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Effect of a caries paralyzing substance on deep cavities of milk molars compared to a caries obturator treatment

Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3ndqws
Enrollment
Unknown
Registered
2017-08-02
Start date
2016-09-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Tooth,Deciduous, Cariostatic Agents, Dental Atraumatic Restorative Treatment, Glass Ionomer Cements

Interventions

118 healthy children aged 2-5 years with at least one caries lesion on occlusal faces of primary molars with no signs of pain or pulp involvement after clinical and radiographic examination will be r
(B) relative isolation with cotton roll and saliva-sucker
(C) removal of the carious tissue from the enamel-dentin junction prior to removing from the bottom of the cavity
Only the softened tissue should be removed. A cavity size compatible dentin excavator will be used
(D) cleaning of the cavity and the occlusal surface with cotton ball soaked in water
(E) surface conditioning with the liquid of the glass ionomer cement (Ketac Molar Easy Mix 3M ESPE) for 10 seconds with the aid of a cotton ball
(F) washing the surface with cotton ball soaked in water
(G) surface drying with dry cotton ball
(H) manipulation the cement according to the manufacturer's instructions
(I) insertion of the cement into the cavity, instrument manual
(J) digital pressure with petroleum jelly for 30 seconds
(K) checking the occlusion and removing excess, when necessary, with the manual instrument
(L) filling coverage with petroleum jelly
(M) instructions to stay 1 hour without feeding (FRENCHEN et al., 1996). As lesions of the DFP group are treated according to the
Procedure/surgery
D01.248.497.158.380

Sponsors

Universidade Federal do Rio de Janeiro
Lead Sponsor
Universidade Federal do Rio de Janeiro
Collaborator

Eligibility

Age
2 Years to 5 Years

Inclusion criteria

Inclusion criteria: Children aged 2 to 5 years;who are in good general health;who have at least one active dentin carious lesion on the occlusal surface of primary molars corresponding to ICDAS codes 5 or 6.

Exclusion criteria

Exclusion criteria: Children with systemic or neurological diseases;whose families intend to move from Rio de Janeiro next year;with a history of allergy to silver or any substance present in the different materials to be used for treatment. Besides that, teeth with spontaneous or provoked pain, dental mobility or radiographic signs of involvement or possible pulp involvement;shows possible pulp involvement by radiographic examination.

Design outcomes

Primary

MeasureTime frame
In the follow up, the clinical examination will be performed by a different examiner than the one who performed the initial examination and blinded the study.All the teeth of each child will be evaluated in the same way as in the initial examination.Thus, comparing the data from the initial examination to those from the review, one researcher will rate the study tooth for success or failure according to the treatment group.Test group; success: when there is caries arrest (ICDAS) and failure: when there is no caries arrest (ICDAS).At the 6-month follow-up, SDF will be reapplied on all the teeth included in this group,with no signs and symptoms of pulp involvement.In the Control Group; Success: when there is caries arrest (ICDAS). If the restoration is present, without apparent dentin, it will be considered as arrested, since it will be closed (KIDD, 2012). If the dentine is exposed but arrested, it will be considered success, the restoration will be replaced and the registration will be done and failure: when there is no caries arrest (ICDAS).Then the proportion (percentage) of caries lesions that become inactive (arrested) in the test group, compared to the control group, will be calculated.The follow up reviews will be performed after 3, 6, 12, 18, 24., 30 and 36 months.

Secondary

MeasureTime frame
1 - A scale of facial images (BUCHANAN & .NIVEN, 2002) will be used to assess the degree of anxiety of children aged 3 years and over, before and after the first examination and treatment appointment.Thus, a change in anxiety (positive change, no change, or a negative change) will be assessed through a possible variation observed between moments (before and immediately after treatment). 2-Information on aesthetic perception will be obtained through the questionnaire Child's and Parent's Questionnaire about Teeth Appearance, applied to those responsible in the initial consultation, and in the reviews of 3, 6 and 12 months.Thus, we will evaluate if there was a change in the aesthetic perception from the viewpoint of the responsible, comparing the results of before and after the treatment. 3-Information about the quality of life will be obtained through the questionnaire B-ECOHIS (SCARPELLI et al., 2011) in the initial consultation, after 14 days (ABANTO et al., 2015) and 90 days of treatment received.Thus, we will evaluate if there was a change in the quality of life of the child and the family, comparing the results of before and after treatment.

Countries

Brazil

Contacts

Public ContactAna Lucia Vollu

Universidade Federal do Rio de Janeiro

avollu@terra.com.br55(21)39382098

Outcome results

None listed

Source: REBEC (via WHO ICTRP)