Health of PeriodontiumPhase 3NCT01314729
Comparison of the Effect of Two Types of Fixed Retainers on the Health of the Gums
A Phase 3 study testing Fiber-reinforced-composite retainer and Composite-wire retainer in people with Health of Periodontium, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
Different types of retainers have been used to assure the stability of orthodontic treatment. The aim of this study is clinical and radiographic comparison and evaluation of two common types of lingual fixed retainers on the health of periodontium. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Health of Periodontium
- What is being tested?
- Fiber-reinforced-composite retainer and Composite-wire retainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIran
- Study dates
- May 2010to May 2011
- Phase
- Phase 3
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The patient who have completed orthodontic treatment
- The patients should be healthy with no systemic disease at the time
- In clinical examination no apparent periodontal disease or inflammation should be present
- Patients who have complete permanent dentition (3rd molar eruption is not required)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shiraz Dental School
Shiraz, Fars, 7195615878
Sepideh Torkan, resident, 0098913 3271281, sepideh.torkan@yahoo.com
Morteza Oshagh, Associate professor
About this study
Official title: Clinical and Radiographic Comparison and Evaluation of Two Types of Lingual Fixed Retainers on the Health of Periodontium
Different types of retainers have been used to assure the stability of orthodontic treatment. The aim of this study is clinical and radiographic comparison and evaluation of two common types of lingual fixed retainers on the health of periodontium.
The participants in this study will be examined both clinically and radiographically just after the completion of orthodontic treatment and after a 6-month-period.
The results of the study will be analyzed with Mann-whitney and independent t-test.
- Conditions
- Health of Periodontium
- Being tested
- Fiber-reinforced-composite retainer, Composite-wire retainer
- Keywords
- Orthodontic fixed retainer, fiber-reinforced-composite retainer, composite-wire retainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber-reinforced-composite retainerDevice
this type of retainer is placed on the lingual surface of teeth from canine to canine just before the completion of orthodontic treatment
Composite-wire retainerDevice
this type of retainer is placed on the lingual surface of teeth from canine to canine just before the completion of orthodontic treatment to prevent treatment relapse
| Study group | Role | What they receive |
|---|---|---|
| Fiber-reinforced-composite retainer | Active comparator | Not described Receives: Device: Fiber-reinforced-composite retainer |
| composite-wire retainer | Active comparator | Not described Receives: Device: Composite-wire retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring periodontal status through clinical examination
for each participant, the examination is carried out right after the completion of orthodontic treatment and after a 6-month-period
Measured: approximately 20 months
measuring PDL width in periapical radiographs
for each participant, the examination is carried out right after the completion of orthodontic treatment and after a 6-month-period
Measured: approximately 20 months
Secondary outcomes (4)
Assessing periodontial status with Gingival Index
A gingival Index score will be assigned to each patient upon completion of orthodontic treatment and after a 6-month-period
Measured: approximately 20 months
assessing periodontal status using Plaque Index
A plaque Index score will be assigned to each patient upon completion of orthodontic treatment and after a 6-month-period
Measured: approximately 20 months
assessing periodontal status using Calculus Index
A Calculus Index score will be assigned to each patient upon completion of orthodontic treatment and after a 6-month-period
Measured: approximately 20 months
assessing periodontal status using Bleeding on probing
Each patient will be examined for bleeding on probing upon completion of orthodontic treatment and after a 6-month-period
Measured: approximately 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMay 2010
- Primary completionJan 2011
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health of PeriodontiumStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shiraz Dental School, Orthodontic Research Center
- Investigators
- Morteza Oshagh, Associate professor, Principal investigator, Shiraz Dental SchoolSepideh Torkan, resident, Principal investigator, Shiraz Dental School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314729
- Sponsor's protocol ID
- 8901372055shirazUMS
- Status last verified
- Feb 2011
- First submitted
- 7 Mar 2011
- Last updated
- 15 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Torkan S, Oshagh M, Khojastepour L, Shahidi S, Heidari S. Clinical and radiographic comparison of the effects of two types of fixed retainers on periodontium - a randomized clinical trial. Prog Orthod. 2014 Aug 27;15(1):47. doi: 10.1186/s40510-014-0047-8.
PubMed 25162332
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Comparison and Evaluation of Two Types of Lingual Fixed Retainers on the Health of Periodontium
- ClinicalTrials.gov ID
- NCT01314729
- Acronym / sponsor ID
- 8901372055shirazUMS
- Conditions
- Health of Periodontium
- Keywords
- Orthodontic fixed retainer, fiber-reinforced-composite retainer, composite-wire retainer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Collaborators
- Shiraz Dental School, Orthodontic Research Center
- Study start
- May 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- May 2011 (estimated)
- First posted
- 14 Mar 2011 (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.
Different types of retainers have been used to assure the stability of orthodontic treatment. The aim of this study is clinical and radiographic comparison and evaluation of two common types of lingual fixed retainers on the health of periodontium.
The participants in this study will be examined both clinically and radiographically just after the completion of orthodontic treatment and after a 6-month-period.
The results of the study will be analyzed with Mann-whitney and independent t-test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiber-reinforced-composite retainer | Active comparator | Device: Fiber-reinforced-composite retainer |
| composite-wire retainer | Active comparator | Device: Composite-wire retainer |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- The patient who have completed orthodontic treatment
- The patients should be healthy with no systemic disease at the time
- In clinical examination no apparent periodontal disease or inflammation should be present
- Patients who have complete permanent dentition (3rd molar eruption is not required)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiber-reinforced-composite retainerthis type of retainer is placed on the lingual surface of teeth from canine to canine just before the completion of orthodontic treatment | Device | Fiber-reinforced-composite retainer |
| Composite-wire retainerthis type of retainer is placed on the lingual surface of teeth from canine to canine just before the completion of orthodontic treatment to prevent treatment relapse | Device | composite-wire retainer |
Primary outcome
Measuring periodontal status through clinical examination
Time frame: approximately 20 months
for each participant, the examination is carried out right after the completion of orthodontic treatment and after a 6-month-period
measuring PDL width in periapical radiographs
Time frame: approximately 20 months
for each participant, the examination is carried out right after the completion of orthodontic treatment and after a 6-month-period
4 secondary outcomes
Assessing periodontial status with Gingival Index
Time frame: approximately 20 months
assessing periodontal status using Plaque Index
Time frame: approximately 20 months
assessing periodontal status using Calculus Index
Time frame: approximately 20 months
assessing periodontal status using Bleeding on probing
Time frame: approximately 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2011.
- Derived from this study: PubMed 25162332Torkan S, Oshagh M, Khojastepour L, Shahidi S, Heidari S. Clinical and radiographic comparison of the effects of two types of fixed retainers on periodontium - a randomized clinical trial. Prog Orthod. 2014 Aug 27;15(1):47. doi: 10.1186/s40510-014-0047-8.
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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.
Morteza Oshagh, Associate professor principal investigator
Shiraz Dental School
Sepideh Torkan, resident principal investigator
Shiraz Dental School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fiber-reinforced-composite retainer and Composite-wire retainer in people with Health of Periodontium, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 4 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 15 Mar 2011. 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 Iran. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sepideh Torkan, resident (0098 913327 1281, sepideh.torkan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring periodontal status through clinical examination (time frame: approximately 20 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01314729, which also lists 1 linked publication.
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 Mar 2011.