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MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study (GC-WS)

Primary Purpose

Dental White Spots, Dental Caries

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste

1,100pm F-toothpaste and 0.5%NaF rinse

About this trial

This is an interventional prevention trial for Dental White Spots focused on measuring Prevention

Eligibility Criteria

11 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

age 11 or older,
good health,
either gender
present with at least two active white spot lesions on his/her anterior teeth at the start of the study
have a moderate or high caries risk according to CAMBRA (Caries Management By Risk Assessment) rules
require at least 12 additional months of full fixed appliance therapy from the time they are recruited for the study
able to cooperate for treatment in the dental chair and follow at-home instructions
have an understanding of the study
willing to comply with all study procedures and protocols
patient participant is able to provide written informed consent in English; if the participant is a minor, the parent/guardian is able to provide written informed consent in English and the patient participant is able to provide written assent in English
patient participant or if a minor, the parent/guardian, is willing to sign the "Authorization for Release of Personal Health Information and Use of Personally Unidentified Study Data for Research" form; data will only be used for research
verifiable records of bonding with Transbond Plus Self-Etching Primer (3M Unitek, Monrovia, CA) and Transbond Light Cure Adhesive or similar products
verifiable records that "ProSeal" has not been applied at any time during the orthodontic treatment

Exclusion Criteria:

untreated cavitated lesions
extensive composite fillings on buccal surfaces of front teeth/first bicuspids or more than one dental crown on front teeth/first bicuspids
has sealants or fluoride releasing cements on the buccal surface of the anterior teeth
in-office fluoride treatment in the last three months
history of using any products containing CCP-ACP (casein phosphopeptides and amorphous calcium phosphate; MI paste, chewing gums or candies, etc.), prescription Fluoride products, and Chlorhexidine use in the last three months
intrinsic or extremely heavy extrinsic staining
any signs of fluorosis in the dentition
any signs of morphologic/anatomical/developmental deviations in the teeth
previous history of in office bleaching treatment
subject not willing to stop the use of any other oral hygiene product than those prescribed/suggested
has underlying systemic disease which could alter enamel composition or formation
suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis)
use of medication causing dry mouth (extreme high caries risk)
subject is pregnant or lactating
milk protein allergy
any illness/condition that the investigator feels will affect the study outcome
will leave the area and will not be available for recall visits
subjects who are not willing to inform us about prospective visits of other dentist and will not allow us to discuss treatment with those dentist
subjects who are not willing to refrain from any additional professional tooth cleaning or any additional Fluoride application.

Sites / Locations

UCSF School of Dentistry - Dental Offices in Bay Area

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MI Paste & MI Varnish

Standard of Care

Arm Description

MI past will be applied by the patient every night; MI varnish will be applied every three months in the office

Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended

Outcomes

Primary Outcome Measures

Change in White Spot Lesions Count - Enamel Decalcification Index (EDI)

The area evaluation scheme of the Enamel Decalcification Index (EDI) divides the buccal surface of each tooth into 4 quadrants and then registers the possible existence of a white spot lesion (decalcification) in each of these 4 quadrants. For each quadrant the lesion can be scaled as: 0 = no decalcification, 1 = decalcification covering <50% of the area, 2 = decalcification covering > 50% of the area, 3 = decalcifications covering 100% of the area or severe decalcification with cavitation. Thus, for each tooth the value can range between 0 and 12. 16 teeth per subject were evaluated, for each subject the value of each tooth was added - thus the range per one subject can be between 0 and 192. A mean over all participants in one group was calculated. A higher score means a worse outcome.

Secondary Outcome Measures

Change in International Caries Detection and Assessment System (ICDAS II) to Score for Smooth Surfaces White Spot Lesions (WSL)

The International Caries Detection and Assessment System (ICDAS II) is a standardized method of caries lesion assessment.The score is based on apparent lesion severity, with scores from 0 to 6.The buccal surface of each tooth was divided into 4 quadrants, and for each quadrant a score was assigned with ICDAS scores: 0 = sound, 1 = first visual change in enamel, after air drying, 2 = distinct demineralization visual change in enamel, 3 = localized enamel breakdown due to caries with no visible dentin, 4 = surface with underlying dark shadow from dentin with or without enamel breakdown, 5 = distinct cavity with visible dentin, 6 = extensive cavity with visible dentin. The ICDAS scores were calculated as the sum of the highest ICDAS scores assigned to each examined tooth per subject. 16 teeth per subject were evaluated, thus, for each subject the value can range between 0 and 96. A mean over all participants in one group was calculated. A higher score means a worse outcome.

