White Spot Lesion of ToothNCT04827966
Remineralization Agents for the Treatment of White Spot Lesions
A study testing Clinpro® 5% sodium fluoride plus tri calcium phosphate varnish, Tooth Mousse® - Casein phosphopeptide-Amorphous calcium phosphate (CPP - ACP)s and MI Paste® -Casein phosphopeptide-Amorphous calcium phosphate fluoride (CPP-ACPF) in people with White Spot Lesion of Tooth, run by Ministry of Health, Bahrain at 1 site in Bahrain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- Clinpro® 5% sodium fluoride plus tri calcium phosphate varnish, Tooth Mousse® - Casein phosphopeptide-Amorphous calcium phosphate (CPP - ACP)s and MI Paste® -Casein phosphopeptide-Amorphous calcium phosphate fluoride (CPP-ACPF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBahrain
- Study dates
- 1 Sep 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- White Spot Lesion of Tooth
- Being tested
- Clinpro® 5% sodium fluoride plus tri calcium phosphate varnish, Tooth Mousse® - Casein phosphopeptide-Amorphous calcium phosphate (CPP - ACP)s, MI Paste® -Casein phosphopeptide-Amorphous calcium phosphate fluoride (CPP-ACPF), Zap® 1.23% APF gel - Acidulated phosphate fluoride, Listerine fluoride mouthrinse
- Keywords
- fluoride, remineralization, esthetics, orthodontic brackets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinpro® 5% sodium fluoride plus tri calcium phosphate varnishOther
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)sOther
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)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.
Zap® 1.23% APF gel - Acidulated phosphate fluorideOther
1.23% APF (Acidulated phosphate fluoride) gel is routinely used professional based fluoride for patients with high caries risk.
Listerine fluoride mouthrinseOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Listerine fluoride mouthrinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 weeks following treatment
Secondary outcomes (3)
Number of patients with any adverse effects
Any adverse effects reported in the form of allergy , hypersensitivity, discoloration.
Measured: 3 weeks
Number of patients with any adverse effects
Any adverse effects reported in the form of allergy , hypersensitivity, discoloration.
Measured: 6 weeks
Number of patients with any adverse effects
Any adverse effects reported in the form of allergy , hypersensitivity, discoloration.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Sep 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Why it stopped: Funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for White Spot Lesion of ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Bahrain
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gowri Sivaramakrishnan, Ministry of Health, Bahrain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827966
- Sponsor's protocol ID
- MOHWS
- Status last verified
- Nov 2023
- First submitted
- 28 Mar 2021
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32367863Memarpour 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.
PubMed 31138191Goswami 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.
PubMed 22565510Pradeep 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.
PubMed 27030284Fernandez-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.
PubMed 30007454Khoroushi 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.
PubMed 28566845Cosma 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.
PubMed 30957083
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Remineralization Agents Used for the Treatment of White Spot Lesions
- ClinicalTrials.gov ID
- NCT04827966
- Acronym / sponsor ID
- MOHWS
- Conditions
- White Spot Lesion of Tooth
- Keywords
- fluoride, remineralization, esthetics, orthodontic brackets
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding issues
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ministry of Health, BahrainOther government
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Fluoride Varnish | Active comparator | Other: Clinpro® 5% sodium fluoride plus tri calcium phosphate varnishClinpro® 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. |
| Tooth Mousse | Active comparator | Other: Tooth Mousse® - Casein phosphopeptide-Amorphous calcium phosphate (CPP - ACP)sTooth 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. |
| MI Paste | Active comparator | 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. 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. |
| Acidulated phosphate fluoride gel | Active comparator | Other: Zap® 1.23% APF gel - Acidulated phosphate fluorideA 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. |
| Fluoride Mouthrinse | Active comparator | Other: Listerine fluoride mouthrinseListerine® 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinpro® 5% sodium fluoride plus tri calcium phosphate varnishClinpro® 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 | Other | Fluoride Varnish |
| Tooth Mousse® - Casein phosphopeptide-Amorphous calcium phosphate (CPP - ACP)sTooth 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. | Other | Tooth Mousse |
| 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. | Other | MI Paste |
| Zap® 1.23% APF gel - Acidulated phosphate fluoride1.23% APF (Acidulated phosphate fluoride) gel is routinely used professional based fluoride for patients with high caries risk. | Other | Acidulated phosphate fluoride gel |
| Listerine fluoride mouthrinseListerine® 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 | Fluoride Mouthrinse |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Number of patients with any adverse effects
Time frame: 3 weeks
Number of patients with any adverse effects
Time frame: 6 weeks
Number of patients with any adverse effects
Time frame: 9 weeks
Results and safety
The study was stopped early (reason given: Funding issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Background: PubMed 32367863Umeh 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.
- Background: PubMed 31138191Memarpour 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.
- Results publication: PubMed 22565510Goswami 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.
- Results publicationPradeep K, Kumar PR. Remineralizing agents in the non-invasive treatment of early carious lesions. Int J Dent Case Rep 2011; 1:73-84.
- Results publication: PubMed 27030284Sonesson 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.
- Results publication: PubMed 30007454Fernandez-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.
- Results publication: PubMed 28566845Khoroushi 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.
- Results publication: PubMed 30957083Cosma 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinpro® 5% sodium fluoride plus tri calcium phosphate varnish, Tooth Mousse® - Casein phosphopeptide-Amorphous calcium phosphate (CPP - ACP)s and MI Paste® -Casein phosphopeptide-Amorphous calcium phosphate fluoride (CPP-ACPF) in people with White Spot Lesion of Tooth, run by Ministry of Health, Bahrain at 1 site in Bahrain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bahrain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enamel decalcification score recorded using Enamel decalcification index (EDI) by Banker and Richmond (time frame: Baseline (before treatment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04827966, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.