Comparison Between Rapid and Slow Palatal Expansion: Evaluation of Periodontal Indices

Sponsor
University of L'Aquila (Other)
Overall Status
Completed
CT.gov ID
NCT01888666
Collaborator
(none)
20
1

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the periodontal effects during rapid palatal expansion (RPE) or slow palatal expansion (SPE) and to compare them by means of periodontal indices, in order to establish the possible differences and advantages of one of these treatments in periodontal terms.

Materials and methods: 10 patients will selected and submitted to RPE treatment; other 10 patients will selected and submitted to SPE treatment. The patients will treated with the Haas appliance. In both the groups the periodontal clinical indices (plaque index, PI; papillary bleeding index, PBI; probing pocket depth, PPD) will collected three times during the treatment (before, during and at the end). All measurements will performed by the same examiner.

A descriptive statistical analysis will conducted. The paired samples Student's T test will used to evaluate the intra-group differences between t1 and t2. The unpaired samples Student's T test will used to evaluate between groups differences at t1 and t2. The significance level will set at 95%.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Jan 1, 2013
    Actual Primary Completion Date :
    Aug 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    rapid palatal expansion (RPE) using the Haas appliance

    slow palatal expansion (SPE)

    Outcome Measures

    Primary Outcome Measures

    1. evaluation of periodontal health by probing pocket depth, PPD [Change from Baseline in probing pocket depth at 20 days and 5 months of active therapy]

      In the Group I (RPE), probing pocket depth were detected in three stages: T0, detected 7 days after the periodontal prophylaxis (at the beginning of the active orthodontic therapy) ; T1, detected after 20 days of active therapy; T2, detected after 5 months of retention therapy. In the Group II, the collected data corresponded to: T0, detected 7 days after the periodontal prophylaxis; T1, detected during clinical control after 3 months of active therapy; T2, detected after 3 months of restraint. All measurements were performed by the same examiner.

    Secondary Outcome Measures

    1. valuation of periodontal health by plaque index, PI [Change from Baseline in plaque index at 20 days and 5 months of active therapy]

      In the Group I (RPE), plaque index were detected in three stages: T0, detected 7 days after the periodontal prophylaxis (at the beginning of the active orthodontic therapy) ; T1, detected after 20 days of active therapy; T2, detected after 5 months of retention therapy. In the Group II, the collected data corresponded to: T0, detected 7 days after the periodontal prophylaxis; T1, detected during clinical control after 3 months of active therapy; T2, detected after 3 months of restraint. All measurements were performed by the same examiner.

    2. evaluation of periodontal health by papillary bleeding index, PBI [Change from Baseline in papillary bleeding index at 20 days and 5 months of active therapy]

      In the Group I (RPE), papillary bleeding index were detected in three stages: T0, detected 7 days after the periodontal prophylaxis (at the beginning of the active orthodontic therapy) ; T1, detected after 20 days of active therapy; T2, detected after 5 months of retention therapy. In the Group II, the collected data corresponded to: T0, detected 7 days after the periodontal prophylaxis; T1, detected during clinical control after 3 months of active therapy; T2, detected after 3 months of restraint. All measurements were performed by the same examiner.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • palate narrow

    • necessity of performing a expansion treatment

    Exclusion Criteria:
    • dental disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept. of Life, Health and Environmental Science, University of L'Aquila L'Aquila AQ Italy 67100

    Sponsors and Collaborators

    • University of L'Aquila

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Enrico Marchetti, Contract professor, University of L'Aquila
    ClinicalTrials.gov Identifier:
    NCT01888666
    Other Study ID Numbers:
    • Tecc01/2013
    First Posted:
    Jun 28, 2013
    Last Update Posted:
    Aug 15, 2013
    Last Verified:
    Aug 1, 2013

    Study Results

    No Results Posted as of Aug 15, 2013