Phase IV Open-label Pharmaco-economic and Practice Management Study of a New Preventive Treatment for Adult Caries in the U.K. and Germany - PPMS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006104-11-GB

Enrollment

125

Registered

2007-01-07

Start date

2008-12-23

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult dental caries

Interventions

Trade Name: Prevora Stage 1 Product Name: Prevora Stage 1 Pharmaceutical Form: Dental solution CAS Number: 56-95-1 Other descriptive nam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 40 years of age and older - dentate in both arches - at risk of dnetal caries in the future by way of clinical judgement of the dentist on the basis of the following risk factors: - history of caries in the past 2 years requiring active treatment (restoration/lesion specific prevention) - AND one of: - gum recession of 1 mm or greater on any tooth - limited salivary flow - multiple medication use - ongoing periodontal disease - removable partial denture wearer - willing and able to provide informed consent - a practice patient registered under private arrangements - not participating in another study - women with childbearing potential if using an effective method of contraception during the course of the trial (as defined by EMEA, CMPM/ICH/286/95) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - pregnant or planning to become pregnant in the next 12 months - nursing mother - allergic to any of the ingredients of Prevora Stage 1 (chlorhexidine diacetate, Sumatra benzoin, alcohol) and Prevora Sealant Stage 2 (ammonio methacrylate copolymer Type B, triethyl citrate) - patients who received in the last 3 days before study treatment any fluoride gel or directly before treatment any oil based prophylactic - investigator discretion that the participant will not complete the study's activities - participating in another study

Design outcomes

Primary

Measure	Time frame
Main Objective: To identify benefit-costs of treatment in a primary dental care setting; Secondary Objective: To identify daily clinical need in a primary dental care setting. To identify cost of applying Prevora Stage 1 in various primary dental care settings. To identify willingness to pay for treatment. ;Primary end point(s): The primary endpoint is a benefit-cost assessment of a new preventive treatment for older adults at risk of dental caries within the setting of primary dental care clinics. Secondary endpoints are daily clinical need, cost of providing this treatment and willingness to pay.	—

Measure

Time frame

Main Objective: To identify benefit-costs of treatment in a primary dental care setting; Secondary Objective: To identify daily clinical need in a primary dental care setting. To identify cost of applying Prevora Stage 1 in various primary dental care settings. To identify willingness to pay for treatment. ;Primary end point(s): The primary endpoint is a benefit-cost assessment of a new preventive treatment for older adults at risk of dental caries within the setting of primary dental care clinics. Secondary endpoints are daily clinical need, cost of providing this treatment and willingness to pay.

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Countries

Germany, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026