Trial Outcomes & Findings for Caries Lesion Activity in Orthodontic Patients

Results Overview

Percentage of active teeth showing luminescence (as measured by Calcivis System imaging) over time

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

0, 2, 4, 8 and 12 weeks

Results posted on

2019-02-28

Participant Flow

Patients were recruited by two Investigators from a routine NHS Orthodontic clinic between 15 February 2017 and 01 May 2018. Of the 36 patients attending Visit 1, 30 were eligible for Calcivis imaging ( 3 patients were pregnant, 2 patients had appliances on less than 12 months and I patient did not have visible white spot lesions).

Unit of analysis: Teeth

Participant milestones

Participant milestones
Measure	Active Post-othodontic Lesions Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis imaging system, active teeth were again imaged at 2, 4, 8 and 12 weeks. Black \& white and luminescent images of the teeth were taken. The images of each tooth were overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)
Overall Study STARTED	30 119
Overall Study COMPLETED	22 87
Overall Study NOT COMPLETED	8 32

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Post-othodontic Lesions Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis imaging system, active teeth were again imaged at 2, 4, 8 and 12 weeks. Black \& white and luminescent images of the teeth were taken. The images of each tooth were overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	2
Overall Study No white spot lesions	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Post-othodontic Lesions n=30 Participants Imaging with the Calcivis System: Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis imaging system, each active tooth was again be imaged at 2, 4, 8 and 12 weeks. In order to improve study recruitment, a Protocol Amendment was approved to reduce the overall number of visits to 2, 4 and 8 weeks, however there is data available form all time points. The images of the teeth are taken immediately before and after application of a small amount of solution. The images of each tooth are overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)
Age, Continuous	19.9 years STANDARD_DEVIATION 6.52 • n=30 Participants
Sex: Female, Male Female	16 Participants n=30 Participants
Sex: Female, Male Male	14 Participants n=30 Participants
Region of Enrollment United Kingdom	30 participants n=30 Participants
Number of teeth imaged and deemed active	73 Teeth n=30 Participants

PRIMARY outcome

Timeframe: 0, 2, 4, 8 and 12 weeks

Population: From 30 participants a total of 119 teeth were imaged at baseline then different numbers of patients attended different follow-up visits

Percentage of active teeth showing luminescence (as measured by Calcivis System imaging) over time

Outcome measures

Outcome measures
Measure	Active Post-othodontic Lesions n=119 Teeth Imaging with the Calcivis System - Percentage teeth with luminescence over time
Presence or Absence of Elevated Luminescence Baseline	61.7 % active teeth with luminescence
Presence or Absence of Elevated Luminescence 2 weeks post de-bond	17.3 % active teeth with luminescence
Presence or Absence of Elevated Luminescence 4 weeks post de-bond	6.0 % active teeth with luminescence
Presence or Absence of Elevated Luminescence 8 weeks post de-bond	10.2 % active teeth with luminescence
Presence or Absence of Elevated Luminescence 12 weeks post de-bond	6.3 % active teeth with luminescence

PRIMARY outcome

Timeframe: 0, 2, 4, 8 and 12 weeks post de-bond

Population: From a total of 30 participants (28 patients from Investigator 1, and 2 patients from Investigator 2) a total of 119 teeth were imaged at baseline then different numbers of patients attended different follow-up visits

Percentage of active teeth showing luminescence (as measured by Calcivis System imaging) over time, per Investigator

Outcome measures

Outcome measures
Measure	Active Post-othodontic Lesions n=119 Teeth Imaging with the Calcivis System - Percentage teeth with luminescence over time
Presence or Absence of Elevated Luminescence Site 11 - Baseline	58.9 % active teeth with luminescence
Presence or Absence of Elevated Luminescence Site 11 - 2 weeks post de-bond	11.4 % active teeth with luminescence
Presence or Absence of Elevated Luminescence Site 11 - 4 weeks post de-bond	2.6 % active teeth with luminescence
Presence or Absence of Elevated Luminescence Site 11 - 8 weeks post de-bond	6.3 % active teeth with luminescence
Presence or Absence of Elevated Luminescence Site 11 - 12 weeks posar de-bond	8.3 % active teeth with luminescence
Presence or Absence of Elevated Luminescence Site 31 - Baseline	100.0 % active teeth with luminescence
Presence or Absence of Elevated Luminescence Site 31 - 2 weeks post debond	50.0 % active teeth with luminescence
Presence or Absence of Elevated Luminescence Site 31 - 4 weeks posat de-bond	37.5 % active teeth with luminescence
Presence or Absence of Elevated Luminescence Site 31 - 8 weeks post de-bond	50.0 % active teeth with luminescence
Presence or Absence of Elevated Luminescence Site 31 - 12 weeks post de-bond	0.0 % active teeth with luminescence

