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Orthodontic Appliance ComplicationNCT05644119

Periodontal and Orthodontic Outcomes of Straight vs. Looped Fixed Retainers

A study testing V- loop Bonded Orthodontic Retainer and Straight Wire Retainer in people with Orthodontic Appliance Complication and Orthodontic Appliance Design, run by King Abdulaziz University at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 40 yearsHealthy volunteers can take part
What is being tested?
V- loop Bonded Orthodontic Retainer and Straight Wire Retainer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSaudi Arabia
Study dates
1 Nov 2022to 31 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Talal Zahid, M.S contact

00966554667998

tzahid@kau.edu.sa

Saudi Arabia1 site, 1 recruiting

  • King Abdulaziz University, Department of Periodontics

    Jeddah, 80209

    Talal Zahid, M.S, 00966554667998, tzahid@kau.edu.sa

    Recruiting

Other trials in Saudi Arabia

About this study

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.

Read more

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.

Read the 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.

Being tested
V- loop Bonded Orthodontic Retainer, Straight Wire Retainer
Keywords
Orthodontic retention, Fixed orthodontic retention, Fixed orthodontic retainer, V- loop bonded retainer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • V- loop Bonded Orthodontic RetainerDevice

    Also called V-loop Bonded Lingual Retainer, Wave Orthodontic Retainer

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

  • Straight Wire RetainerDevice

    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.

Study groups in NCT05644119
Study groupRoleWhat they receive
V-looped Wire Retainer (LWR)ExperimentalThe 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.
Receives: Device: V- loop Bonded Orthodontic Retainer
Straight Wire Retainer (SWR)Active comparatorThe 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.
Receives: Device: Straight Wire Retainer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Approximately 2 years

  2. 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.

    Measured: Approximately 2 years

Secondary outcomes (4)

  1. 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)

    Measured: Approximately 2 years

  2. 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)

    Measured: Approximately 2 years

  3. 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.

    Measured: Approximately 2 years

  4. 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.

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2022
  2. Study start1 Nov 2022
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion31 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Split-mouth Design
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05644119
Sponsor's protocol ID
084-09-22
Status last verified
Nov 2022
First submitted
19 Nov 2022
Last updated
9 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing V- loop Bonded Orthodontic Retainer and Straight Wire Retainer in people with Orthodontic Appliance Complication and Orthodontic Appliance Design, run by King Abdulaziz University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Talal Zahid, M.S (00966554667998, tzahid@kau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of retainer failures and teeth stability through clinical examination (time frame: Approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05644119.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.

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