MI Varnish for the Prevention of White Spot Lesions

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT03446690
• Collaborator: (none)
• Enrollment: 62
• Arms: 2
• Actual Duration (Months): 12

Study Details

Study Description

Brief Summary

The current study aimed to determine if MI Varnish has an effect in preventing the formation of white spot lesions for patients undergoing orthodontic treatment. 33 subjects were prospectively recruited for the project as the MI Varnish group, with a control group of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes.Difference in prevention of white spot formation between the control and the study groups were evaluated through photographic records and clinical examination by using the Enamel Decalcification Index (EDI) scores.

Condition or Disease	Intervention/Treatment	Phase
White Spot Lesion; Orthodontic Treatment	Drug: MI Varnish; Other: Control group	Phase 4

Detailed Description

Orthodontists face two common iatrogenic treatment side effects, root resorption and enamel decalcification, with the latter occurring at a much higher frequency. While the processes that lead to enamel demineralization are understood, methods to diminish or perhaps eliminate degradation of enamel surfaces are being searched for. A new product, MI Varnish, is current available and has been shown in some initial case reports to be useful in reducing white spot lesions. It contains a special milk-derived protein RECALDENT TM (CPP-ACP) in which the casein phosphopeptides (CPP) bind to teeth, dentin, and oral mucosa while the amorphous calcium phosphate (ACP) releases calcium and phosphate. The current study aimed to determine if MI Varnish has an effect in preventing the formation of white spot lesions for patients undergoing orthodontic treatment. 33 subjects were prospectively recruited for the project as the MI Varnish group, with a control group of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. The study group received the MI Varnish on the day of bracket bonding. Subjects were recalled initially for 4 weeks (twice) and then at 3 monthly intervals. Difference in prevention of white spot formation between the control and the study groups were evaluated through photographic records and clinical examination by using the Enamel Decalcification Index (EDI) scores.

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 33 subjects were prospectively recruited for the project in the MI Varnish group. These subjects were studied against a control group of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, School of Dentistry, University of Alabama at Birmingham.33 subjects were prospectively recruited for the project in the MI Varnish group. These subjects were studied against a control group of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, School of Dentistry, University of Alabama at Birmingham.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Use of MI Varnish for the Prevention and Reduction of White Spot Lesions in Orthodontic Treatment
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MI Varnish Group 33 subjects were prospectively recruited for the project in the MI Varnish group. All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, UAB. MI Varnish were applied on their teeth initially for 4 weeks (twice) and then 3 monthly intervals.	Drug: MI Varnish; MI Varnish with RECALDENT™ (CPP-ACP) enhances enamel acid resistance and boosts salivary fluoride levels. This product remains on the teeth longer than other fluoride varnishes and contains high levels of fluoride and calcium released in the oral cavity. The difference is in the RECALDENT™ (CPP-ACP), which makes MI Varnish a natural and unique choice for your patients. Casein phosphopeptides (CPP) naturally occurs in milk casein; Amorphous Calcium Phosphate (ACP), which is found in the RECALDENT™, is also the source of calcium and phosphate. In the oral cavity, CPP binds to oral surfaces such as teeth, dentin, oral mucosa and biofilm. Calcium and phosphate ions are the building blocks for healthy teeth and MI Varnish delivers bioavailable calcium and phosphate ions into the saliva.
Other: Control group A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, School of Dentistry, University of Alabama at Birmingham. No intervention for this group.	Other: Control group; Participants received routine treatment and oral hygiene regimes. No intervention for this group.

Outcome Measures

Primary Outcome Measures

1. Enamel Decalcification Index (EDI) Scores [Photographs were taken for 4 times at monthly intervals. EDI scores were measured and assessed at 1, 2, 3 and 4 months, Month 4 reported. The duration of the observation is an average of 4 months.]

   Photographic records will be used to determine the improvements in the white spot lesions. A standard intra-oral photographic camera will be utilized and the photographs will be taken in a light controlled environment and photographs will be captured in a pre-set photographic protocol. The Enamel decalcification index (EDI) will be used to determine the number of white spot lesions present at each time frame.Enamel decalcification index calculation: The facial surface of each tooth was divided into 4 areas (m, Mesial; g, gingival; d, distal; o, occlusal). A score was allocated for each area of each tooth: 0, no decalcification, to 3, decalcifications covering 100% of the area at each time period. Analysis was done at the tooth level, aggregating the enamel decalcification scores from all four areas, creating an EDI for each tooth ranging potentially from 0 to 12. Higher EDI scores indicate more decalcification of teeth and represent a worse outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients seeking orthodontic treatment and receiving routine treatment and oral hygiene regimes.

