Orthodontic Appliance Complication Clinical Trial
Official title:
Periodontal and Orthodontic Outcomes of Straight Versus Looped Fixed Retainers: a Split-mouth Randomized Controlled Trial
The goal of this split-mouth, head-to-head, randomized controlled trial is to compare the effects of a fixed straight retainer with the V- loop bonded retainer on periodontal health in patients with the requirement of continuous fixed retention for 12-24 months after orthodontic treatment. The main question it aims to answer is whether the V- loop bonded retainer is more effective than fixed straight retainer for periodontal health management. Each patient will receive 2 lower fixed and bonded retainers: (1) a straight wire retainer (SWR) and (2) a looped wire retainer (LWR). Patients will be asked to floss once daily with a thread flosser. Researchers will compare the effects of two types of retainers to see if there is a statistically significant difference.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | October 31, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 40 Years |
Eligibility | Inclusion Criteria: - Patients in need of continuous fixed retention for 12-24 months after orthodontic treatment - Good periodontal health (i.e., no clinical attachment loss and < 10% bleeding on probing) Exclusion Criteria: - History of oral prophylaxis in the past 6 months - History of any systemic illness such as diabetes - Preexisting or post-orthodontic periodontal disease - Current intake of antibiotic and/or anti-inflammatory medications - Smoking - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King Abdulaziz University, Department of Periodontics | Jeddah |
Lead Sponsor | Collaborator |
---|---|
King Abdulaziz University |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of retainer failures and teeth stability through clinical examination | The examination will be carried out for each participant to assess the final outcome of bonds of assigned intervention immediately following the orthodontic treatment and after intervals of six months and two years. | Approximately 2 years | |
Primary | Measurement of the Little's Irregularity Index to assess the crowding of Mandibular anterior arch | The examination will be carried out for each participant to assess the final outcome assigned interventions immediately following the orthodontic treatment and after intervals of six months and two years.
The scale of the index includes the following: 0: Perfect Alignment 1-3: Minimal Irregularity 4-6: Moderate Irregularity 7-9: Severe Irregularity 10: Very Severe Irregularity The value represents the total horizontal displacement of the anatomical contact points of the mandibular anterior teeth in millimeters. |
Approximately 2 years | |
Secondary | Change from Baseline (immediately following the orthodontic treatment) in gingivitis on the 4-point Modified Gingival Index (MGI) at the short-term (6 months) and long-term (2 years) | The MGI is a non-invasive visual instrument designed to evaluate the progression of gingivitis. The scale ranges from 0 (normal gingiva) to 3. (severe inflammation with tendency to spontaneous bleeding). Change = (Year 2 Score - Baseline Score) | Approximately 2 years | |
Secondary | Change from Baseline (immediately following the orthodontic treatment) in plaque accumulation on O'leary Plaque Index (PI) at the short-term (6 months) and long-term (2 years) | The PI is a valid and reliable assessment tool that records the presence of mineralized deposits and soft debris on all 4 surfaces of every tooth. It utilizes a rating scale from 0 (no plaque) to 1 (plaque present at gingival margin). Change = (Year 2 Score - Baseline Score) | Approximately 2 years | |
Secondary | Change from Baseline (immediately following the orthodontic treatment) in gingival bleeding on the Gingival Bleeding Index (GBI) by Ainamo and Bay at the short-term (6 months) and long-term (2 years) | The GBI is a reliable measure of periodontal stability. It uses delicate probing of the gingival sulcus orifice. Using a standardized periodontal probe with a 0.6 mm tip and 1 mm marking, the bleeding on probing (BOP) will be evaluated. A skilled examiner will measure BOP using probes with 0.25 N or less of force (25 g). If bleeding starts within 10 seconds, a positive finding is recorded. | Approximately 2 years | |
Secondary | Change from Baseline (immediately following the orthodontic treatment) in oral hygiene questionnaire at the short-term (6 months) and long-term (2 years) | Participants will be adminstered a self-reported oral hygiene questionnaire on brushing and flossing frequency, patient satisfaction with the retainers, and ease of flossing to determine their overall satisfaction with the interventions. | Approximately 2 years |
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