Treatment of Primary Molars With Deep Caries Using Silver Diamine Fluoride

NCT ID: NCT03563534

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2019-09-30

Brief Summary

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).

Detailed Description

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.

Conditions

Deep Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

silver diamine fluoride

38% silver diamine fluoride applied to cavitated primary molars twice per week to arrest caries

Group Type: ACTIVE_COMPARATOR

Silver Diamine Fluoride

Intervention Type: DRUG

Margins of cavitated lesion(s) will be excavated.The carious teeth will be isolated, kept dry, and apply 38% silver diamine fluoride.

interim restorative therapy

Resin modified glass ionomer applied to cavitated primary molars

Group Type: ACTIVE_COMPARATOR

Glass Ionomer

Intervention Type: DRUG

Margins of cavitated lesion(s) will be excavated.The carious teeth will be isolated, kept dry, apply resin modified glass ionomer.

Interventions

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.

Intervention Type: DRUG

Glass Ionomer

Margins of cavitated lesion(s) will be excavated.The carious teeth will be isolated, kept dry, apply resin modified glass ionomer.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Manar Motawie Abdulfattah

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry Cairo University

Al Manyal, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

manar abdulfattah, BSC

Role: primary

manar.motawie@dentistry.cu.edu.eg

01229032525

sara mahmoud, PHD

Role: backup

Other Identifiers

CEBD-CU-2018-06-44

Identifier Type: -

Identifier Source: org_study_id