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Completed

NCT Number: NCT01888666

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

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%.

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Key information

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Life, Health and Environmental Science, University of L'Aquila

L’Aquila, AQ, 67100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • palate narrow
  • necessity of performing a expansion treatment

Exclusion criteria

  • dental disease

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of L'Aquila

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
First posted
Jun 28, 2013
Registry last updated
Aug 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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