Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
A Pilot Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
Mintech-Bio Ltd is a UK-based start-up company which was created to turn 14 years of research from our co-founder Dr Alvaro Mata at Queen Mary University into a real-world product.
Loss of tooth enamel from issues such as decay or erosion is a great cause of dental problems, affecting over half of people around the world. There is also evidence to suggest that having poor oral health may be connected to other health issues such as diabetes, heart problems, and lung infections like pneumonia.
While treatments like fluoride varnishes and remineralization solutions can help with the effects of enamel loss, there's currently no easy-to-use option that actually regrows enamel in a way that closely matches the natural look and strength of real enamel.
Mintech-Bio has created a special gel that helps rebuild tooth enamel back to its natural strength and structure. This new invention could take the place of fluoride treatments and make a big difference in preventing tooth problems around the world. The purpose of this research study is to demonstrate the efficacy of the Epinamel device in the treatment of dental white-spot lesions.
If you meet all the screening criteria you will be entered into the study and shall have the device applied after the removal of dental braces. Each trial participant will have the treatment product applied to a tooth on one side of the mouth, and a comparative 'control' product named Curodont Repair (vVardis Professional, Switzerland will be applied on the opposite side of the mouth.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Christina Clinical Consultant
- Telefonnummer: +44 7541619940
- E-post: christina@cslifesciences.com
Studiesteder
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London, Storbritannia, SE1 9RT
- Rekruttering
- Guys and St Thomas NHS Foundation Trust Faculty of Dentistry, Oral & Craniofacial Sciences, Kings College London
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Ta kontakt med:
- Avijiit Professor of Cariology & Operative Dentistry
- Telefonnummer: +44 207 1881577
- E-post: avijit.banerjee@kcl.ac.uk
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
• Will have dental braces or brackets removed immediately prior to or up to 48 hours prior to potential study participation
- Have at least one active non-cavitated carious lesions around the bracket area with a rough, chalky and matte surface (white spot lesions - WSLs) at each side of the mouth;
- Have carious lesion which are fully visible, assessable and accessible;
- Are able and willing to observe good oral hygiene throughout the study;
- Have ≥20 teeth and a BPE score of <3;
- Have completed fixed orthodontic treatment within the past 24-120 hours.
- Are aged 12-60 years
- Are willing and able to attend the on-study visits;
- Are willing and able to understand all study-related procedures;
- Provide written informed consent (by parent/guardian if minor) before participation in the study.
- No systemic diseases or concomitant medication affects salivary flow in order not to negatively affect the remineralising process.
Exclusion Criteria:
• Patients with known hypersensitivity to glutaraldehyde or any of the product's ingredients.
- Patients with severe pulpitis or oral infections
- Patients who are still be undergoing treatment using dental braces or brackets at time of study initiation
- Patients who are vulnerable
- Patients who are participating in another trial
- Patients with tetracycline pigmentation, dental fluorosis, or enamel hypoplasia
- Participants who had evidence of reduced salivary flow, systemic, or medical complications
- Participants with cavitated lesions
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Treatment group
Epinamel one side of mouth Curadont opposite side of mouth
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Epinamel is a professional dental product that is indicated for the treatment of white spot lesions. It utilizes a patented technology that promotes enamel repair by entrapping calcium and phosphate from the saliva to grow hydroxyapatite mineral within the white spot lesion and on the tooth surface. Epinamel is a 2-part product. Applying and drying Part A on the surface of the tooth followed by Part B initiates the hardening and setting of the product. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Regression or progression of white spot lesions (WSLs), determined by changes in lesion size measured (micrometers) by morphometry.
Tidsramme: 6 weeks
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Classified as the proportion of lesions that: Regress (decrease in size by >20% at 6 weeks with respect to baseline), Progress (increase in size by >20% at 6 weeks with respect to baseline), or Remain approximately stable in size (decrease or increase in size by ≤20% at 6 weeks with respect to baseline). Assessment method: Morphometric measurement (micrometers) of standardized, calibrated clinical photographs. |
6 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Laser Fluorescence Readings (DIAGNOdent Pen, KaVo, Biberach, Germany) Objective fluorescence-based assessment of lesion status.
Tidsramme: 6 weeks
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Repeat measurements will be used to monitor lesion progression or regression over time. Numerical values range from 0 to 99, with clinical interpretation as follows: 0-12: Healthy tooth structure / sound enamel 13-24: Initial enamel caries / demineralization 25-29: Deep enamel caries, possible dentin involvement ≥30: Likely dentin caries / advanced lesion A two-sided paired samples t-test will be used to compare laser fluorescence measurements at baseline and 6 weeks following treatment. A p-value of <0.05 will be considered statistically significant |
6 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CIP01_Rev01
- 10072636 (Annet stipend/finansieringsnummer: Innovate UK)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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