Trial Outcomes & Findings for Lesion Progression After Icon Treatment in Young Adults (NCT NCT01988337)

NCT ID: NCT01988337

Last Updated: 2022-10-04

Results Overview

Cumulative number of study lesions that have progressed to a state were an invasive intervention (filling) has been required to restore the teeth as determined via an dental examination (baseline versus 3 year follow up).

Recruitment status

TERMINATED

Study phase

Target enrollment

56 participants

Primary outcome timeframe

3 years

Results posted on

2022-10-04

Participant Flow

Subjects were recruited from patients seeking treatment at the University of Alabama at Birmingham, School of Dentistry, USA, and through advertisements. The first participant was enrolled in August 2015 and the last was enrolled in August 2017.

Within-person study (split-mouth design): Per participant at least one lesion pair (two lesions on seperate teeth) were included. These two lesions were randomly allocated to either treatment (resin infiltration) or control (mock treatment) group resulting in paired lesions within the participants. For some participants more than one lesion pair was included.

Unit of analysis: Lesions

Participant milestones

Participant milestones
Measure	Resin Infiltration / Mock Treatment (Split-mouth; Participants With Paired Lesions) Within-person study (split-mouth design): For each participant at least one pair of lesions has been included, with one lesion per pair having been randomized to the treatment group (resin infiltration) and the other to the control group (mock treatment). Resin infiltration or Mock treatment was performed at baseline (study start) according to manufacturers' instructions for the respective study lesion; in addition to general caries preventive measures (standard-oral care hygiene treatment, diet counselling and fluoride regimen).
Overall Study STARTED	56 130
Overall Study Intervention (at Baseline)	56 130
Overall Study 6 Months Follow up	43 102
Overall Study 12 Months Follow up	43 102
Overall Study COMPLETED	0 0
Overall Study NOT COMPLETED	56 130

Reasons for withdrawal

Reasons for withdrawal
Measure	Resin Infiltration / Mock Treatment (Split-mouth; Participants With Paired Lesions) Within-person study (split-mouth design): For each participant at least one pair of lesions has been included, with one lesion per pair having been randomized to the treatment group (resin infiltration) and the other to the control group (mock treatment). Resin infiltration or Mock treatment was performed at baseline (study start) according to manufacturers' instructions for the respective study lesion; in addition to general caries preventive measures (standard-oral care hygiene treatment, diet counselling and fluoride regimen).
Overall Study Study was terminated due to insufficient recruitment before 36 month follow up could be completed	56

