Deep Caries Clinical Trial
Official title:
Post-operative Pain After Silver Diamine Fluoride Application in Primary Molars With Deep Caries Versus Interim Restorative Therapy
Verified date | June 2018 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Recruiting |
Enrollment | 20 |
Est. completion date | September 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 6 Years |
Eligibility |
Inclusion Criteria: - CHILDREN - Aged 4 to 6 years. - in good general health. - TEETH o Have at least one active dentin carious lesion on the occlusal surface of primary molars corresponding to ICDAS* codes 5 or 6*. - PREOPERATIVE RADIOGRAPH - Absence of periapical infection. - No root resorption. - Normal periodontal ligament space. Exclusion Criteria: - CHILDREN - With systemic or neurological diseases. - With a history of allergy to silver or any substance present in the different materials to be used for treatment. - Unable to attend follow-up visits. TEETH - With spontaneous pain, mobility or radiographic signs of pulpal or periapical infection. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry Cairo University | Al Manyal | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absence of spontaneous pain (questionnaire) | Direct questioning (yes/no) | 6 months | |
Secondary | Absence of pain on percussion (clinical examination) | Applying pressure by finger (yes/no) | 6 months | |
Secondary | Absence of swelling (clinical examination) | Visual examination (yes/no) | 6 months | |
Secondary | periapical radiograph | absence of periapical radiolucency | 6 months |
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