Alternative Treatment of Deep Carious Lesions Based on Biological Evidences
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 6, 2009 | ||||
| Last Updated Date | July 21, 2012 | ||||
| Start Date ICMJE | May 2010 | ||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The success of the alternative treatment of the deep carious lesion. [ Time Frame: Half annually for three years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00973089 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | 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 | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 Arm (s) |
|
||||
| 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | April 2014 | ||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 5 Years to 8 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00973089 | ||||
| Other Study ID Numbers ICMJE | LSA001-HMO-CTIL | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Moti Moskovitz, Hadassah Medical Organization | ||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Hadassah Medical Organization | ||||
| Verification Date | July 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||