Comparison of the Effect of Two Types of Fixed Retainers on the Health of the Gums

Study Overview
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Brief Summary
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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.

Official Title
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Clinical and Radiographic Comparison and Evaluation of Two Types of Lingual Fixed Retainers on the Health of Periodontium

Conditions
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Health of Periodontium

Intervention / Treatment
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* Device: Fiber-reinforced-composite retainer
* Device: Composite-wire retainer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fiber-reinforced-composite retainer<br> | Device: Fiber-reinforced-composite retainer<br>* this type of retainer is placed on the lingual surface of teeth from canine to canine just before the completion of orthodontic treatment<br>|
| Active Comparator: composite-wire retainer<br> | Device: Composite-wire retainer<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | approximately 20 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | approximately 20 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthodontic fixed retainer, fiber-reinforced-composite retainer, composite-wire retainer