Periodontal and Orthodontic Outcomes of Straight vs. Looped Fixed Retainers

NCT05644119 | Unknown

• 1 other identifier: 084-09-22
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthodontic Appliance Complication; Orthodontic Appliance Design; Orthodontic Treatment

Keywords

Orthodontic retention; Fixed orthodontic retention; Fixed orthodontic retainer; V- loop bonded retainer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

  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)

  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)

  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)

  Approximately 2 years

Study Arms (2)

V-looped Wire Retainer (LWR)

EXPERIMENTAL

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

Straight Wire Retainer (SWR)

ACTIVE COMPARATOR

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

Interventions

V- loop Bonded Orthodontic Retainer DEVICE

The V- loop bonded retainer is a unique design that not just provides tooth stability but also allows flossing with ease.

Also known as: V-loop Bonded Lingual Retainer, Wave Orthodontic Retainer

V-looped Wire Retainer (LWR)

Straight Wire Retainer DEVICE

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.

Straight Wire Retainer (SWR)

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University, Department of Periodontics

Jeddah, 80209, Saudi Arabia

RECRUITING

Study Officials

• Talal Zahid, M.S

  Associate Professor, King Abdulaziz University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Talal Zahid, M.S

CONTACT

00966554667998; tzahid@kau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor | Chairman, Department of Periodontics

Model Details: Split-mouth Design

Study Record Dates

• First Submitted: November 19, 2022
• First Posted: December 9, 2022
• Study Start: November 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: October 31, 2023
• Last Updated: December 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)