Palatal Expansion TechniqueNCT01888666
Comparison Between Rapid and Slow Palatal Expansion: Evaluation of Periodontal Indices
An observational study of Palatal Expansion Technique, run by University of L'Aquila at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Palatal Expansion Technique
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: patients attending the division of orthodontics of Department MeSVA, University of L'Aquila, Italy
Who may be able to join
- palate narrow
- necessity of performing a expansion treatment
Who cannot join
- dental disease
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dept. of Life, Health and Environmental Science, University of L'Aquila
L’Aquila, AQ, 67100
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| rapid palatal expansion (RPE) using the Haas appliance | Not described | |
| slow palatal expansion (SPE) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Change from Baseline in plaque index at 20 days and 5 months of active therapy
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.
Measured: Change from Baseline in papillary bleeding index at 20 days and 5 months of active therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palatal Expansion TechniqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Marchetti, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888666
- Sponsor's protocol ID
- Tecc01/2013
- Status last verified
- Aug 2013
- First submitted
- 4 Feb 2013
- Last updated
- 15 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Rapid and Slow Palatal Expansion: Evaluation of Periodontal Indices
- ClinicalTrials.gov ID
- NCT01888666
- Acronym / sponsor ID
- Tecc01/2013
- Conditions
- Palatal Expansion Technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rapid palatal expansion (RPE) using the Haas appliance | – | – |
| slow palatal expansion (SPE) | – | – |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients attending the division of orthodontics of Department MeSVA, University of L'Aquila, Italy
Key inclusion criteria (2 listed)
- palate narrow
- necessity of performing a expansion treatment
Key exclusion criteria (1 listed)
- dental disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
Related trials for Palatal Expansion Technique
Active, not recruiting
Teleorthodontics Versus Conventional Follow-up During Early Interceptive Orthodontic Treatment in Children
Teledentistry, Orthodontics, Interceptive
Recruiting
The Effectiveness of Early Intervention to Correct the Position of PDC:s
Ectopic Tooth Eruption, Palatal Expansion Technique
Not yet recruiting
Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea
OSA - Obstructive Sleep Apnea, Palatal Expansion Technique
Recruiting
3D Evaluation of Maxillary Expansion Methods
Maxillary Transverse Deficiency
Recruiting
Evaluation of Hard and Soft Tissue Change During Maxillary Expansion Using a Computer-aided Design / Computer-aided Manufacturing Appliance.
Palatal Expansion Technique
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palatal Expansion Technique, run by University of L'Aquila at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2013.