Trial Outcomes & Findings for Resin Infiltration to Arrest Early Tooth Decay (NCT NCT01584024)

NCT ID: NCT01584024

Last Updated: 2019-02-12

Results Overview

Cumulative lesion progression as measured by PW comparison of radiographs (baseline versus 3 year)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 42 participants
• Primary outcome timeframe: 3 Years
• Results posted on: 2019-02-12

Participant Flow

Caries-active volunteer cadet-candidates and cadets, at high risk for caries disease, were recruited at United States Military Academy in West-Point, New York (USA).

Paired, split-mouth study design: Each patient received 2 paired treatments (one of each arm). Eligible tooth pairs were selected for similarity. Random allocation of treatment to study lesions per tooth pair.

Unit of analysis: Lesions

Participant milestones

Measure	Participants With Paired Lesions: Resin Infiltration / Control Within-person study: both arms were applied in same participant (2 study teeth/lesions per person). Resin infiltration (test) or Sham Treatment (control) of two paired carious lesions in addition to preventative measures and behavioral modification.
Overall Study STARTED	42 84
Overall Study COMPLETED	29 58
Overall Study NOT COMPLETED	13 26

Reasons for withdrawal

Measure	Participants With Paired Lesions: Resin Infiltration / Control Within-person study: both arms were applied in same participant (2 study teeth/lesions per person). Resin infiltration (test) or Sham Treatment (control) of two paired carious lesions in addition to preventative measures and behavioral modification.
Overall Study Lost to Follow-up	10
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Resin Infiltration to Arrest Early Tooth Decay

Baseline characteristics by cohort

Measure	Participants With Paired Lesions: Resin Infiltration / Control n=84 Lesions Within-person study: both arms were applied in same participant (2 study teeth/lesions per person).
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	20.1 years STANDARD_DEVIATION 0.9 • n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	40 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=93 Participants
Race (NIH/OMB) Black or African American	11 Participants n=93 Participants
Race (NIH/OMB) White	28 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	42 Participants n=93 Participants
Number of Lesions with Progression	58 Lesions n=30 Lesions

PRIMARY outcome

Timeframe: 3 Years

Cumulative lesion progression as measured by PW comparison of radiographs (baseline versus 3 year)

Outcome measures

Measure	Resin Infiltration n=29 Lesions Resin infiltration of lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish)	Control n=29 Lesions Sham treatment of lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish)
Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions)	4 Lesions	14 Lesions

SECONDARY outcome

Timeframe: 3 Years

Radiographic lesion depth categories: E2 (inner enamel), D1 (outer dentin) and D2-rest (middle dentin or restored). Lesion depth assessment on single radiograph (baseline, 3 yr).

Outcome measures

Measure	Resin Infiltration n=29 Lesions Resin infiltration of lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish)	Control n=29 Lesions Sham treatment of lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish)
Number of Lesions With Progression as Measured by Depth Category (N=Lesions)	3 Lesions	7 Lesions

Adverse Events

Participants With Paired Lesions: Resin Infiltration / Control

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 Peters (PI)

University of Michigan

Phone: 734-925-2750

Email: mcpete@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place