6-month Clinical Investigation Assessing the Efficacy of an Antimicrobial Mouthrinse in Reducing Established Plaque and Improving Gum Health

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorColgate Palmolive

About this trial

The goal of this clinical trial is to evaluate the clinical efficacy of an antimicrobial mouthrinse, with a particular focus on its effect on established plaque and the improvement of gum health.

Participants will:

* Brush and rinse twice a day with the designated products for 6 months * Visit the clinic once every 3 months after baseline for reassessment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male and female subjects aged 18-70 years, inclusive.

Availability for the 6-month duration of the clinical research study.

Good general health based on the opinion of the study investigator.

Signed Informed Consent Form.

Disqualifiers

Be under orthodontic treatment.

Presence of partial removable dentures.

Tumor(s) of the soft or hard tissues of the oral cavity.

Participants with current moderate or severe periodontitis (periodontitis screening index [PSI] >2 in more than 2 sextants or PSI >3), and/or purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Test Mouthrinse

    Other intervention

    Test Mouthrinse: 0.0553% NaF (250 ppm Fluoride), Amine and 0.2% Zinc Lactate dihydrate

  • Control Mouthrinse

    Other intervention

    Control Mouthrinse: 0.0553% NaF(250 ppm Fluoride)

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Test GroupActive comparator 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Improvement of gum health as measured by the Gingival Index (Löe 1967) between the study groups.

Four areas of the tooth (buccal, lingual, mesial, and distal surfaces) will be assessed. Each site is assigned a score from 0 to 3 based on clinical observation: 0 indicates normal gingiva and 3 denotes severe inflammation with marked redness, edema, ulceration, and a tendency toward spontaneous bleeding.

Time frame
6-month period

Secondary outcomes

1

Plaque scores as measured by the Plaque Index (Turesky et al. 1970) between the study groups

The index will quantify dental plaque accumulation by assessing the facial and lingual surfaces of all teeth, typically excluding third molars. Using a disclosing solution to make the bacterial biofilm visible, the examiner will assign a score from 0 to 5 to each surface based on the extent of coverage: 0 indicates no plaque and 5 indicates plaque covering more than two-thirds of the tooth surface.

Time frame
6-month period

Other outcomes

Sponsors and contacts

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