Treatment of Primary Molars With Deep Caries Using Silver Diamine Fluoride
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|ClinicalTrials.gov Identifier: NCT03563534|
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : June 25, 2018
Untreated dental caries is a worldwide pandemic (Edelstein, 2006). Due to limited financial resources, poor access to basic oral care, and the high cost of restorative treatment, children of low-income nations have their general health, social well-being, and education opportunities affected by untreated dental caries (Baelum et al., 2007).
Traditional treatment of cavitated dentin lesions advocates complete removal of the decayed structure, i.e. the infected and affected dentin layers. During this procedure, however, a significant quantity of the dental structure is removed, and the pulp tissue may be exposed. In light of this, the complete removal of all decayed structures from a tooth with cavitated lesions is no longer seen as mandatory, as this increases the chance of pulp exposure, post-operative pain and weakens the tooth structure, and there is growing evidence to support incomplete removal of decayed tissue prior to the restoration of the cavity. It is argued, however, that carious lesions remaining in the cavity must be completely sealed in order to prevent their progression (Yee et al., 2009).
Arresting Caries Treatment (ACT) has been proposed to oversee untreated dental caries in children of disadvantaged communities. Treatment of carious lesions based on minimally invasive technique methods aim to prevent their progression and preserve pulp vitality by means of standards of anticipation, remineralization and minimal intervention in the dental tissue (Bedi and Sardo-Infirri, 1999).
|Condition or disease||Intervention/treatment||Phase|
|Deep Caries||Drug: Silver Diamine Fluoride Drug: Glass Ionomer||Phase 4|
A treatment option has been proposed in the last decade, based on the change in understanding of carious biofilm development and caries progression. Sealing carious dentine beneath a restoration deprives the caries biofilm of nutrients and alters the environment sufficiently to slow or arrest lesion progression. This has the added benefit of avoiding pulp exposure and subsequent treatment (Santamaria, Innes, Machiulskiene, Evans, & Splieth, 2014).
There is no clear evidence that leaving soft infected dentine, before sealing the cavity, is deleterious. Instead, this may prevent pulp exposure, preserve the pulp vitality, reduce the permeability of the remaining dentine by stimulating tertiary dentine formation, and so change the environment for the remaining microorganisms and thus arresting caries process. Silver diamine fluoride (SDF), Ag(NH3)2F, has been used to arrest caries since 1969.Silver Diamine Fluoride is a topical drug that is applied clinically to control active dental caries and prevent further progression of disease. Although, the ideal way to treat teeth with decay is removal of the decay and placing a restoration, this alternative treatment allows us to stop decay with non-invasive methods, especially with young children that have primary teeth. Treatment with Silver Diamine Fluoride does not eliminate the need for restorative dentistry to repair function or aesthetics, but has been effective at prevention of further decay.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Post-operative Pain After Silver Diamine Fluoride Application in Primary Molars With Deep Caries Versus Interim Restorative Therapy|
|Actual Study Start Date :||September 15, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||September 2019|
Active Comparator: silver diamine fluoride
38% silver diamine fluoride applied to cavitated primary molars twice per week to arrest caries
Drug: Silver Diamine Fluoride
Margins of cavitated lesion(s) will be excavated.The carious teeth will be isolated, kept dry, and apply 38% silver diamine fluoride.
Active Comparator: interim restorative therapy
Resin modified glass ionomer applied to cavitated primary molars
Drug: Glass Ionomer
Margins of cavitated lesion(s) will be excavated.The carious teeth will be isolated, kept dry, apply resin modified glass ionomer.
- Absence of spontaneous pain (questionnaire) [ Time Frame: 6 months ]Direct questioning (yes/no)
- Absence of pain on percussion (clinical examination) [ Time Frame: 6 months ]Applying pressure by finger (yes/no)
- Absence of swelling (clinical examination) [ Time Frame: 6 months ]Visual examination (yes/no)
- periapical radiograph [ Time Frame: 6 months ]absence of periapical radiolucency
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563534
|Faculty of Dentistry Cairo University||Recruiting|
|Al Manyal, Cairo, Egypt, 11562|
|Contact: manar abdulfattah, BSC 01229032525 email@example.com|
|Contact: sara mahmoud, PHD|
|Principal Investigator: manar abdulfattah, BSC|
|Sub-Investigator: sara mahmoud, PHD|
|Sub-Investigator: soad Abdel moniem, PHD|