Study Stopped
recruiting or enrolling participants has halted prematurely and will not resume
Alternative Treatment of Deep Carious Lesions Based on Biological Evidences
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to evaluate the success rate of alternative treatment of deep carious lesions in asymptomatic primary teeth with no clinical nor radiographic signs of pulpal inflammation. The treatment includes leaving a thin layer of caries that is present near the pulp chamber and includes liner placement and tooth sealing. This alternative treatment is to be compared with the treatment provided today to these teeth, which includes complete removal of caries and probably includes pulpotomy and wide preparation of the tooth. The study also evaluates the cost-effectiveness of both methods of treatment of deep carious lesions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2009
CompletedFirst Posted
Study publicly available on registry
September 9, 2009
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedAugust 19, 2015
August 1, 2015
4.8 years
September 6, 2009
August 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The success of the alternative treatment of the deep carious lesion.
Half annually for three years
Study Arms (2)
Complete caries removal
NO INTERVENTIONControl group
Incomplete caries removal
OTHERTest group
Interventions
Comparison between the success rate and cost-effectiveness of complete caries removal in treatment of deep carious lesions that might include wide preparations and involve pulpotomy versus incomplete removal of caries and avoiding pulp treatment.
Eligibility Criteria
You may qualify if:
- Healthy children
- Patient's age is 5-8 years old at the time of the treatment
- Primary molars presenting with deep carious lesions
- Carious lesion reaching the inner half of the dentin,with absence of periapical or interradicular alterations as detected by radiographic examination.
- Absence of spontaneous pain
You may not qualify if:
- Subjects that are not ASA I
- Lack of cooperation
- Clinical or radiographic signs of pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Organization
Jerusalem, Israel
Related Publications (1)
Thompson V, Craig RG, Curro FA, Green WS, Ship JA. Treatment of deep carious lesions by complete excavation or partial removal: a critical review. J Am Dent Assoc. 2008 Jun;139(6):705-12. doi: 10.14219/jada.archive.2008.0252.
PMID: 18519994BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Senior Lecturer
Study Record Dates
First Submitted
September 6, 2009
First Posted
September 9, 2009
Study Start
May 1, 2010
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
August 19, 2015
Record last verified: 2015-08