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

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ClinicalTrials.gov Identifier: NCT01888666
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : August 15, 2013
Sponsor:
Information provided by (Responsible Party):
Enrico Marchetti, University of L'Aquila

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
Palatal Expansion Technique

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2013
Actual Primary Completion Date : August 2013

Group/Cohort
rapid palatal expansion (RPE) using the Haas appliance
slow palatal expansion (SPE)



Primary Outcome Measures :
  1. evaluation of periodontal health by probing pocket depth, PPD [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.




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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients attending the division of orthodontics of Department MeSVA, University of L'Aquila, Italy
Criteria

Inclusion Criteria:

  • palate narrow
  • necessity of performing a expansion treatment

Exclusion Criteria:

  • dental disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888666


Locations
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Italy
Dept. of Life, Health and Environmental Science, University of L'Aquila
L'Aquila, AQ, Italy, 67100
Sponsors and Collaborators
University of L'Aquila
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Responsible Party: Enrico Marchetti, Contract professor, University of L'Aquila
ClinicalTrials.gov Identifier: NCT01888666    
Other Study ID Numbers: Tecc01/2013
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: August 15, 2013
Last Verified: August 2013