Full Information

NCT ID

NCT02424097

First Posted

April 15, 2015

Last Updated

April 8, 2020

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT02424097

Brief Title

MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study

Acronym

GC-WS

Official Title

MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this clinical study is to evaluate the efficacy of multiple applications of MI Varnish in combination with MI Paste Plus in caries protection and remineralization in comparison to the use of a control (Crest 1,100ppm Fluoride tooth paste, Fluoride rinse recommendation) in orthodontic patients in a randomized, single blind, prospective, controlled clinical trial over 12 months. The effect will be measured by white spot lesion regression and prevention as lesion count. Lesions will be scored using the Enamel Decalcification Index (EDI) area evaluation scheme (primary outcome), International Caries Detection and Assessment System (ICDAS), the caries lesion activity criteria (Nyvad criteria; Bente Nyvad, Scandinavian Researcher), and Quantitative Light Fluorescence (QLF, Inspektor Pro, Netherlands)/SOPROLIFE (SOPROLIFE fluorescence camera system, Acteon, France) evaluation in maxillary and mandibular anterior teeth with orthodontic brackets in treatment and control groups.

Detailed Description

The study is designed as randomized, single blind, prospective, clinical trial over 12 months. The subjects for this study will be recruited from the University of California at San Francisco UCSF, School of Dentistry, Orthodontic Clinic. Participants in the study will be patients, who are in orthodontic treatment or will start orthodontic treatment; subjects must have full fixed appliances, with brackets bonded to the buccal surfaces of the maxillary and mandibular incisors, canines and first bicuspids. Subjects will be of moderate or high caries risk according to Caries Risk Assessment and ATP (Adenosine triphosphate) bacteria testing. Subjects will present with at least two active white spot lesions on his/her anterior teeth at the start of the study. The age limitation is ≥ 11 years. The subjects will be randomly assigned to 1) Experimental group: MI Varnish and MI Paste Plus or 2) Control standard of care group: 1,100 ppm Fluoride tooth paste and recommendation to use OTC (Over-the-counter) Fluoride-rinse in the evening at home. The clinical study investigator will evaluate the labial/buccal surfaces of upper and lower anterior teeth (first bicuspid to first bicuspid) for white spot lesions (WSL) at baseline and at the end of 3, 6, and 12 months. Newly formed lesions and changes in existing white spot lesions will be documented (using Enamel Decalcification Index (EDI), ICDAS II, light digital photographs and blue fluorescence photography SOPROLIFE and QLF- Quantitative Light Fluorescence). All subjects will receive one professional tooth cleaning at baseline and at each other evaluation office visit to allow WSL evaluation (cleaning with ultrasonic device, and prophylaxis brush) and treatment application.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental White Spots, Dental Caries

Keywords

Prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MI Paste & MI Varnish

Arm Type

Experimental

Arm Description

MI past will be applied by the patient every night; MI varnish will be applied every three months in the office

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Description

Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended

Intervention Type

Drug

Intervention Name(s)

CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste

Intervention Description

MI Paste & MI Varnish- in-office: varnish application once every 3 months; at baseline, at the end of month 3, 6, and 9 (4 applications) - at-home: brushing with regular 1,100ppm F-toothpaste, 2x per day and MI Paste Plus, home application after brushing in the evening; 3-5 minutes with in-home application tray

Intervention Type

Drug

Intervention Name(s)

1,100pm F-toothpaste and 0.5%NaF rinse

Intervention Description

Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day)

Primary Outcome Measure Information:

Title

Change in White Spot Lesions Count - Enamel Decalcification Index (EDI)

