Periodontal and Orthodontic Outcomes of Straight vs. Looped Fixed Retainers

NCT ID: NCT05644119

Last Updated: 2022-12-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-10-31

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.

Conditions

Orthodontic Appliance Complication; Orthodontic Appliance Design; Orthodontic Treatment

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

V- loop Bonded Orthodontic Retainer

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Straight Wire Retainer

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

V-loop Bonded Lingual Retainer; Wave Orthodontic Retainer

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Talal Zahid

Associate Professor | Chairman, Department of Periodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Talal Zahid, M.S

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, King Abdulaziz University

Locations

King Abdulaziz University, Department of Periodontics

Jeddah, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Talal Zahid, M.S

Role: CONTACT

Phone: 00966554667998

Email: tzahid@kau.edu.sa

Facility Contacts

Talal Zahid, M.S

Role: primary

Other Identifiers

084-09-22

Identifier Type: -

Identifier Source: org_study_id