Remineralization Agents for the Treatment of White Spot Lesions

November 6, 2023 updated by: Gowri Sivaramakrishnan, Ministry of Health, Bahrain

A Randomized Controlled Trial on the Remineralization Agents Used for the Treatment of White Spot Lesions

Clinically, formation of white spots can occur as early as 4 weeks into orthodontic treatment and very common in high caries risk individuals. When left untreated, the calcium loss continues, the enamel breaks down entirely, and a cavity appears. These can cause caries thereby leading to poor esthetics and patient dissatisfaction. The labio-gingival area of the lateral incisors is the most common site for WSL and the maxillary posterior segments are the least common site, with males affected more in comparison with females.Hence inducing remineralization of existing lesions is the key treatment to prevent cavitation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

White spot lesion (WSL) is the earliest sign of demineralization of the enamel and a common problem caused because of plaque accumulation and poor oral hygiene. These WSLs are of great concern in young patients, considering that esthetics is the prime reason for young patients to seek dental treatment. The appearance of these areas of demineralization should be prevented and appropriate strategies must be undertaken in remineralizing these lesions. A recent meta-analysis on the incidence and prevalence of these lesions in orthodontic patients included 14 studies indicated that the incidence of new carious lesions formed during orthodontic treatment in patients was 45.8% and the prevalence of lesions in patients undergoing orthodontic treatment was 68.4%. This is considerably high and needs urgent attention.

Enamel decalcification can occur as a result of orthodontic bracket or any other foreign body attached onto the tooth surface, and provoked by poor oral hygiene. It is an incipient caries in the subsurface beneath an intact enamel outer surface. It is characterized by chalky white appearance (WSLs) mostly around the brackets, and have different refractive index than intact enamel surface.If the WSL's are left untreated it can progress to break down the enamel surface and develop into advance stages of carious lesion that indicate esthetic restorations or in more advance cases a prosthodontic intervention.

Research has shown good evidence on non-invasive treatment of WSLs such as establishing good oral hygiene and the use of fluoride and non-fluoride remineralizing agents. Fluoride containing agents are available as high-fluoride toothpaste, fluoride mouthwash, gels and varnish. Recently, other non-fluoride materials and techniques such as casein phosphopeptide -amorphous calcium phosphate (CPP-ACP) has shown promising results.

Clinpro® is 5% sodium fluoride varnish and is indicated to be used for hypersensitive as well as for demineralized teeth. It flows smoothly on moist teeth and binds firmly to their surfaces. 1ml of Clinpro® contain 50 mg of sodium fluoride. Fluoride varnish placed around orthodontic brackets during treatment has been shown to reduce the incidence and prevalence of WSL. Tooth Mousse® contains Casein phosphopeptide-Amorphous calcium phosphate (CPP - ACP) is product from the milk casein. This delivers the necessary Calcium and Phosphate ions to the tooth, which will reduce the risk of caries and white spot by enhancing tooth remineralization. MI Paste® which is Casein phosphopeptide-Amorphous calcium phosphate fluoride (CPP-ACPF) additional contains fluoride in addition to CPP-ACP. The level of fluoride is 900ppm which approximates that in adult strength toothpastes. When CPP-ACPF is applied in the oral environment, it will bind to biofilms, plaque, bacteria, hydroxyapatite and soft tissue localizing bio-available calcium, phosphate and fluoride. Recent studies have investigated the remineralization potential of CPP-ACP combined with fluoride and have found a synergistic effect when these are administered together, which is the composition in MI paste. Patients who have previous history of milk protein allergy or lactose intolerance are not suitable to use MI paste or tooth mousse. This is based on the manufacturer's instructions. However, there is no published data on these allergic reactions to CPP-ACP products so far. 1.23% APF (Acidulated phosphate fluoride) gel is routinely used professional based fluoride for patients with high caries risk. Listerine® Sodium fluoride (0.2%) mouth rinses are effective in reducing caries and inhibit carbohydrate utilization of oral microorganisms by blocking enzymes involved in the bacterial glycolytic pathway studies have shown sodium fluoride mouth rinse to be effective in reducing S. mutans counts.

Considering the variety of agents that are available the aim of this clinical study is to compare Clinpro® 5% sodium fluoride plus tri calcium phosphate varnish, Tooth mousse® CPP-ACP without fluoride, MI Paste® CPP-ACP with fluoride and 0.2% sodium fluoride mouthwash in remineralization of white spot lesions.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bahrain
      • Muharraq, Bahrain
        • Halet bu maher health center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult patients attending the dental clinic for treatment of white spot lesions on their teeth
  • using fluoride toothpaste once or twice daily for brushing
  • does not use any other form of fluoride
  • history of recent fixed orthodontic treatment
  • presenting with white spot lesions on minimum of three anterior or posterior teeth on the labial surfaces
  • provide written informed consent

Exclusion Criteria:

