Remineralization Agents for the Treatment of White Spot Lesions

NCT04827966 | Terminated

• 1 other identifier: MOHWS
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

White Spot Lesion of Tooth

Keywords

fluoride; remineralization; esthetics; orthodontic brackets

Outcome Measures

Primary Outcomes (4)

• Enamel decalcification score recorded using Enamel decalcification index (EDI) by Banker and Richmond

  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

  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

  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

  The index is used to score the demineralisation of 4 tooth surfaces- mesial, distal, incisal and gingival.

  9 weeks following treatment

Secondary Outcomes (3)

• Number of patients with any adverse effects

  3 weeks

• Number of patients with any adverse effects

  6 weeks

• Number of patients with any adverse effects

  9 weeks

Study Arms (5)

Fluoride Varnish

ACTIVE COMPARATOR

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

Tooth Mousse

ACTIVE COMPARATOR

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

MI Paste

ACTIVE COMPARATOR

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)

Acidulated phosphate fluoride gel

ACTIVE COMPARATOR

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

Fluoride Mouthrinse

ACTIVE COMPARATOR

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

Interventions

Clinpro® 5% sodium fluoride plus tri calcium phosphate varnish OTHER

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

Tooth Mousse® - Casein phosphopeptide-Amorphous calcium phosphate (CPP - ACP)s OTHER

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.

Tooth Mousse

MI Paste® -Casein phosphopeptide-Amorphous calcium phosphate fluoride (CPP-ACPF) OTHER

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.

MI Paste

Zap® 1.23% APF gel - Acidulated phosphate fluoride OTHER

1.23% APF (Acidulated phosphate fluoride) gel is routinely used professional based fluoride for patients with high caries risk.

Acidulated phosphate fluoride gel

Listerine fluoride mouthrinse OTHER

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

Fluoride Mouthrinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ministry of Health, Bahrain: lead

Study Sites (1)

Halet bu maher health center

Al Muharraq, Bahrain

Location

Related Publications (8)

• Umeh OD, Utomi IL, Ndukwe AN, Izuka M. Demineralization preventive practices among Nigerian orthodontists-An evidence-based approach? Niger J Clin Pract. 2020 May;23(5):589-595. doi: 10.4103/njcp.njcp_315_19.

  PMID: 32367863 BACKGROUND

• Memarpour M, Shafiei F, Rafiee A, Soltani M, Dashti MH. Effect of hydroxyapatite nanoparticles on enamel remineralization and estimation of fissure sealant bond strength to remineralized tooth surfaces: an in vitro study. BMC Oral Health. 2019 May 28;19(1):92. doi: 10.1186/s12903-019-0785-6.

  PMID: 31138191 BACKGROUND

• Goswami M, Saha S, Chaitra TR. Latest developments in non-fluoridated remineralizing technologies. J Indian Soc Pedod Prev Dent. 2012 Jan-Mar;30(1):2-6. doi: 10.4103/0970-4388.95561.

  PMID: 22565510 RESULT

• Pradeep K, Kumar PR. Remineralizing agents in the non-invasive treatment of early carious lesions. Int J Dent Case Rep 2011; 1:73-84.

  RESULT

• Sonesson M, Bergstrand F, Gizani S, Twetman S. Management of post-orthodontic white spot lesions: an updated systematic review. Eur J Orthod. 2017 Apr 1;39(2):116-121. doi: 10.1093/ejo/cjw023.

  PMID: 27030284 RESULT

• Fernandez-Ferrer L, Vicente-Ruiz M, Garcia-Sanz V, Montiel-Company JM, Paredes-Gallardo V, Almerich-Silla JM, Bellot-Arcis C. Enamel remineralization therapies for treating postorthodontic white-spot lesions: A systematic review. J Am Dent Assoc. 2018 Sep;149(9):778-786.e2. doi: 10.1016/j.adaj.2018.05.010. Epub 2018 Jul 12.

  PMID: 30007454 RESULT

• Khoroushi M, Kachuie M. Prevention and Treatment of White Spot Lesions in Orthodontic Patients. Contemp Clin Dent. 2017 Jan-Mar;8(1):11-19. doi: 10.4103/ccd.ccd_216_17.

  PMID: 28566845 RESULT

• Cosma LL, Suhani RD, Mesaros A, Badea ME. Current treatment modalities of orthodontically induced white spot lesions and their outcome - a literature review. Med Pharm Rep. 2019 Jan;92(1):25-30. doi: 10.15386/cjmed-1090. Epub 2019 Jan 15.

  PMID: 30957083 RESULT

MeSH Terms

Interventions

Sodium Fluoride

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Prosthodontist and Dental Tutor

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 1, 2021
• Study Start: September 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)