Enamel Hypomineralization, DentalNCT05940701
The Effectiveness of Biomimetic Materials in Preventing Enamel Demineralization During Fixed Orthodontic Treatment
A study testing Curasept Biosmalto Mousse and toothpaste and Colgate toothpaste in people with Enamel Hypomineralization, Dental, run by University of Baghdad at 1 site in Iraq.
Trial summary
This study will be done to evaluate the impact of Biosmalto Impact Action Mousse™ on the development and healing of WSLs in individuals receiving orthodontic treatment. The control group received a fluoridated toothpaste (Colgate toothpaste). Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Enamel Hypomineralization, Dental
- What is being tested?
- Curasept Biosmalto Mousse and toothpaste and Colgate toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteIraq
- Study dates
- 15 Jan 2023to 1 Jan 2024
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Willingness to participate.
- No underlying medical conditions requiring medications that may cause dryness of the mouth.
- Fully erupted permanent maxillary and mandibular canines and incisors that have not been restored.
Who cannot join
- Receiving professional fluoridation within the last three months.
- Untreated cavitated lesions or significant restorations on the facial surfaces of study teeth.
- Labial restoration of any of the study teeth.
- Missing any of the study teeth.
- Severely rotated any of the study teeth (limiting the appearance of buccal surfaces).
- Patients with enamel hypoplasia, dental fluorosis or tetracycline pigmentation.
Show all 10Show fewer
- Dental anomalies related to morphology, anatomy, or development.
- Pregnancy and xerostomia.
- Heavy smokers.
- Craniofacial syndromes such as clefts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Biomimetic Materials in Preventing Enamel Demineralization During Fixed Appliance Orthodontic Treatment: a Randomized Clinical Trial
This study will be done to evaluate the impact of Biosmalto Impact Action Mousse™ on the development and healing of WSLs in individuals receiving orthodontic treatment.
The control group received a fluoridated toothpaste (Colgate toothpaste). The intervention group received Curasept toothpaste and additionally at each visit a Curasept Biosmalto Mousse was applied on the facial surface of the maxillary and mandibular anterior teeth using a tray.
For each patient recruited, identical toothbrushes and oral care instructions were given. The patients received instructions to brush their teeth for at least two minutes using an up-down motion on their anterior teeth and a circular motion on their posterior teeth at least three times/day.
Read the detailed description
This study is a multicenter randomized clinical trial with blinded parallel groups, simple randomization, an equal allocation ratio (1:1), and no stratification.The patients will be initially assessed for eligibility to be included in the study by the investigator.The study was verbally explained to those who fulfilled the inclusion criteria in order to get their first consent for participation. After that, they received the patient information sheet (Appendix), which explained the purpose of the research. The patients were instructed to thoroughly read the informational material at home and tell the researcher of their intention to participate at the next visit. Participants had to either sign the consent form (which was attached to the patient information sheet) or get their parents' permission (if the participant was under the age of 18 years). The investigator provided the patients with further information or reassurance about the trial if needed.
All the participants received a standardized treatment protocol. The patients were treated with straight wire appliance using metal brackets (3BOrtho, China). Initially, teeth polishing was performed with pumice and rubber cup for 10 seconds using a low-speed handpiece, followed by water rinsing and air drying (oil-free air spray for 30 seconds). Bonding technique was performed using 37% phosphoric acid for 30 seconds (Heinig and Hartmann, 2008b), then washed with water for 15-20 seconds, and dried for 10 seconds. A thin coat of primer was applied to the etched surfaces by an applicator and cured for 15 seconds by the LED light-curing unit. The brackets were bonded using similar adhesive (3B Ortho, white glue, China) and checked so that no obvious extra adhesive is remained on the tooth surface around the brackets. The control group received a fluoridated toothpaste (Colgate toothpaste). The intervention group received Curasept toothpaste and additionally at each visit a Curasept Biosmalto Mousse was applied on the facial surface of the maxillary and mandibular anterior teeth using a tray.
For each patient recruited, identical toothbrushes and oral care instructions were given. The patients received instructions to brush their teeth for at least two minutes using an up-down motion on their anterior teeth and a circular motion on their posterior teeth at least three times/day. Additionally, the patients were instructed not to use any additional antimicrobial-containing products (mouthwash, toothpaste, gel).
