Treatment of Primary Molars With Deep Caries Using Silver Diamine Fluoride

Post-operative Pain After Silver Diamine Fluoride Application in Primary Molars With Deep Caries Versus Interim Restorative Therapy

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).

Study Overview

• Status: Unknown
• Conditions: Deep Caries
• Intervention / Treatment: Drug: Silver Diamine Fluoride; Drug: Glass Ionomer

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Al Manyal, Cairo, Egypt, 11562
      • Recruiting
      • Faculty of Dentistry cairo university
      • Contact: manar abdulfattah, BSC; Phone Number: 01229032525; Email: manar.motawie@dentistry.cu.edu.eg
      • Contact: sara mahmoud, PHD
      • Principal Investigator: manar abdulfattah, BSC
      • Sub-Investigator: sara mahmoud, PHD
      • Sub-Investigator: soad Abdel moniem, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of spontaneous pain (questionnaire)	Direct questioning (yes/no)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of pain on percussion (clinical examination)	Applying pressure by finger (yes/no)	6 months
Absence of swelling (clinical examination)	Visual examination (yes/no)	6 months
periapical radiograph	absence of periapical radiolucency	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2017
• Primary Completion (ANTICIPATED): June 1, 2019
• Study Completion (ANTICIPATED): September 1, 2019

Study Registration Dates

• First Submitted: June 10, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (ACTUAL): June 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 21, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Silver diamine fluoride, dental caries children
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: CEBD-CU-2018-06-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes