Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.

Phase 2

Completed

• Conditions: Dental Plaque; Side Effects
• Interventions: Drug: 0.12%NF; Drug: 0.03%NF; Drug: PAT

• Registration Number: NCT02194023
• Lead Sponsor: Universitat Internacional de Catalunya

Brief Summary

In the current study we tested the hypothesis that new 0.05% Cetylpyridinium chloride (CPC) mouthrinse formulations containing 0.12% or 0.03% chlorhexidine digluconate (CHX): 1) yield similar or better clinical results regarding the inhibition of de novo plaque growth compared to those achieved with an already marketed 0.12% CHX mouthrinse (Perio-Aid Treatment without alcohol. Dentaid, Spain), 2) reduce the side effects caused by the marketed 0.12% CHX formula and 3) that these mouthrinses have no negative microbiological effects, and they control total bacterial loads.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-07
• Study First Submitted: 2014-07-13
• Study First Submitted QC: 2014-07-17
• Last Update Submitted: 2014-07-17
• Study First Posted: 2014-07-18
• Last Update Posted: 2014-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 18-30 years
• Good overall health without medical history or medications that could interfere with the study conduct.
• Minimum of 6 teeth per quadrant.
• Absence of probing depths ≥4mm.

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Exclusion Criteria

• Allergy to CHX or to CPC.
• Continuous use of CHX or of any other oral antiseptic in the months prior to the study.
• Any adverse medical background or long-term medications that could affect gingival conditions.
• Having taken antibiotics in the previous three months.
• Moderate to severe gingivitis (bleeding on probing ≥ 40%). 41(Van der Weijden et al. 1994).
• Pregnancy or breastfeeding.
• Smokers of more than 5 cigarettes per day.
• Orthodontic appliances.
• Fixed or removable prostheses.
• Systemic diseases that increase the risk for gingival diseases (diabetes mellitus, immunosuppression).
• Severe dental crowding.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.12%NF	0.12%NF	0.12% Chlorhexidine digluconate new formulation
0.03%NF	0.03%NF	0.03% Chlorhexidine digluconate new formulation
PAT (Perio-Aid Treatment)	PAT	Commercialized 0.12% Clorhexidine digluconate (Perio-Aid Treatment, Dentaid, Spain)

Primary Outcome Measures

Name	Time	Method
Percentage of participants with greater reduction of plaque regrowth and side effects.	Baseline to 4 days.

Trial Locations

Locations (1)

UIC dental office, Hospital General de Catalunya; 🇪🇸 Sant Cugat, Barcelona, Spain