- Conditions
- Enamel Hypomineralization, Dental
- Being tested
- Curasept Biosmalto Mousse and toothpaste, Colgate toothpaste
- Medical subject headings
- Dental Enamel Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curasept Biosmalto Mousse and toothpasteCombination product
at each visit a Curasept Biosmalto Mousse will be applied on the facial surface of the maxillary and mandibular anterior teeth using a tray.
Colgate toothpasteOther
The control group will receive a fluoridated toothpaste (Colgate toothpaste)
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The intervention group will receive Curasept toothpaste with instructions and additionally at each visit a Curasept Biosmalto Mousse will be applied on the facial surface of the maxillary and mandibular anterior teeth using a tray. Receives: Combination Product: Curasept Biosmalto Mousse and toothpaste |
| control group | Placebo comparator | The control group will receive a fluoridated toothpaste (Colgate toothpaste) and instructed to brush at least three times/day. Receives: Other: Colgate toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
WSLs evaluation
To evaluate the number of WSLs on the labial surfaces of maxillary and mandibular anterior teeth using enamel white spot lesion index (WSLI), ICDAS (International caries detection and assessment system) and DIAGNOdent pen scores at each visit and after six months during orthodontic treatment.
Gorelick Index :
0: no WSLs
- Slight WSLs
- extended or excessive WSLs
- WSLs with cavitation
DIAGNOdent pen reading:
0 - 10 Healthy Tooth Structure 11-20 Outer Half Enamel Caries 21-30 Inner Half Enamel Caries 30+ Dentin Caries
Measured: 6 month
Secondary outcomes (1)
amount of plaque and gingival bleeding
To evaluate the amount of plaque and gingival bleeding by using visible plaque index (VPI) gingival bleeding index (GBI) at each visit (4-6 weeks) Visible plaque index (VPI) 0: non-visible plaque 1: visible plaque Gingival bleeding index (GBI) 0: no gingival bleeding
1: gingival bleeding
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start15 Jan 2023
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Enamel Hypomineralization, DentalStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Husam Assim, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940701
- Sponsor's protocol ID
- 763423
- Status last verified
- Jun 2023
- First submitted
- 25 Jun 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17977295Ardu S, Castioni NV, Benbachir N, Krejci I. Minimally invasive treatment of white spot enamel lesions. Quintessence Int. 2007 Sep;38(8):633-6.
PubMed 17823680Boersma JG, van der Veen MH, Lagerweij MD, Bokhout B, Prahl-Andersen B. Caries prevalence measured with QLF after treatment with fixed orthodontic appliances: influencing factors. Caries Res. 2005 Jan-Feb;39(1):41-7. doi: 10.1159/000081655.
PubMed 15591733Cosma 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 30957083Du J, Yuan Y, Si T, Lian J, Zhao H. Customized optimization of metabolic pathways by combinatorial transcriptional engineering. Nucleic Acids Res. 2012 Oct;40(18):e142. doi: 10.1093/nar/gks549. Epub 2012 Jun 19.
PubMed 22718979Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.
PubMed 19897823Gizani S, Kloukos D, Papadimitriou A, Roumani T, Twetman S. Is Bleaching Effective in Managing Post-orthodontic White-spot Lesions? A Systematic Review. Oral Health Prev Dent. 2020 Feb 14;18(1):2-10. doi: 10.3290/j.ohpd.a44113.
PubMed 32051965Gorelick 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.
PubMed 6758594Iafisco M, Degli Esposti L, Ramirez-Rodriguez GB, Carella F, Gomez-Morales J, Ionescu AC, Brambilla E, Tampieri A, Delgado-Lopez JM. Fluoride-doped amorphous calcium phosphate nanoparticles as a promising biomimetic material for dental remineralization. Sci Rep. 2018 Nov 19;8(1):17016. doi: 10.1038/s41598-018-35258-x.
PubMed 30451901Sonesson 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 27030284Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1.
