Effectiveness of placing crowns without tooth preparation and removing decay

Not yet recruiting

Conditions: Children with dental caries

Registration Number: CTRI/2019/06/019831

Lead Sponsor: Three M

Brief Summary: Stainless steel crowns have beenrecommended in the literature as restorative material of choice in primarymolars with multi surface caries involvement, following pulp therapy and inchildren at high risk of dental caries. It has been considered most costeffective since they donâ€™t require frequent replacement. Generally stainlesssteel crowns are considered in the following situation: high risk patients withsingle surface/ multi surface caries/ demineralization under eight years ofage; after pulp therapy; teeth with extreme wear facets and more than two yearsbefore exfoliation. Despite SSC being recommended as the ideal restoration formanaging primary molar where caries involves two or more surfaces and evidenceof their effectiveness, SSC are not widely used. The standard techniques involvestooth preparation under local anesthesia which was not widely accepted by thepreschool children. This lead to a novel simplified method of using SSC, theHall Technique being investigated. This method uses SSC which are filled withAntidecay cement (GIC) and simply pushed onto the tooth with no caries removalor tooth preparation. Efficient sealing / cementing enhances the success ofrestoration by preventing bacterial ingress and further progress of the lesion.With the Hall Technique, the process of fitting the crown is quick andnon-invasive. The crown is seated over the tooth with no caries removal ortooth preparation of any kind, and local anesthesia is not required. By doing this technique there willbe no impact to developing tooth, if any caries left untreated which will haveimpact over the developing permanent tooth, so based on the extend of thecaries they need to be treated either as restoration or with SSC. There is norisk for doing this procedure in children, this makes the child morecomfortable for the procedure.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 220

Inclusion Criteria

1.Participants aged 3 to 8 years of age 2.
No relevant medical history 3.
No symptoms of reversible pulpitis (Pain on eating) 4.
OPG or Bitewings, IOPA radiographs available 5.
No inter-radicular radiolucency on the selected primary molar tooth.

Exclusion Criteria

Participants with special healthcare needs and developmental anomalies.
Caries involving pulp.
Radiographically radiolucency extending beyond a middle third of dentine.
Previous symptoms of nocturnal pain, inter-radicular radiolucency.
Clinical signs or symptoms of irreversible pulpitis, dental abscess or mobility.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clincial effectiveness and acceptability of the Hall Technique in young children between 3 to 8 years	Thirty Six months

Secondary Outcome Measures

Name	Time	Method
Lifespan of Stainless Steel crown with Halls Technique	Thirty Six months

Trial Locations

Locations (1): Sri Ramachandra Institute of Higher Education and Research
🇮🇳
Thiruvallur, TAMIL NADU, India
Sri Ramachandra Institute of Higher Education and Research
🇮🇳Thiruvallur, TAMIL NADU, India
Dr A Balamurugan
Principal investigator
8056044576
balafo@sriramachandra.edu.in