Trial Outcomes & Findings for Clinical Trial Proximal Caries Infiltration and Detection (NCT NCT01796106)

Last Updated: 2023-07-19

Results Overview

Change in categorical lesion depth (progression to next depth category lesion; E1-\>E2-\>D1-\>D2-\>filling) as measured by pairwise comparison of radiographs (baseline versus follow up time point). E1 (lesion within the outer half of enamel), E2 (inner half of enamel), D1 (outer third of dentin), D2 (middle third of dentin).

Recruitment status

TERMINATED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

24 months

Results posted on

2023-07-19

Participant Flow

Subjects were recruited from patients seeking treatment at the Center for Pediatric Dentistry Seattle, Washington, USA. The first participant was enrolled in March 2015 and the last was enrolled in March 2016.

Up to two proximal early caries lesions per participant were included, but only if the second lesion was located in a separate quadrant.

Unit of analysis: Lesions

Participant milestones

Participant milestones
Measure	Resin Infiltration After radiographic and scanning fiber endoscope (SFE) imaging to assess lesion depth, the study lesions were treated using the resin infiltrant Icon (DMG, Germany) according to manufactures´ instructions.	Fluoride Varnish & Oral Hygiene Instruction After radiographic and scanning fiber endoscope (SFE) imaging to assess lesion depth oral hygiene instruction and topical fluoridation therapy were provided. For topical fluoridation Duraphat Fluoride Varnish (Colgate, USA) has been used according to manufactures´ instructions.
Overall Study STARTED	5 5	7 7
Overall Study 12 Months Follow up	0 0	0 0
Overall Study COMPLETED	0 0	0 0
Overall Study NOT COMPLETED	5 5	7 7

Reasons for withdrawal

Reasons for withdrawal
Measure	Resin Infiltration After radiographic and scanning fiber endoscope (SFE) imaging to assess lesion depth, the study lesions were treated using the resin infiltrant Icon (DMG, Germany) according to manufactures´ instructions.	Fluoride Varnish & Oral Hygiene Instruction After radiographic and scanning fiber endoscope (SFE) imaging to assess lesion depth oral hygiene instruction and topical fluoridation therapy were provided. For topical fluoridation Duraphat Fluoride Varnish (Colgate, USA) has been used according to manufactures´ instructions.
Overall Study Study was terminated due to insufficient recruitment before follow ups could be completed	5	7

Baseline Characteristics

Clinical Trial Proximal Caries Infiltration and Detection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Resin Infiltration n=5 Lesions After radiographic and SFE imaging to assess lesion depth, the study lesions were treated using the resin infiltrant Icon (DMG, Germany) according to manufactures´ instructions.	Fluoride Varnish & Oral Hygiene Instruction n=7 Lesions After radiographic and SFE imaging to assess lesion depth oral hygiene instruction and topical fluoridation therapy were provided. For topical fluoridation Duraphat Fluoride Varnish (Colgate, USA) has been used according to manufactures´ instructions.	Total n=12 Lesions Total of all reporting groups
Age, Categorical <=18 years	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Unknown	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Lesion size E1	2 Lesions n=30 Lesions	3 Lesions n=7 Lesions	5 Lesions n=12 Lesions
Lesion size E2	2 Lesions n=30 Lesions	4 Lesions n=7 Lesions	6 Lesions n=12 Lesions
Lesion size D1	1 Lesions n=30 Lesions	0 Lesions n=7 Lesions	1 Lesions n=12 Lesions
Lesion size D2	0 Lesions n=30 Lesions	0 Lesions n=7 Lesions	0 Lesions n=12 Lesions

PRIMARY outcome

Timeframe: 24 months

Population: This study was terminated due to insufficient recruitment. The 24 month follow up was not reached for any enrolled participant at the time of termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 12 and 24 months

Population: This study was terminated due to insufficient recruitment. Only 12 (out 50 planned) participants could be recruited and the 12 and 24 month follow ups were not reached for any enrolled participant at the time of termination.

Categorical lesion depth (E1, E2, D1, D2) is measured using SFE imaging. The results are compared to the assessment of categorical lesion depth using radiographic imaging (state of the art method). Outcomes are defined as follows: 1) positive (if SFE imaging gave the same result as the radiograph analysis), 2) negative (if SFE imaging gave a different result as the radiograph analysis) and 3) failure (if lesion depth could not be assessed using SFE imaging). Categorical lesion depth: E1 (lesion within the outer half of enamel), E2 (inner half of enamel), D1 (outer third of dentin), D2 (middle third of dentin).

Outcome measures

Outcome measures
Measure	Resin Infiltration n=5 Lesions After radiographic and SFE imaging to assess lesion depth, the study lesions were treated using the resin infiltrant Icon (DMG, Germany) according to manufactures´ instructions.	Fluoride Varnish & Oral Hygiene Instruction n=7 Lesions After radiographic and SFE imaging to assess lesion depth oral hygiene instruction and topical fluoridation therapy were provided. For topical fluoridation Duraphat Fluoride Varnish (Colgate, USA) has been used according to manufactures´ instructions.
Validation of SFE Imaging for Lesion Size Assessment: SFE Imaging vs. Radiographic Imaging Baseline · Positive	1 Lesions	2 Lesions
Validation of SFE Imaging for Lesion Size Assessment: SFE Imaging vs. Radiographic Imaging Baseline · Negative	1 Lesions	2 Lesions
Validation of SFE Imaging for Lesion Size Assessment: SFE Imaging vs. Radiographic Imaging Baseline · Failure	3 Lesions	3 Lesions
Validation of SFE Imaging for Lesion Size Assessment: SFE Imaging vs. Radiographic Imaging 12 months · Positive	0 Lesions	0 Lesions
Validation of SFE Imaging for Lesion Size Assessment: SFE Imaging vs. Radiographic Imaging 12 months · Negative	0 Lesions	0 Lesions
Validation of SFE Imaging for Lesion Size Assessment: SFE Imaging vs. Radiographic Imaging 12 months · Failure	0 Lesions	0 Lesions
Validation of SFE Imaging for Lesion Size Assessment: SFE Imaging vs. Radiographic Imaging 24 months · Positive	0 Lesions	0 Lesions
Validation of SFE Imaging for Lesion Size Assessment: SFE Imaging vs. Radiographic Imaging 24 months · Negative	0 Lesions	0 Lesions
Validation of SFE Imaging for Lesion Size Assessment: SFE Imaging vs. Radiographic Imaging 24 months · Failure	0 Lesions	0 Lesions

SECONDARY outcome

Timeframe: 12 months

Population: This study was terminated due to insufficient recruitment. The 12 month follow up was not reached for any enrolled participant at the time of termination.

Outcome measures

Outcome data not reported

Adverse Events

Resin Infiltration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fluoride Varnish & Oral Hygiene Instruction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager Clinical Research

DMG Dental Material Gesellschaft mbH

Phone: 04084006

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60