Description

Time Frame

Baseline and 12-months

Secondary Outcome Measure Information:

Title

Change in International Caries Detection and Assessment System (ICDAS II) to Score for Smooth Surfaces White Spot Lesions (WSL)

Description

Time Frame

Baseline and 12-months

Other Pre-specified Outcome Measures:

Title

Change in Lesion Activity, Nyvad Criteria

Description

WS lesion activity will be determined using the Nyvad criteria;

Time Frame

Baseline and 12-months

Title

Change in SOPROLIFE

Description

fluorescence measurements using blue light fluorescence make WSLs visible for scoring;

Time Frame

Baseline and 12-months

Title

Change in Quantitative Light Fluorescence (QLF)

Description

Quantitative Light Fluorescence will be used to evaluate the WSL

Time Frame

Baseline and 12-months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 11 or older, good health, either gender present with at least two active white spot lesions on his/her anterior teeth at the start of the study have a moderate or high caries risk according to CAMBRA (Caries Management By Risk Assessment) rules require at least 12 additional months of full fixed appliance therapy from the time they are recruited for the study able to cooperate for treatment in the dental chair and follow at-home instructions have an understanding of the study willing to comply with all study procedures and protocols patient participant is able to provide written informed consent in English; if the participant is a minor, the parent/guardian is able to provide written informed consent in English and the patient participant is able to provide written assent in English patient participant or if a minor, the parent/guardian, is willing to sign the "Authorization for Release of Personal Health Information and Use of Personally Unidentified Study Data for Research" form; data will only be used for research verifiable records of bonding with Transbond Plus Self-Etching Primer (3M Unitek, Monrovia, CA) and Transbond Light Cure Adhesive or similar products verifiable records that "ProSeal" has not been applied at any time during the orthodontic treatment Exclusion Criteria: untreated cavitated lesions extensive composite fillings on buccal surfaces of front teeth/first bicuspids or more than one dental crown on front teeth/first bicuspids has sealants or fluoride releasing cements on the buccal surface of the anterior teeth in-office fluoride treatment in the last three months history of using any products containing CCP-ACP (casein phosphopeptides and amorphous calcium phosphate; MI paste, chewing gums or candies, etc.), prescription Fluoride products, and Chlorhexidine use in the last three months intrinsic or extremely heavy extrinsic staining any signs of fluorosis in the dentition any signs of morphologic/anatomical/developmental deviations in the teeth previous history of in office bleaching treatment subject not willing to stop the use of any other oral hygiene product than those prescribed/suggested has underlying systemic disease which could alter enamel composition or formation suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis) use of medication causing dry mouth (extreme high caries risk) subject is pregnant or lactating milk protein allergy any illness/condition that the investigator feels will affect the study outcome will leave the area and will not be available for recall visits subjects who are not willing to inform us about prospective visits of other dentist and will not allow us to discuss treatment with those dentist subjects who are not willing to refrain from any additional professional tooth cleaning or any additional Fluoride application.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Rechmann, DMD, PhD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSF School of Dentistry - Dental Offices in Bay Area

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

1390575

Citation

Mitchell L. Decalcification during orthodontic treatment with fixed appliances--an overview. Br J Orthod. 1992 Aug;19(3):199-205. doi: 10.1179/bjo.19.3.199. No abstract available.

Results Reference

result

PubMed Identifier

3276146

Citation

Geiger AM, Gorelick L, Gwinnett AJ, Griswold PG. The effect of a fluoride program on white spot formation during orthodontic treatment. Am J Orthod Dentofacial Orthop. 1988 Jan;93(1):29-37. doi: 10.1016/0889-5406(88)90190-4. No abstract available.

Results Reference

result

PubMed Identifier

21536209

Citation

Richter AE, Arruda AO, Peters MC, Sohn W. Incidence of caries lesions among patients treated with comprehensive orthodontics. Am J Orthod Dentofacial Orthop. 2011 May;139(5):657-64. doi: 10.1016/j.ajodo.2009.06.037.

