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Caries Arresting in Primary Molar Teeth Using SDF VS ART

NCT05188846 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-01-12

No results posted yet for this study

Summary

This study aimed to evaluate the oral health related quality of life ( OHRQoL), during caries management in children with vital carious primary teeth with no signs of irreversible pulpitis using SDF alone or SDF in combination with ART, using Early Childhood Oral Health Impact Scale (ECOHIS).

Conditions

  • Dental Caries

Interventions

OTHER

SDF

1\. Group 1: cleaning the occlusal surface to be treated with toothbrush. Decayed tissue from the affected teeth will not be removed for the SDF group. Clinical procedure for SDF application: it will apply according to the SDF manufacturer Instructions as follows:(1) the surrounding gingival tissues and lips will be protected with petroleum jelly to avoid staining and irritation,(2) the affected tooth will be isolated and keep dry with cotton rolls and saliva ejectors, (3) one drop of SDF (SDI RIVA STAR ), will be placed into a disposable dish, (4) SDF will be applied with a micro-sponge directly to the affected tooth surface(s), (5) allowed to soak in for 2 min, then air-dried. Then will be followed by the Potassium iodide (KI) liquid to decrease discoloration caused by SDF. The KI liquid will be reapplied until no more white perception observed to form.

OTHER

SDF + ART (SMART technique )

2\. Group 2: SDF+ART clinical procedure: (1)cleaning the occlusal surface to be treated with toothbrush.,(2) carious dentin will be removed using a small excavator (Spoon excavator ),(3) the cavity will be cleaned and dried, (4)cavity walls and floor will be conditioned for 10s, then washed and dried, (5) SDF will be applied as mentioned above followed by cavity restoration using resin-reinforced glass ionomer restorative material (SDI RIVA ).

Sponsors & Collaborators

  • Ola Adel Abdelfadil Ahmed

    lead OTHER

Principal Investigators

  • Nevine Waly, Professor · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2023-01-31
Completion
2023-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05188846 on ClinicalTrials.gov