Treatment of Primary Molars With Deep Caries Using Silver Diamine Fluoride

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03563534
Collaborator
(none)
20
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2
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Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Silver Diamine Fluoride
  • Drug: Glass Ionomer
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Post-operative Pain After Silver Diamine Fluoride Application in Primary Molars With Deep Caries Versus Interim Restorative Therapy
Actual Study Start Date :
Sep 15, 2017
Anticipated Primary Completion Date :
Jun 1, 2019
Anticipated Study Completion Date :
Sep 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Absence of spontaneous pain (questionnaire) [6 months]

    Direct questioning (yes/no)

Secondary Outcome Measures

  1. Absence of pain on percussion (clinical examination) [6 months]

    Applying pressure by finger (yes/no)

  2. Absence of swelling (clinical examination) [6 months]

    Visual examination (yes/no)

  3. periapical radiograph [6 months]

    absence of periapical radiolucency

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry Cairo University Al Manyal Cairo Egypt 11562

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Manar Motawie Abdulfattah, principle investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT03563534
Other Study ID Numbers:
  • CEBD-CU-2018-06-44
First Posted:
Jun 20, 2018
Last Update Posted:
Jun 26, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Keywords provided by Manar Motawie Abdulfattah, principle investigator, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2018