Efficacy of Silver Diamine Fluoride and Its Parental Perception
Klíčová slova
Abstraktní
Popis
The present randomized clinical study is aiming to evaluate the effectiveness of silver diamine fluoride (SDF) in arresting dentin caries lesions when compared to MI Varnish a 5% sodium fluoride varnish which also contains RECALDENT™* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate. For this, healthy children aged 4-8 years with at least one active dentin carious lesion will be allocated randomly to one of two treatment groups: Group (1) SDF and Group (2) MI Varnish. Each participant will be assigned to one treatment group to avoid the possible synergistic effect of the different agents.
Parents/ guardians of each child will be fully informed regarding the study design, objectives and probable advantages and side effects especially the black discoloration of SDF before their involvement by written consent. The International Caries Detection and Assessment System (ICDAS II) will be used to determine caries diagnosis and activity.visual and tactile examination will be done with a WHO probe to assess the primary outcome. the secondary outcome will be conducted by a questionnaire given to the parents.
Termíny
| Poslední ověření: | 02/29/2020 |
| První předloženo: | 12/17/2019 |
| Odhadovaná registrace vložena: | 12/26/2019 |
| První zveřejnění: | 12/29/2019 |
| Poslední aktualizace byla odeslána: | 03/23/2020 |
| Poslední aktualizace zveřejněna: | 03/25/2020 |
| Aktuální datum zahájení studie: | 01/20/2020 |
| Odhadované datum dokončení primární: | 10/19/2020 |
| Odhadované datum dokončení studie: | 12/19/2020 |
Stav nebo nemoc
Intervence / léčba
Drug: Group 1: topical application of silver diamine fluoride
Drug: Group 2: topical application of MI varnish.
Fáze
Skupiny zbraní
| Paže | Intervence / léčba |
|---|---|
| Experimental: Group 1: topical application of silver diamine fluoride 38% silver diamine fluoride liquid | Drug: Group 1: topical application of silver diamine fluoride 38% silver diamine fluoride liquid will be applied with a brush |
| Active Comparator: Group 2: topical application of MI varnish. MI Varnish:5% sodium fluoride varnish which also contains RECALDENT™* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate | Drug: Group 2: topical application of MI varnish. topical fluoride varnish with calcium and phosphate |
Kritéria způsobilosti
| Věky způsobilé ke studiu | 4 Years Na 4 Years |
| Pohlaví způsobilá ke studiu | All |
| Přijímá zdravé dobrovolníky | Ano |
| Kritéria | Inclusion Criteria: 1. Normal healthy children without any systemic disease ASA 1 physical status. 2. Children with at least one carious dentin lesion in their primary teeth, code 5 (ICDAS II) Exclusion Criteria: 1. Children who suffer from major systemic diseases and require long term medications. 2. Children refuse the study intervention. 3. Children with silver or milk product sensitivity. 4. Presence of any gingival or perioral ulceration or stomatitis. 5. Tooth with abscess, fistula or severe pain. |
Výsledek
Primární výsledná opatření
1. caries arrestment [2 weeks]
Měření sekundárních výsledků
1. Parent perception [0 - 2 weeks]