Results Reference

result

PubMed Identifier

285114

Citation

Magness WS, Shannon IL, West DC. Office-applied fluoride treatments for orthodontic patients. J Dent Res. 1979 Apr;58(4):1427. doi: 10.1177/00220345790580042401. No abstract available.

Results Reference

result

PubMed Identifier

4528489

Citation

Stratemann MW, Shannon IL. Control of decalcification in orthodontic patients by daily self-administered application of a water-free 0.4 per cent stannous fluoride gel. Am J Orthod. 1974 Sep;66(3):273-9. doi: 10.1016/0002-9416(74)90291-7. No abstract available.

Results Reference

result

PubMed Identifier

6605091

Citation

Mizrahi E. Surface distribution of enamel opacities following orthodontic treatment. Am J Orthod. 1983 Oct;84(4):323-31. doi: 10.1016/s0002-9416(83)90348-2.

Results Reference

result

PubMed Identifier

6758594

Citation

Gorelick L, Geiger AM, Gwinnett AJ. Incidence of white spot formation after bonding and banding. Am J Orthod. 1982 Feb;81(2):93-8. doi: 10.1016/0002-9416(82)90032-x.

Results Reference

result

PubMed Identifier

5288673

Citation

Zachrisson BU, Zachrisson S. Caries incidence and oral hygiene during orthodontic treatment. Scand J Dent Res. 1971;79(6):394-401. doi: 10.1111/j.1600-0722.1971.tb02028.x. No abstract available.

Results Reference

result

PubMed Identifier

12532056

Citation

Gorton J, Featherstone JD. In vivo inhibition of demineralization around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2003 Jan;123(1):10-4. doi: 10.1067/mod.2003.47.

Results Reference

result

PubMed Identifier

1054935

Citation

Zachrisson BU. Fluoride application procedures in orthodontic practice, current concepts. Angle Orthod. 1975 Jan;45(1):72-81. doi: 10.1043/0003-3219(1975)0452.0.CO;2.

Results Reference

result

PubMed Identifier

1590288

Citation

Geiger AM, Gorelick L, Gwinnett AJ, Benson BJ. Reducing white spot lesions in orthodontic populations with fluoride rinsing. Am J Orthod Dentofacial Orthop. 1992 May;101(5):403-7. doi: 10.1016/0889-5406(92)70112-N.

Results Reference

result

PubMed Identifier

15266503

Citation

Benson PE, Parkin N, Millett DT, Dyer FE, Vine S, Shah A. Fluorides for the prevention of white spots on teeth during fixed brace treatment. Cochrane Database Syst Rev. 2004;(3):CD003809. doi: 10.1002/14651858.CD003809.pub2.

Results Reference

result

PubMed Identifier

16230329

Citation

Ogaard B, Alm AA, Larsson E, Adolfsson U. A prospective, randomized clinical study on the effects of an amine fluoride/stannous fluoride toothpaste/mouthrinse on plaque, gingivitis and initial caries lesion development in orthodontic patients. Eur J Orthod. 2006 Feb;28(1):8-12. doi: 10.1093/ejo/cji075. Epub 2005 Oct 17.

Results Reference

result

PubMed Identifier

17977295

Citation

Andersson A, Skold-Larsson K, Hallgren A, Petersson LG, Twetman S. Effect of a dental cream containing amorphous cream phosphate complexes on white spot lesion regression assessed by laser fluorescence. Oral Health Prev Dent. 2007;5(3):229-33.

Results Reference

result

PubMed Identifier

21083623

Citation

Beerens MW, van der Veen MH, van Beek H, ten Cate JM. Effects of casein phosphopeptide amorphous calcium fluoride phosphate paste on white spot lesions and dental plaque after orthodontic treatment: a 3-month follow-up. Eur J Oral Sci. 2010 Dec;118(6):610-7. doi: 10.1111/j.1600-0722.2010.00780.x.

Results Reference

result

PubMed Identifier

9294493

Citation

Reynolds EC. Remineralization of enamel subsurface lesions by casein phosphopeptide-stabilized calcium phosphate solutions. J Dent Res. 1997 Sep;76(9):1587-95. doi: 10.1177/00220345970760091101.

