Comparing Two Brands of Silver Diamine Fluoride for Stopping Cavities in Children (SDF)
Comparative Study of Two Different Marketed Brands of Silver Diamine Fluoride SDF in Arresting Dental Caries in Children (Randomized Control Trial)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Before application of SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. SDF in both groups will be applied directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes.
All children will be recalled after 6 and 12 months for follow up.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Cairo Governorate
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Cairo, Cairo Governorate, Egypten, 12572
- National Research Centre
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Children who are apparently healthy with primary carious teeth aged from 4-7 years.
- Uncooperative children.
- Children with financial barrier in accessing dental care
- Clinically: absence of any pathology or pain except of sensitivity with eating.
- Parents and patients accepting the new treatment modality and parents assigned the informed consent.
Exclusion Criteria:
- Known sensitivity to silver or other heavy-metal ions.
- Children who will not comply to recall program.
- Teeth with pulp involvement.
- Tooth mobility (more than grade 1 (grade 1:1-2 mm tooth mobility).
- History of pain for a long period of time that may indicate chronic pulp inflammation.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: SDF, ToothMate®, Egypt.
Egyptian manufactured SDF, 38% silver diamine fluoride is applied. Before application of tooth mate SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. Tooth mate SDF will be applied by bond brush directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes. All children will be recalled after 6 and 12 months for follow up |
38% silver diamine fluoride manufactured in Egypt
38% silver diamine fluoride , manufactured in USA
|
|
Aktiv komparator: SDF, Advantage arrest®, USA
USA manufactured SDF, 38% silver diamine fluoride. Before application of Advantage arrest SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. Advantage arrest SDF will be applied by bond brush directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes. All children will be recalled after 6 and 12 months for follow up |
38% silver diamine fluoride manufactured in Egypt
38% silver diamine fluoride , manufactured in USA
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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number of tooth with arrested caries in each group
Tidsramme: 12 months
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Arrest of caries through:
|
12 months
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0341
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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