NCT03563534

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

1.7 years

First QC Date

June 10, 2018

Last Update Submit

June 21, 2018

Conditions

Deep Caries

Keywords

Silver diamine fluoride, dental caries children

Outcome Measures

Primary Outcomes (1)

  • Absence of spontaneous pain (questionnaire)

    Direct questioning (yes/no)

    6 months

Secondary Outcomes (3)

  • Absence of pain on percussion (clinical examination)

    6 months

  • Absence of swelling (clinical examination)

    6 months

  • periapical radiograph

    6 months

Study Arms (2)

silver diamine fluoride

ACTIVE COMPARATOR

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

Drug: Silver Diamine Fluoride

interim restorative therapy

ACTIVE COMPARATOR

Resin modified glass ionomer applied to cavitated primary molars

Drug: Glass Ionomer

Interventions

Silver Diamine FluorideDRUG

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

silver diamine fluoride
Glass IonomerDRUG

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

interim restorative therapy

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Cairo University

Al Manyal, Cairo Governorate, 11562, Egypt

RECRUITING

MeSH Terms

Interventions

silver diamine fluorideglass ionomer

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

June 10, 2018

First Posted

June 20, 2018

Study Start

September 15, 2017

Primary Completion

June 1, 2019

Study Completion

September 1, 2019

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations

EG(1)