PubMed 21208070Assim SH, Yassir YA. Effect of biomimetic tooth mousse and toothpaste on the incidence of white spot lesions during fixed appliance orthodontic treatment: A randomized clinical trial. J Taibah Univ Med Sci. 2025 Jun 25;20(3):405-416. doi: 10.1016/j.jtumed.2025.06.004. eCollection 2025 Jun.
PubMed 40657473
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Biomimetic Materials in Preventing Enamel Demineralization During Fixed Appliance Orthodontic Treatment: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05940701
- Acronym / sponsor ID
- 763423
- Conditions
- Enamel Hypomineralization, Dental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 11 Jul 2023 (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.
This study will be done to evaluate the impact of Biosmalto Impact Action Mousse™ on the development and healing of WSLs in individuals receiving orthodontic treatment.
The control group received a fluoridated toothpaste (Colgate toothpaste). The intervention group received Curasept toothpaste and additionally at each visit a Curasept Biosmalto Mousse was applied on the facial surface of the maxillary and mandibular anterior teeth using a tray.
For each patient recruited, identical toothbrushes and oral care instructions were given. The patients received instructions to brush their teeth for at least two minutes using an up-down motion on their anterior teeth and a circular motion on their posterior teeth at least three times/day.
Detailed description
This study is a multicenter randomized clinical trial with blinded parallel groups, simple randomization, an equal allocation ratio (1:1), and no stratification.The patients will be initially assessed for eligibility to be included in the study by the investigator.The study was verbally explained to those who fulfilled the inclusion criteria in order to get their first consent for participation. After that, they received the patient information sheet (Appendix), which explained the purpose of the research. The patients were instructed to thoroughly read the informational material at home and tell the researcher of their intention to participate at the next visit. Participants had to either sign the consent form (which was attached to the patient information sheet) or get their parents' permission (if the participant was under the age of 18 years). The investigator provided the patients with further information or reassurance about the trial if needed.
All the participants received a standardized treatment protocol. The patients were treated with straight wire appliance using metal brackets (3BOrtho, China). Initially, teeth polishing was performed with pumice and rubber cup for 10 seconds using a low-speed handpiece, followed by water rinsing and air drying (oil-free air spray for 30 seconds). Bonding technique was performed using 37% phosphoric acid for 30 seconds (Heinig and Hartmann, 2008b), then washed with water for 15-20 seconds, and dried for 10 seconds. A thin coat of primer was applied to the etched surfaces by an applicator and cured for 15 seconds by the LED light-curing unit. The brackets were bonded using similar adhesive (3B Ortho, white glue, China) and checked so that no obvious extra adhesive is remained on the tooth surface around the brackets. The control group received a fluoridated toothpaste (Colgate toothpaste). The intervention group received Curasept toothpaste and additionally at each visit a Curasept Biosmalto Mousse was applied on the facial surface of the maxillary and mandibular anterior teeth using a tray.
For each patient recruited, identical toothbrushes and oral care instructions were given. The patients received instructions to brush their teeth for at least two minutes using an up-down motion on their anterior teeth and a circular motion on their posterior teeth at least three times/day. Additionally, the patients were instructed not to use any additional antimicrobial-containing products (mouthwash, toothpaste, gel).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Combination Product: Curasept Biosmalto Mousse and toothpasteThe intervention group will receive Curasept toothpaste with instructions and additionally at each visit a Curasept Biosmalto Mousse will be applied on the facial surface of the maxillary and mandibular anterior teeth using a tray. |
| control group | Placebo comparator | Other: Colgate toothpasteThe control group will receive a fluoridated toothpaste (Colgate toothpaste) and instructed to brush at least three times/day. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Willingness to participate.
- No underlying medical conditions requiring medications that may cause dryness of the mouth.
- Fully erupted permanent maxillary and mandibular canines and incisors that have not been restored.
Key exclusion criteria (10 listed)
- Receiving professional fluoridation within the last three months.
- Untreated cavitated lesions or significant restorations on the facial surfaces of study teeth.
- Labial restoration of any of the study teeth.
- Missing any of the study teeth.
- Severely rotated any of the study teeth (limiting the appearance of buccal surfaces).