  • Patients who do not fit into the above mentioned inclusion criteria.
  • Patients who are allergic to milk or any other milk products will be excluded from the study. Milk protein allergy and lactose intolerance tests will be performed on participants belonging to active comparators Tooth Mousse and MI paste which contain casein phosphoprotein before enrolling them in the trial.
  • Patients who are vegan and do not use or consume any animal products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fluoride Varnish
Clinpro® is 5% sodium fluoride varnish and is indicated to be used for hypersensitive as well as for demineralized teeth. It flows smoothly on moist teeth and binds firmly to their surfaces. 1ml of Clinpro® contain 50 mg of sodium fluoride. 0.2-0.5ml of the varnish is applied onto the tooth surface after through cleaning. One coats of the varnish will be applied and patient will be instructed not to rinse with water or eat for 30 minutes. This is based on the manufacturer's instructions.
Other: Clinpro® 5% sodium fluoride plus tri calcium phosphate varnish
Clinpro® is 5% sodium fluoride varnish and is indicated to be used for hypersensitive as well as for demineralized teeth. It flows smoothly on moist teeth and binds firmly to their surfaces. 1ml of Clinpro® contain 50 mg of sodium fluoride
Active Comparator: Tooth Mousse
Tooth Mousse® contains Casein phosphopeptide-Amorphous calcium phosphate (CPP - ACP) is product from the milk casein. This delivers the necessary Calcium and Phosphate ions to the tooth, which will reduce the risk of caries and white spot by enhancing tooth remineralization. One tube of the Tooth Mousse will be prescribed to the patient. Patient will be instructed to apply the product using finger every night after brushing and flossing. This is continued till the prescribed product is finished. This is approximately calculated to be about 8 to 12 weeks.Patient is instructed to leave the paste for about 3 minutes and then rinse. This is based on the manufacturer's instructions.
Other: Tooth Mousse® - Casein phosphopeptide-Amorphous calcium phosphate (CPP - ACP)s
Tooth Mousse® contains Casein phosphopeptide-Amorphous calcium phosphate (CPP - ACP) is product from the milk casein. This delivers the necessary Calcium and Phosphate ions to the tooth, which will reduce the risk of caries and white spot by enhancing tooth remineralization.
Active Comparator: MI Paste
MI Paste® which is Casein phosphopeptide-Amorphous calcium phosphate fluoride (CPP-ACPF) additional contains fluoride in addition to CPP-ACP. The level of fluoride is 900ppm which approximates that in adult strength toothpastes. Recent studies have investigated the remineralization potential of CPP-ACP combined with fluoride and have found a synergistic effect when these are administered together, which is the composition in MI paste. One tube of the MI Paste will be prescribed to the patient. Patient will be instructed to apply the product using finger every night after brushing and flossing. This is continued till the prescribed product is finished. This is approximately calculated to be about 8 to 12 weeks.Patient is instructed to leave the paste for about 3 minutes and then rinse. This is based on the manufacturer's instructions.
Other: MI Paste® -Casein phosphopeptide-Amorphous calcium phosphate fluoride (CPP-ACPF)
MI Paste® which is Casein phosphopeptide-Amorphous calcium phosphate fluoride (CPP-ACPF) additional contains fluoride in addition to CPP-ACP. The level of fluoride is 900ppm which approximates that in adult strength toothpastes.
Active Comparator: Acidulated phosphate fluoride gel
A stable thixotropic gel providing 1.23% fluoride ion. This is only for professional use and applied by the dentist. The teeth is cleaned and polished and the gel is applied onto a tray. It is filled upto one third of the tray according to manufacturer's instructions. The tray is then inserted into the mouth and the patient is asked to gently bite down lightly for 1 to 4 minutes.The tray is then removed and patient is asked to expectorate any material in the mouth. The patient is instructed not to eat, rinse or drink for 30 minutes.
Other: Zap® 1.23% APF gel - Acidulated phosphate fluoride
1.23% APF (Acidulated phosphate fluoride) gel is routinely used professional based fluoride for patients with high caries risk.
Active Comparator: Fluoride Mouthrinse
Listerine® Sodium fluoride (0.2%) mouth rinses are effective in reducing caries and inhibit carbohydrate utilization of oral microorganisms by blocking enzymes involved in the bacterial glycolytic pathway studies have shown sodium fluoride mouth rinse to be effective in reducing S. mutans counts.
Other: Listerine fluoride mouthrinse
Listerine® Sodium fluoride (0.2%) mouth rinses are effective in reducing caries and inhibit carbohydrate utilization of oral microorganisms by blocking enzymes involved in the bacterial glycolytic pathway studies have shown sodium fluoride mouth rinse to be effective in reducing S. mutans counts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enamel decalcification score recorded using Enamel decalcification index (EDI) by Banker and Richmond
Time Frame: Baseline (before treatment)
The index is used to score the demineralisation of 4 tooth surfaces- mesial, distal, incisal and gingival.
Baseline (before treatment)
Enamel decalcification score recorded using Enamel decalcification index (EDI) by Banker and Richmond
Time Frame: 3 weeks following treatment
The index is used to score the demineralisation of 4 tooth surfaces- mesial, distal, incisal and gingival.
3 weeks following treatment
Enamel decalcification score recorded using Enamel decalcification index (EDI) by Banker and Richmond
Time Frame: 6 weeks following treatment
The index is used to score the demineralisation of 4 tooth surfaces- mesial, distal, incisal and gingival.
6 weeks following treatment
Enamel decalcification score recorded using Enamel decalcification index (EDI) by Banker and Richmond
Time Frame: 9 weeks following treatment
The index is used to score the demineralisation of 4 tooth surfaces- mesial, distal, incisal and gingival.
9 weeks following treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with any adverse effects
Time Frame: 3 weeks
Any adverse effects reported in the form of allergy , hypersensitivity, discoloration.
3 weeks
Number of patients with any adverse effects
Time Frame: 6 weeks
Any adverse effects reported in the form of allergy , hypersensitivity, discoloration.
6 weeks
Number of patients with any adverse effects
Time Frame: 9 weeks
Any adverse effects reported in the form of allergy , hypersensitivity, discoloration.
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Bahrain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

March 28, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOHWS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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