Alternative Treatment of Deep Carious Lesions Based on Biological Evidences

This study is currently recruiting participants.
Verified July 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Moti Moskovitz, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00973089
First received: September 6, 2009
Last updated: July 21, 2012
Last verified: July 2012

September 6, 2009
July 21, 2012
May 2010
May 2013   (final data collection date for primary outcome measure)
The success of the alternative treatment of the deep carious lesion. [ Time Frame: Half annually for three years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00973089 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Alternative Treatment of Deep Carious Lesions Based on Biological Evidences
Alternative Treatment of Deep Carious Lesions Based on Biological Evidences

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Caries, Dental
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
  • No Intervention: Complete caries removal
    Control group
  • Incomplete caries removal
    Test group
    Intervention: Other: Incomplete caries removal in primary teeth
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.
 
Recruiting
100
April 2014
May 2013   (final data collection date for primary outcome measure)

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
Both
5 Years to 8 Years
Yes
Contact: Moti Moskovitz, DMD PhD motim@md.huji.ac.il
Israel
 
NCT00973089
LSA001-HMO-CTIL
Yes
Moti Moskovitz, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Not Provided
Hadassah Medical Organization
July 2012

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