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Alternative Treatment of Deep Carious Lesions Based on Biological Evidences

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00973089
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
58
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Incomplete caries removal in primary teeth
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Alternative Treatment of Deep Carious Lesions Based on Biological Evidences
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Complete caries removal

Control group
Other: Incomplete caries removal

Test group

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 Names:
  • Indirect pulp capping

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The success of the alternative treatment of the deep carious lesion. [Half annually for three years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 8 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hadassah Medical Organization Jerusalem Israel

    Sponsors and Collaborators

    • Hadassah Medical Organization

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Moti Moskovitz, Clinical Senior Lecturer, Hadassah Medical Organization
    ClinicalTrials.gov Identifier:
    NCT00973089
    Other Study ID Numbers:
    • LSA001-HMO-CTIL
    First Posted:
    Sep 9, 2009
    Last Update Posted:
    Aug 19, 2015
    Last Verified:
    Aug 1, 2015
    Keywords provided by Moti Moskovitz, Clinical Senior Lecturer, Hadassah Medical Organization
    Primary tooth
    Caries, Dental
    Alternative treatment
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of Aug 19, 2015