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Alternative Treatment of Deep Carious Lesions Based on Biological Evidences

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ClinicalTrials.gov Identifier: NCT00973089
Recruitment Status : Withdrawn (recruiting or enrolling participants has halted prematurely and will not resume)
First Posted : September 9, 2009
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Moti Moskovitz, Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE September 6, 2009
First Posted Date  ICMJE September 9, 2009
Last Update Posted Date August 19, 2015
Study Start Date  ICMJE May 2010
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2009)
The success of the alternative treatment of the deep carious lesion. [ Time Frame: Half annually for three years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alternative Treatment of Deep Carious Lesions Based on Biological Evidences
Official Title  ICMJE Alternative Treatment of Deep Carious Lesions Based on Biological Evidences
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.
Detailed Description The treatment provided today for deep carious lesions in deciduous teeth is complete removal of the soft caries, that can lead to a wide preparation and need of tooth pulpotomy if the caries reaches to the pulp chamber, even if the tooth is asymptomatic and shows no signs of pulpal inflammation (neither clinically nor radiographically). According to a number of recent evidence based researches, and only in selected cases, dentists were able to preserve the vitality of the pulp without complete removal of the caries present near the pulp chamber. A thin layer of caries near the pulp chamber is left, and a liner is placed (conservative treatment). The carious process is stopped when the tooth is sealed, and thus the tooth is saved without engaging with pulpotomy and wide preparation of the tooth. The purpose of this study is to evaluate the success rate of the conservative treatment of deep carious lesions versus the treatment provided today that 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Caries, Dental
Intervention  ICMJE Other: Incomplete caries removal in primary teeth
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.
Other Name: Indirect pulp capping
Study Arms  ICMJE
  • No Intervention: Complete caries removal
    Control group
  • Incomplete caries removal
    Test group
    Intervention: Other: Incomplete caries removal in primary teeth
Publications * 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 18, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2009)
100
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Subjects that are not ASA I
  • Lack of cooperation
  • Clinical or radiographic signs of pathology
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00973089
Other Study ID Numbers  ICMJE LSA001-HMO-CTIL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Moti Moskovitz, Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hadassah Medical Organization
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP