N/A N=30 Other

Caries Lesion Activity in Orthodontic Patients - Calcivis System

Dental Caries

Bottom Line

View on ClinicalTrials.gov: NCT02771522 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Presence or Absence of Elevated Luminescence — 61.7; 17.3; 6.0; 10.2 % active teeth with luminescence

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Calcivis System (Device)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Calcivis Ltd
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Presence or Absence of Elevated Luminescence	58.9; 11.4; 2.6; 6.3; 8.3; 100.0	—
PRIMARY Presence or Absence of Elevated Luminescence	58.9; 11.4; 2.6; 6.3; 8.3; 100.0	—
SECONDARY Number of Non-patient Related Adverse Events With the Calcivis System	3	—
SECONDARY Patient Experience	16; 2; 0; 18; 0; 0	—
SECONDARY Patient Experience	16; 2; 0; 18; 0; 0	—
SECONDARY User Questionnaires	21; 9; 0; 17; 11; 2	—

Summary

This is a prospective, single-centre clinical study to monitor caries lesion activity in orthodontic patients with the Calcivis System over a 12 week period. Dentists will identify patients who have had dental appliances in place for a minimum of 12 months and have visible white spot lesions on the anterior surfaces of incisors and / or canines at de-bond. Following de-bond, images of the tooth surface will be taken with the Calcivis System. Presence or absence of elevated luminescence on the images will indicate activity / inactivity. Only patients with at least one tooth identified as active with the Calcivis System will continue in the study and be followed up at 2, 4, 8 and 12 weeks de-bond. Images of the active teeth will be taken with the Calcivis System as before, at each follow-up visit. The percentage of teeth showing luminescence using the Calcivis System will be calculated and summarised for all subjects for each post-baseline visit, and additionally by Investigator. This will then be summarised over all subjects for each post-baseline visit.

Eligibility Criteria

Inclusion Criteria

Patient must be ≥ 12 years old
Patient must have had orthodontic appliances placed on the upper incisors and / or canines for at least 12 months, and be ready for de-bond
Patient must have at least one, active white spot lesion identified by the Calcivs System immediately post de-bond
Patient and / or parent or guardian must be willing and able to give written informed consent
Patient and / or parent or guardian must be willing and able to adhere to study schedule

Exclusion Criteria

Any Patient with recent tooth bleaching (within previous two weeks of imaging with the Calcivis System) or within the follow-up period
Any patient currently taking part in a clinical research study, or who has taken part in a clinical research study in the previous three months
Pregnant and / or nursing mothers

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02771522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.