Exclusion Criteria:

• Any medical or dental condition that in the opinion of the investigator could impact study results during the expected length of the study;

• Patient is currently using any investigational drug or any other investigational device;

• Patient plans to relocate or move within six months of enrollment.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Chung H Kau, BDS, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol - Jan 1, 2018
• Statistical Analysis Plan - Jan 1, 2018

More Information

Publications

None provided.

• Responsible Party: Chung How Kau, Professor and Chairman, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03446690
• Other Study ID Numbers: 1135815
• First Posted: Feb 27, 2018
• Last Update Posted: Jun 12, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Chung How Kau, Professor and Chairman, University of Alabama at Birmingham: Enamel decalcification

Study Results

Participant Flow

Arm/Group Title	MI Varnish Group	Control Group
Arm/Group Description	33 subjects were initially recruited in the study for MI Varnish. 7 subjects failed to return or did not meet the study protocol. 29 subjects were recruited retrospectively from a previous study and the results compared. MI Varnish were applied on their teeth initially for 4 weeks (twice) and then 3 monthly intervals.	A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. No intervention for this group. Control group: Participants received routine treatment and oral hygiene regimes. No intervention for this group.
Period Title: Overall Study
STARTED	33	29
COMPLETED	26	29
NOT COMPLETED	7	0

Baseline Characteristics

Arm/Group Title	MI Varnish Group	Control Group	Total
Arm/Group Description	33 subjects were prospectively recruited for the project in the MI Varnish group. All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, UAB.	A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. All subjects were patients seeking orthodontic treatment at the Department of Orthodontics, School of Dentistry, University of Alabama at Birmingham.	Total of all reporting groups
Overall Participants	26	29	55
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.5 (6.7)	28.5 (5.2)	29 (5.94)
Sex: Female, Male (Count of Participants)
Female	16 61.5%	16 55.2%	32 58.2%
Male	10 38.5%	13 44.8%	23 41.8%
Region of Enrollment (Count of Participants)
Central America	18 69.2%	20 69%	38 69.1%
Africa	6 23.1%	9 31%	15 27.3%
China	2 7.7%	0 0%	2 3.6%

Outcome Measures

1. Primary Outcome

Title	Enamel Decalcification Index (EDI) Scores
Description	Photographic records will be used to determine the improvements in the white spot lesions. A standard intra-oral photographic camera will be utilized and the photographs will be taken in a light controlled environment and photographs will be captured in a pre-set photographic protocol. The Enamel decalcification index (EDI) will be used to determine the number of white spot lesions present at each time frame.Enamel decalcification index calculation: The facial surface of each tooth was divided into 4 areas (m, Mesial; g, gingival; d, distal; o, occlusal). A score was allocated for each area of each tooth: 0, no decalcification, to 3, decalcifications covering 100% of the area at each time period. Analysis was done at the tooth level, aggregating the enamel decalcification scores from all four areas, creating an EDI for each tooth ranging potentially from 0 to 12. Higher EDI scores indicate more decalcification of teeth and represent a worse outcome.
Time Frame	Photographs were taken for 4 times at monthly intervals. EDI scores were measured and assessed at 1, 2, 3 and 4 months, Month 4 reported. The duration of the observation is an average of 4 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MI Varnish Group	Control Group
Arm/Group Description	33 subjects were initially recruited in the study for MI Varnish. 7 subjects failed to return or did not meet the study protocol. MI Varnish were applied on their teeth initially for 4 weeks (twice) and then 3 monthly intervals.	A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. No intervention for this group. Control group: Participants received routine treatment and oral hygiene regimes. No intervention for this group.
Measure Participants	26	29
Total EDI score of 1-month visit	1.038	1
Total EDI score of 2-month visit	1.308	2.724
Total EDI score of 3-month visit	1.923	3.966
Total EDI score of 4-month visit	2.692	5.897

Adverse Events

Time Frame	During and within 6 months from the end of the treatment.
Arm/Group Title	MI Varnish Group		Control Group
Arm/Group Description	33 subjects were initially recruited in the study for MI Varnish. 7 subjects failed to return or did not meet the study protocol. MI Varnish were applied on their teeth initially for 4 weeks (twice) and then 3 monthly intervals.		A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. No intervention for this group. Control group: Participants received routine treatment and oral hygiene regimes. No intervention for this group.
All Cause Mortality
	MI Varnish Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/29 (0%)
Serious Adverse Events
	MI Varnish Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	MI Varnish Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/29 (0%)

Limitations/Caveats

We attempt to overcome the compliance barrier giving the patients brushing technique instructions as a control of their actual compliance with the protocol. However it was observed plaque accumulation and gingival inflammation on some patients.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.