Baseline Characteristics

In this within-person study (split-mouth design), at least one pair of lesions has been included per participant, with one lesion per pair being allocated to the treatment group (resin infiltration) and the other to the control group (mock treatment). Consequently, half of all study lesions belong to the treatment group and half to control group.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Resin Infiltration / Mock Treatment (Split-mouth; Participants With Paired Lesions) n=130 Lesions Within-person study (split-mouth design): For each participant at least one pair of lesions has been included, whereas one lesion per pair was randomized to the treatment group (resin infiltration) and the other to the control group (mock treatment). Resin infiltration or Mock treatment was performed at baseline (study start) according to manufacturers' instructions for the respective study lesion; in addition to general caries preventive measures (standard-oral care hygiene treatment, diet counselling and fluoride regimen).
Age, Categorical <=18 years	13 Participants n=56 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=56 Participants
Age, Categorical >=65 years	0 Participants n=56 Participants
Age, Continuous	30 years n=56 Participants
Sex: Female, Male Female	40 Participants n=56 Participants
Sex: Female, Male Male	16 Participants n=56 Participants
Race/Ethnicity, Customized Caucasian	32 Participants n=56 Participants
Race/Ethnicity, Customized Asian	1 Participants n=56 Participants
Race/Ethnicity, Customized African American	19 Participants n=56 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=56 Participants
Race/Ethnicity, Customized Two ethnicities (Asian and Hispanic)	1 Participants n=56 Participants
Region of Enrollment United States	56 participants n=56 Participants
Caries Risk (CR) Low Caries Risk (CR<33%)	17 Participants n=56 Participants
Caries Risk (CR) Moderate Caries Risk (34%<CR<66%)	39 Participants n=56 Participants
Caries Risk (CR) High Caries Risk (67%<CR)	0 Participants n=56 Participants
Lesion size Resin infiltration group · E1	40 Lesions n=65 Lesions • In this within-person study (split-mouth design), at least one pair of lesions has been included per participant, with one lesion per pair being allocated to the treatment group (resin infiltration) and the other to the control group (mock treatment). Consequently, half of all study lesions belong to the treatment group and half to control group.
Lesion size Resin infiltration group · E2	13 Lesions n=65 Lesions • In this within-person study (split-mouth design), at least one pair of lesions has been included per participant, with one lesion per pair being allocated to the treatment group (resin infiltration) and the other to the control group (mock treatment). Consequently, half of all study lesions belong to the treatment group and half to control group.
Lesion size Resin infiltration group · D1	12 Lesions n=65 Lesions • In this within-person study (split-mouth design), at least one pair of lesions has been included per participant, with one lesion per pair being allocated to the treatment group (resin infiltration) and the other to the control group (mock treatment). Consequently, half of all study lesions belong to the treatment group and half to control group.
Lesion size Resin infiltration group · D2	0 Lesions n=65 Lesions • In this within-person study (split-mouth design), at least one pair of lesions has been included per participant, with one lesion per pair being allocated to the treatment group (resin infiltration) and the other to the control group (mock treatment). Consequently, half of all study lesions belong to the treatment group and half to control group.
Lesion size Mock treatment group · E1	42 Lesions n=65 Lesions • In this within-person study (split-mouth design), at least one pair of lesions has been included per participant, with one lesion per pair being allocated to the treatment group (resin infiltration) and the other to the control group (mock treatment). Consequently, half of all study lesions belong to the treatment group and half to control group.
Lesion size Mock treatment group · E2	13 Lesions n=65 Lesions • In this within-person study (split-mouth design), at least one pair of lesions has been included per participant, with one lesion per pair being allocated to the treatment group (resin infiltration) and the other to the control group (mock treatment). Consequently, half of all study lesions belong to the treatment group and half to control group.
Lesion size Mock treatment group · D1	10 Lesions n=65 Lesions • In this within-person study (split-mouth design), at least one pair of lesions has been included per participant, with one lesion per pair being allocated to the treatment group (resin infiltration) and the other to the control group (mock treatment). Consequently, half of all study lesions belong to the treatment group and half to control group.
Lesion size Mock treatment group · D2	0 Lesions n=65 Lesions • In this within-person study (split-mouth design), at least one pair of lesions has been included per participant, with one lesion per pair being allocated to the treatment group (resin infiltration) and the other to the control group (mock treatment). Consequently, half of all study lesions belong to the treatment group and half to control group.

PRIMARY outcome

Timeframe: 3 years

Population: This study was terminated. The 3 year follow up was not reached for any enrolled participant at the time of termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months and 12 months

Population: The intended follow up time frame was 6, 12, 24 and 36 months. However, due to the termination of the study, only the 6 and 12 month follow ups were completed for the enrolled participants.

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). Reference: Anusavice K. Present and future approaches for the control of caries. J Dent Educ. 2005;69(5):538-854.

Outcome measures

Outcome measures
Measure	Resin Infiltration n=51 Lesions Resin infiltration of lesion according to manufacturers instruction in addition to preventive measures (standard-oral care hygiene treatment, diet counselling and fluoride regimen).	Mock Treatment n=51 Lesions Mock treatment of lesion in addition to preventive measures (standard-oral care hygiene treatment, diet counselling and fluoride regimen).
Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling) Progressed lesions at 6 month follow up	3 Lesions	6 Lesions
Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling) Progressed lesions at 12 month follow up	7 Lesions	9 Lesions

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Teeth included in the study were clincially assed for sensitivity to percussion, papillary bleeding, cold response.

Outcome measures

Outcome measures
Measure	Resin Infiltration n=51 Lesions Resin infiltration of lesion according to manufacturers instruction in addition to preventive measures (standard-oral care hygiene treatment, diet counselling and fluoride regimen).	Mock Treatment n=51 Lesions Mock treatment of lesion in addition to preventive measures (standard-oral care hygiene treatment, diet counselling and fluoride regimen).
Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response Sensitivity to percussion at 6 months	0 Lesions	0 Lesions
Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response Papillary bleeding at 6 months	19 Lesions	18 Lesions
Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response Papillary bleeding at 12 months	4 Lesions	4 Lesions
Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response Cold response at 6 months	1 Lesions	0 Lesions
Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response Cold response at 12 months	0 Lesions	1 Lesions
Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response Sensitivity to percussion at 12 months	0 Lesions	0 Lesions

Adverse Events

Resin Infiltration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mock Treatment

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