Clinical trial NCT05644119: Periodontal and Orthodontic Outcomes of Straight vs. Looped Fixed Retainers
Official title: Periodontal and Orthodontic Outcomes of Straight Versus Looped Fixed Retainers: a Split-mouth Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Appliance Complication
Orthodontic Appliance Design
Orthodontic Treatment
Keywords: Orthodontic retention
Fixed orthodontic retention
Fixed orthodontic retainer
V- loop bonded retainer
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth Design
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Ensuring alignment stability is a major challenge for orthodontists following an orthodontic treatment. This has led to the development of various orthodontic retention methods to enhance stability. Both fixed and removable retainers have been in use for years. However, most orthodontists nowadays prefer fixed bonded retainers over removable ones due to their many advantages, including easy to wear, being patient compliance free, long-term usability and stability, and better aesthetics. Over the past decades, many variations of fixed retainers have been developed. Of these, the current gold standard is the straight type flexible spiral (multistranded) wire retainer. Nevertheless, a major concern of using fixed straight retainers is the potential for periodontal health compromise. They are known to make oral hygiene maintenance more difficult for the patient, which in turn may lead to periodontal diseases due to more plaque and calculus accumulation. The wave or V- loop bonded retainer may be a solution to this problem, as it provides stability of teeth yet allows flossing with ease.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of retainer failures and teeth stability through clinical examination
timeFrame: Approximately 2 years
measure: Measurement of the Little's Irregularity Index to assess the crowding of Mandibular anterior arch
timeFrame: Approximately 2 years
Secondary outcomes:
measure: 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)
timeFrame: Approximately 2 years
measure: 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)
timeFrame: Approximately 2 years
measure: 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)
timeFrame: Approximately 2 years
measure: Change from Baseline (immediately following the orthodontic treatment) in oral hygiene questionnaire at the short-term (6 months) and long-term (2 years)
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University, Department of Periodontics
Study officials:
affiliation: Associate Professor, King Abdulaziz University
name: Talal Zahid, M.S
role: PRINCIPAL_INVESTIGATOR
References: