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

Palatal Expansion Technique Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01888666
• Other study ID #: Tecc01/2013
• Status: Completed
• Phase: N/A
• First received: February 4, 2013
• Last updated: August 14, 2013
• Start date: January 2013

Study information

• Verified date: August 2013
• Source: University of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

• palate narrow

• necessity of performing a expansion treatment

Exclusion Criteria:

• dental disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Palatal Expansion Technique

Locations

Country	Name	City	State
Italy	Dept. of Life, Health and Environmental Science, University of L'Aquila	L'Aquila	AQ

Sponsors (1)

Lead Sponsor	Collaborator
University of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	valuation of periodontal health by plaque index, PI	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	No
Secondary	evaluation of periodontal health by papillary bleeding index, PBI	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	No