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

August 14, 2013 updated by: Enrico Marchetti, University of L'Aquila

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%.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • AQ
      • L'Aquila, AQ, Italy, 67100
        • Dept. of Life, Health and Environmental Science, University of L'Aquila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients attending the division of orthodontics of Department MeSVA, University of L'Aquila, Italy

Description

Inclusion Criteria:

  • palate narrow
  • necessity of performing a expansion treatment

Exclusion Criteria:

  • dental disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

Change from Baseline in probing pocket depth at 20 days and 5 months of active therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

Change from Baseline in plaque index at 20 days and 5 months of active therapy
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.

Change from Baseline in papillary bleeding index at 20 days and 5 months of active therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (Estimate)

June 28, 2013

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 14, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • Tecc01/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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