6 months, and the last SPT visit in the previous 6 months.

You may not qualify if:

• 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).
• 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…).

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Lacer S.A.: collaborator

Study Sites (1)

Faculty of Dentistry, Univesity Complutense, Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Periodontitis; Dental Plaque; Gingivitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases; Infections; Gingival Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• David Herrera, Prof

  University Complutense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pilot, parallel, double-blind, randomized, placebo-controlled, 12-week, clinical trial

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 11, 2021
• Study Start: September 4, 2021
• Primary Completion: July 10, 2022
• Study Completion: July 10, 2022
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)