SECONDARY outcome

Timeframe: 0 days, 2, 4, 8 and 12 weeks

Population: All patients imaged with the Calcivis System

All adverse events and device deficiencies were collected throughout the study on Adverse Event Forms

Outcome measures

Outcome measures
Measure	Active Post-othodontic Lesions n=30 Participants Imaging with the Calcivis System - Percentage teeth with luminescence over time
Number of Non-patient Related Adverse Events With the Calcivis System	3 Non-patient-related Adverse Events

SECONDARY outcome

Timeframe: Baseline

Population: Patient Questionnaires comprised of two questions and patients were asked to tick the most appropriate response on a three-point scale

Completion of Patient Questionnaires after imaging with the Calcivis System

Outcome measures

Outcome measures
Measure	Active Post-othodontic Lesions n=30 Participants Imaging with the Calcivis System - Percentage teeth with luminescence over time
Patient Experience Calcivis System experience:good	27 participants
Patient Experience Calcivis System experience:neither good nor bad	3 participants
Patient Experience Calcivis System experience:bad	0 participants
Patient Experience Calcivis System - seeing images:helpful	30 participants
Patient Experience CalcivisSystem-images-neither good nor bad	0 participants
Patient Experience CalcivisSystem - seeing images - bad	0 participants

SECONDARY outcome

Timeframe: Final Visit - either 8 or 12 weeks post debond

Population: Patient Questionnaires comprised two questions and patients asked to tick the most appropriate response on a three-point scale

Completion of Patient Questionnaires after imaging with the Calcivis System at patient's final visit

Outcome measures

Outcome measures
Measure	Active Post-othodontic Lesions n=18 Participants Imaging with the Calcivis System - Percentage teeth with luminescence over time
Patient Experience Calcivis System experienc: good	16 Participants
Patient Experience Calcivis System experience: neither good nor bad	2 Participants
Patient Experience Calcivis System experience: bad	0 Participants
Patient Experience Calcivis System-seeing images: helpful	18 Participants
Patient Experience CalcivisSystem images:neitherhelpfuln	0 Participants
Patient Experience Calcivis System - seeing images: unhelpful	0 Participants

SECONDARY outcome

Timeframe: Baseline visit

Population: User Questionnaires were completed by the dentist and nurse at the end of every imaging session about their experiences using the Calcivis System. They were asked to tick the most appropriate response on a three-point scale e.g. easy, neither easy nor difficult , difficult.

Completion of User Questionnaires after imaging with the Calcivis System

Outcome measures

Outcome measures
Measure	Active Post-othodontic Lesions n=30 Questionnaires Imaging with the Calcivis System - Percentage teeth with luminescence over time
User Questionnaires Calcivis System preparation:easy	21 User Questionniares
User Questionnaires CalcivisSystempreparation:neithereasynordifficult	9 User Questionniares
User Questionnaires Calcivis system preparation: difficult	0 User Questionniares
User Questionnaires Calcivis System use: easy	17 User Questionniares
User Questionnaires Calcivis System use: neither easy nor difficult	11 User Questionniares
User Questionnaires calcivis System use: difficult	2 User Questionniares
User Questionnaires Calcivis System experience: good	24 User Questionniares
User Questionnaires Calcivis System experience:neither good nor bad	4 User Questionniares
User Questionnaires Calcivis System experience: bad	2 User Questionniares
User Questionnaires Understand instructions:easy	19 User Questionniares
User Questionnaires Understand instructions:neither easy nor difficult	11 User Questionniares
User Questionnaires Understand instructions: difficult	0 User Questionniares

Adverse Events

Active Post-othodontic Lesions

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active Post-othodontic Lesions n=30 participants at risk Imaging with the Calcivis System: Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis System, each active tooth will be again be imaged at 2, 4, 8 and 12 weeks. The images of the teeth are taken immediately before and after application of a small amount of disclosing solution. The images of each tooth are overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)
Product Issues non patient related adverse events	10.0% 3/30 • Number of events 3 • 12 weeks post baseline visit All adverse events and device deficiencies were collected throughout the study on Adverse Event Forms

Additional Information

Director of Clinical Research

Calcivis Ltd

Phone: +44 131 658 5152

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place