Remineralization Agents for the Treatment of White Spot Lesions
NCT ID: NCT04827966
Last Updated: 2023-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
12 participants
INTERVENTIONAL
2022-09-01
2022-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Trial of Tooth Mousse to Remineralise Post-orthodontic Treatment White Spot Lesions
NCT01344473
The Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention
NCT04788550
A Prospective, Randomized, Clinical Study on the Effects of CPP-ACP-paste, Fluoride and a Combination on the Evolution of White Spot Lesions in Orthodontic Patients After Debonding.
NCT05710874
White Spot Lesions Treatment in Orthodontic
NCT06051981
Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Treatment
NCT05733676
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
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.
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.
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.
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.
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.
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.
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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.
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.
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.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ministry of Health, Bahrain
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gowri Sivaramakrishnan
Specialist Prosthodontist and Dental Tutor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Halet bu maher health center
Al Muharraq, , Bahrain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Pradeep K, Kumar PR. Remineralizing agents in the non-invasive treatment of early carious lesions. Int J Dent Case Rep 2011; 1:73-84.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MOHWS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.