Trial Outcomes & Findings for Radiographic Progression of Infiltrated Caries Lesions In-vivo (NCT NCT01496456)

Last Updated: 2017-08-08

Results Overview

Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).

Recruitment status

COMPLETED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

Baseline through 3 years

Results posted on

2017-08-08

Participant Flow

Recruitment was not as expected and halted after one year. Local options to enhance patient accrual were exhausted. The total patient pool was small, but of sufficient scientific value to continue and complete the study.

Paired, split-mouth study design: Each patient received at least 1 pair of 2 treatments (one of each arm). Eligible tooth pairs selected for similarity. Random allocation of treatment to study teeth of each tooth pair.

Participant milestones

Participant milestones
Measure	Lesion Infiltration and Preventative Management Only Paired split-mouth study: both arms (arm A and arm B) were applied in same patient (2 study teeth). A) Resin infiltration therapy in addition to SOC Preventative caries management B) SOC Preventative caries management only. \--- Standard Of Care (SOC) Baseline preventative caries management included dietary and behavioral modification, and over-the-counter (OTC) fluoride supplements.
Overall Study STARTED	17
Overall Study Baseline	16
Overall Study 1-yr Recall	12
Overall Study 2-yr Recall	10
Overall Study 3-yr Final Recall	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Lesion Infiltration and Preventative Management Only Paired split-mouth study: both arms (arm A and arm B) were applied in same patient (2 study teeth). A) Resin infiltration therapy in addition to SOC Preventative caries management B) SOC Preventative caries management only. \--- Standard Of Care (SOC) Baseline preventative caries management included dietary and behavioral modification, and over-the-counter (OTC) fluoride supplements.
Overall Study Protocol Violation	1
Overall Study Lost to Follow-up	7

Baseline Characteristics

Radiographic Progression of Infiltrated Caries Lesions In-vivo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lesion Infiltration and Preventative Management Only n=16 Participants Paired split-mouth study: both arms in same patient (2 study teeth). A) Resin infiltration therapy in addition to preventative caries management B) Preventative caries management only SOC Baseline preventative caries management: dietary and behavioral modification, and OTC fluoride supplements
Age, Categorical <=18 years	8 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	21.1 years STANDARD_DEVIATION 7.1 • n=99 Participants
Sex: Female, Male Female	12 Participants n=99 Participants
Sex: Female, Male Male	4 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants
Race (NIH/OMB) White	12 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	16 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline through 3 years

Population: Pairwise assessment: visual (PWA) + digital subtraction radiography (DSR).

Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).

Outcome measures

Outcome measures
Measure	Lesion Infiltration n=13 Lesions Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.	Preventative Measures n=13 Lesions SOC Caries management by preventative measures only.
Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)	2 Lesions	11 Lesions

SECONDARY outcome

Timeframe: Baseline through 3 years

Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA).

Outcome measures

Outcome measures
Measure	Lesion Infiltration n=13 Lesions Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.	Preventative Measures n=13 Lesions SOC Caries management by preventative measures only.
Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories	2 Lesions	9 Lesions

SECONDARY outcome

Timeframe: 3 years

Population: Radiographic lesion increase by PWA+DSR. A tooth was included up until the time the lesion first increased.

Discrete time survival analysis of time to first lesion progression.

Outcome measures

Outcome measures
Measure	Lesion Infiltration n=18 Lesions Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.	Preventative Measures n=18 Lesions SOC Caries management by preventative measures only.
Lesion Survival After 3 Years	11 Lesions	3 Lesions

Adverse Events

Lesion Infiltration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Preventative Measures

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

Dr. Mathilde C Peters

UMichigan

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place