Results Reference

result

PubMed Identifier

17634723

Citation

Oshiro M, Yamaguchi K, Takamizawa T, Inage H, Watanabe T, Irokawa A, Ando S, Miyazaki M. Effect of CPP-ACP paste on tooth mineralization: an FE-SEM study. J Oral Sci. 2007 Jun;49(2):115-20. doi: 10.2334/josnusd.49.115.

Results Reference

result

PubMed Identifier

17561043

Citation

Sudjalim TR, Woods MG, Manton DJ, Reynolds EC. Prevention of demineralization around orthodontic brackets in vitro. Am J Orthod Dentofacial Orthop. 2007 Jun;131(6):705.e1-9. doi: 10.1016/j.ajodo.2006.09.043.

Results Reference

result

PubMed Identifier

14738126

Citation

Cai F, Shen P, Morgan MV, Reynolds EC. Remineralization of enamel subsurface lesions in situ by sugar-free lozenges containing casein phosphopeptide-amorphous calcium phosphate. Aust Dent J. 2003 Dec;48(4):240-3. doi: 10.1111/j.1834-7819.2003.tb00037.x.

Results Reference

result

PubMed Identifier

20887516

Citation

Uysal T, Amasyali M, Ozcan S, Koyuturk AE, Akyol M, Sagdic D. In vivo effects of amorphous calcium phosphate-containing orthodontic composite on enamel demineralization around orthodontic brackets. Aust Dent J. 2010 Sep;55(3):285-91. doi: 10.1111/j.1834-7819.2010.01236.x.

Results Reference

result

PubMed Identifier

23158136

Citation

Wang JX, Yan Y, Wang XJ. Clinical evaluation of remineralization potential of casein phosphopeptide amorphous calcium phosphate nanocomplexes for enamel decalcification in orthodontics. Chin Med J (Engl). 2012 Nov;125(22):4018-21.

Results Reference

result

PubMed Identifier

22051486

Citation

Robertson MA, Kau CH, English JD, Lee RP, Powers J, Nguyen JT. MI Paste Plus to prevent demineralization in orthodontic patients: a prospective randomized controlled trial. Am J Orthod Dentofacial Orthop. 2011 Nov;140(5):660-8. doi: 10.1016/j.ajodo.2010.10.025.

Results Reference

result

PubMed Identifier

23273358

Citation

Huang GJ, Roloff-Chiang B, Mills BE, Shalchi S, Spiekerman C, Korpak AM, Starrett JL, Greenlee GM, Drangsholt RJ, Matunas JC. Effectiveness of MI Paste Plus and PreviDent fluoride varnish for treatment of white spot lesions: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2013 Jan;143(1):31-41. doi: 10.1016/j.ajodo.2012.09.007.

Results Reference

result

PubMed Identifier

20348890

Citation

Bader JD. Casein phosphopeptide-amorphous calcium phosphate shows promise for preventing caries. Evid Based Dent. 2010;11(1):11-2. doi: 10.1038/sj.ebd.6400701.

Results Reference

result

PubMed Identifier

10343087

Citation

Nyvad B, Machiulskiene V, Baelum V. Reliability of a new caries diagnostic system differentiating between active and inactive caries lesions. Caries Res. 1999 Jul-Aug;33(4):252-60. doi: 10.1159/000016526.

Results Reference

result

PubMed Identifier

20020086

Citation

Terrer E, Koubi S, Dionne A, Weisrock G, Sarraquigne C, Mazuir A, Tassery H. A new concept in restorative dentistry: light-induced fluorescence evaluator for diagnosis and treatment. Part 1: Diagnosis and treatment of initial occlusal caries. J Contemp Dent Pract. 2009 Nov 1;10(6):E086-94.

Results Reference

result

PubMed Identifier

22502564

Citation

Rechmann P, Charland D, Rechmann BM, Featherstone JD. Performance of laser fluorescence devices and visual examination for the detection of occlusal caries in permanent molars. J Biomed Opt. 2012 Mar;17(3):036006. doi: 10.1117/1.JBO.17.3.036006.

Results Reference

result

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MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study

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