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

NCT01888666 | Completed

• 1 other identifier: Tecc01/2013
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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%.

Conditions

Palatal Expansion Technique

Outcome Measures

Primary Outcomes (1)

• evaluation of periodontal health by probing pocket depth, PPD

  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 Outcomes (2)

• valuation of periodontal health by plaque index, PI

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

• 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

Study Arms (2)

rapid palatal expansion (RPE) using the Haas appliance

slow palatal expansion (SPE)

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• palate narrow
• necessity of performing a expansion treatment

You may not qualify if:

• dental disease

Sponsors & Collaborators

• University of L'Aquila: lead

Study Sites (1)

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

L’Aquila, AQ, 67100, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Contract professor

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: June 28, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Last Updated: August 15, 2013

Record last verified: 2013-08

Locations

IT (1)