Clinical trial NCT04889196: The Efficiency and Gingival Health Status of Hall Versus SDF Techniques in the Management of Carious Primary Molars
Official title: The Efficiency and Gingival Health Status of Hall Versus SDF Techniques in the Management of Carious Primary Molars: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PICO question:

In Comparison to the hall technique , will silver diamine fluoride have equalvent gingival health status in treatment of carious primary molars?

population: children suffering from caries . intervention : silver diamine fluoride. comparison: hall technique outcome:

Primary outcome:

Gingival health measurement device modified gingival index, measurement unit score(0-1-2)

Secondary outcomes:

1. Oral hygiene measurement device modified plaque index , measurement unit score (0-1-2)
2. Time of Treatment measurement device digital chronometer, measurement unit minutes

Detailed description: Dental caries, also known as tooth decay, it can occur in primary teeth in early childhood, is formed through interaction between acid-producing bacteria and carbohydrate. The caries develops in both the crowns and roots of teeth. Progress of caries depended on the lifestyle of the child (as high numbers of cariogenic bacteria, inadequate salivary flow, insufficient fluoride exposure and poor oral hygiene). To avoid this disease should follow the proper oral hygiene and improve lifestyle . A lot of methods found to treatment the decayed tooth - like; Hall technique and Silver diamine fluoride The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method

Previous studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC)

Eligibility criteria: Inclusion Criteria:

* Age: From 4 to 6 years
* Clinical diagnosis of tooth with caries in primary molars within enamel or dentin without pulp disease

Exclusion Criteria:

* Tooth with signs and symptoms of pulp necrosis
* Tooth with Root caries
* Tooth with Spontaneous pain

Primary outcomes:
measure: Gingival health
timeFrame: up to 1 day
measure: Gingival health
timeFrame: at 3 months
measure: Gingival health
timeFrame: at 6 months
Secondary outcomes:
measure: Oral hygiene
timeFrame: up to one day
measure: Oral hygiene
timeFrame: at 3 months
measure: Oral hygiene
timeFrame: at 6 months
measure: Treatment time
timeFrame: during procedure
measure: Treatment time
timeFrame: during procedure in the second application at 6 monthes
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: sherif B Eltaeil, Prof
role: STUDY_CHAIR
References:
citation: Elamin F, Abdelazeem N, Salah I, Mirghani Y, Wong F. A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan. PLoS One. 2019 Jun 3;14(6):e0217740. doi: 10.1371/journal.pone.0217740. eCollection 2019.