Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization

Tooth Decay Clinical Trial

Official title:

Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780270
• Other study ID #: 500
• Status: Completed
• Phase: N/A
• Start date: June 16, 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: December 2018
• Source: University Dentistry Clinical Center of Kosovo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate

1. the additional therapeutic benefit of Curodont Repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone

2. the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride varnish

Description:

Objectives: The purpose of this study is to evaluate

1. the additional therapeutic benefit of Curodont Repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone

2. the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride varnish

Methods: 90 patients with early occlusal lesions (ICDAS-II:2-3) on permanent molars and pre-molars will be allocated in this randomized, controlled, single blinded study to one of the two test groups (Test1: Curodont™ Repair+Fluoride Varnish; Test2: Curodont Repair+Curodont Protect) or control (Fluoride Varnish) group.

Lesions will be assessed at baseline and recalls after 3, 6 and 12 months regarding caries activity (Nyvad), clinical status (ICDAS-II) and with Diagnodent®. Visual Analog Scale (VAS) in addition to the Global Impression of Change Questionnaire will also be used for the evaluation of the outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

Inclusion Criteria:

• Early occlusal carious lesion which does not require an invasive treatment (ICDAS-II scores: 2 and 3)

• Size and form of the lesion: the lesion must both be fully visible and assessable and accessible

• Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study

• Written informed consent before participation in the study

Exclusion Criteria:

• Evidence of tooth Erosion

• Fluoride varnish application < 3 months prior to study treatment

• History of head and neck illnesses (e.g. head/neck cancer)

• Any pathology or concomitant medication affecting salivary flow or dry mouth

• Any metabolic disorders affecting bone turnover

• Concurrent participation in another clinical trial

Related Conditions & MeSH terms

• Dental Caries
• Tooth Decay

Intervention

Device:
• Fluoride Varnish
Fluor Protector S (Ivoclar, 7'700 ppm F-)
• Curodont Repair
P11-4 (monomeric peptide) - for professional use
• Curodont Protect
Tooth gel (containing P11-4 assembled to a fibrillary matrix) - for home use (OTC)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Dentistry Clinical Center of Kosovo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group	Diagnodent values for fissure caries: 0-5: no demineralization, sound. 6-14: outer enamel demineralization. 15-20: inner enamel demineralization. 21-99: dentine demineralization.	Day 180
Secondary	Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group	Diagnodent values for fissure caries: 0-5: no demineralization, sound. 6-14: outer enamel demineralization. 15-20: inner enamel demineralization. 21-99: dentine demineralization.	Day 90 and Day 360
Secondary	Frequency of change in ICDAS-II (International caries detection and assessment system) codes for each study group	Code 0: Sound tooth surface, no evidence of caries after prolonged air drying (5 sec).; Code 1: First visual change in enamel. Code 2: Distinct visual change in enamel. Code 3: Localized enamel breakdown due to caries with no visible dentine or underlying shadow.; Code 4: Underlying dark shadow from dentine with or without enamel breakdown. Code 5: Distinct cavity with visible dentine. Code 6: Extensive distinct cavity with visible dentine (involving more than half of the dentine).	Day 90, Day 180, Day 360
Secondary	Frequency of change in caries lesion activity and severity assessed by Nyvad criteria for each study group	Score 0: Sound. Score 1: Active caries - intact surface. Score 2: Active caries - surface discontinuity. Score 3: Active caries - cavity. Score 4: Inactive caries - intact surface. Score 5: Inactive caries - surface discontinuity. Score 6: Inactive caries - cavity.	Day 90, Day 180, Day 360
Secondary	Mean of VAS values (Visual analogue scale) for each study group	Range: from -50 (strongly remineralizing) to +50 (stronlgy progressing)	Day 90, Day 180, Day 360
Secondary	Frequency of Evaluation Outcome of Global Impression of Change Questionnaire for each study group	Investigator Questionnaire: evaluation ranging from "very much worse" to "very much better"; 7-point scale	Day 90, Day 180, Day 360