Periodontal and Orthodontic Outcomes of Straight vs. Looped Fixed Retainers

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.

Study Overview

• Status: Recruiting
• Conditions: Orthodontic Appliance Complication; Orthodontic Appliance Design; Orthodontic Treatment
• Intervention / Treatment: Device: V- loop Bonded Orthodontic Retainer; Device: Straight Wire Retainer

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Talal Zahid, M.S; Phone Number: 00966554667998; Email: tzahid@kau.edu.sa

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia, 80209
    • Recruiting
    • King Abdulaziz University, Department of Periodontics
    • Contact: Talal Zahid, M.S; Phone Number: 00966554667998; Email: tzahid@kau.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V-looped Wire Retainer (LWR); The LWR is a 0.569-mm (0.022-inch) Blue Elgiloy (soft) round wire (RMO). The retainer will extend from the left canine to the right central incisor.	Device: V- loop Bonded Orthodontic Retainer; The V- loop bonded retainer is a unique design that not just provides tooth stability but also allows flossing with ease.; Other Names: V-loop Bonded Lingual Retainer; Wave Orthodontic Retainer
Active Comparator: Straight Wire Retainer (SWR); The SWR is 0.8-mm twisted stainless steel wire (3M Unitek, Monrovia, Calif). The retainer will extend from the right canine to the left central incisor.	Device: Straight Wire Retainer; The straight wire retainer is a fixed bonded orthodontic retainer. This involves attaching a metal wire to the back of the teeth to keep it in position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: King Abdulaziz University
• Investigators: Principal Investigator: Talal Zahid, M.S, Associate Professor, King Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: November 19, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Estimate): December 9, 2022

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Orthodontic retention; Fixed orthodontic retention; Fixed orthodontic retainer; V- loop bonded retainer
• Other Study ID Numbers: 084-09-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No