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 |
|---|---|---|
| Curasept Biosmalto Mousse and toothpasteat each visit a Curasept Biosmalto Mousse will be applied on the facial surface of the maxillary and mandibular anterior teeth using a tray. | Combination product | intervention group |
| Colgate toothpasteThe control group will receive a fluoridated toothpaste (Colgate toothpaste) | Other | control group |
Primary outcome
WSLs evaluation
Time frame: 6 month
To evaluate the number of WSLs on the labial surfaces of maxillary and mandibular anterior teeth using enamel white spot lesion index (WSLI), ICDAS (International caries detection and assessment system) and DIAGNOdent pen scores at each visit and after six months during orthodontic treatment. Gorelick Index : 0: no WSLs 1. Slight WSLs 2. extended or excessive WSLs 3. WSLs with cavitation DIAGNOdent pen reading: 0 - 10 Healthy Tooth Structure 11-20 Outer Half Enamel Caries 21-30 Inner Half Enamel Caries 30+ Dentin Caries
1 secondary outcome
amount of plaque and gingival bleeding
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Background: PubMed 17977295Andersson 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.
- Background: PubMed 17823680Ardu S, Castioni NV, Benbachir N, Krejci I. Minimally invasive treatment of white spot enamel lesions. Quintessence Int. 2007 Sep;38(8):633-6.
- Background: PubMed 15591733Boersma JG, van der Veen MH, Lagerweij MD, Bokhout B, Prahl-Andersen B. Caries prevalence measured with QLF after treatment with fixed orthodontic appliances: influencing factors. Caries Res. 2005 Jan-Feb;39(1):41-7. doi: 10.1159/000081655.
- Background: 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.
- Background: PubMed 22718979Du J, Yuan Y, Si T, Lian J, Zhao H. Customized optimization of metabolic pathways by combinatorial transcriptional engineering. Nucleic Acids Res. 2012 Oct;40(18):e142. doi: 10.1093/nar/gks549. Epub 2012 Jun 19.
- Background: PubMed 19897823Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.
- Background: PubMed 32051965Gizani S, Kloukos D, Papadimitriou A, Roumani T, Twetman S. Is Bleaching Effective in Managing Post-orthodontic White-spot Lesions? A Systematic Review. Oral Health Prev Dent. 2020 Feb 14;18(1):2-10. doi: 10.3290/j.ohpd.a44113.
- Background: PubMed 6758594Gorelick 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.
- Background: PubMed 30451901Iafisco M, Degli Esposti L, Ramirez-Rodriguez GB, Carella F, Gomez-Morales J, Ionescu AC, Brambilla E, Tampieri A, Delgado-Lopez JM. Fluoride-doped amorphous calcium phosphate nanoparticles as a promising biomimetic material for dental remineralization. Sci Rep. 2018 Nov 19;8(1):17016. doi: 10.1038/s41598-018-35258-x.
- Background: 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.
- Background: PubMed 21208070Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1.
- Derived from this study: PubMed 40657473Assim SH, Yassir YA. Effect of biomimetic tooth mousse and toothpaste on the incidence of white spot lesions during fixed appliance orthodontic treatment: A randomized clinical trial. J Taibah Univ Med Sci. 2025 Jun 25;20(3):405-416. doi: 10.1016/j.jtumed.2025.06.004. eCollection 2025 Jun.
- Individual participant dataSharing planned: No
Related trials for Enamel Hypomineralization, Dental
Not yet recruiting
Esthetic Impact of Different Minimally Invasive Approaches on Hypomineralized Permanent Anterior Teeth
Enamel Hypomineralization, Dental
Active, not recruiting
Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment
Molar Incisor Hypomineralization
Not yet recruiting
Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
Molar-Incisor Hypomineralization (MIH)
Recruiting
Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
Fluoride Varnishes, Molar Incisor Hypomineralisation
Recruiting
Molar-Incisor Hypomineralization and Resin Infiltration
Molar Incisor Hypomineralization
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 Curasept Biosmalto Mousse and toothpaste and Colgate toothpaste in people with Enamel Hypomineralization, Dental, run by University of Baghdad at 1 site in Iraq.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Jul 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 Iraq. 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. Some participants in this study may receive a placebo. 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?
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?
WSLs evaluation (time frame: 6 month). 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 NCT05940701, which also lists 12 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 11 Jul 2023.