The Effect of Full Versus Partial Coverage Thermoformed Retainers in Dual Retention With a Lower Bonded Retainer, on Periodontal, Orthodontic, and Patient-Reported Outcomes

Официальное название

The Effect of Full Versus Partial Coverage Thermoformed Retainers in Dual Retention With a Lower Bonded Retainer, on Periodontal, Orthodontic, and Patient-Reported Outcomes: A Randomised Controlled Trial

Обзор

After braces are removed, teeth may move back toward their original positions. Retainers are used to help keep teeth straight after orthodontic treatment. This study compares two types of clear removable retainers used together with a fixed wire retainer behind the lower front teeth. One retainer covers the entire inner surface of the teeth (full coverage), while the other covers only part of the inner surface (partial coverage). The purpose of this study is to find out whether the two retainer designs differ in their effects on gum health, comfort, retainer breakages, stability of the orthodontic correction, comfort, and compliance. The findings from this study may help orthodontists choose the most suitable retainer design for future patients. Participants in this study will receive a fixed wire retainer on the lower front teeth and upper and lower clear removable retainers. They will be randomly assigned to receive either the full coverage or partial coverage lower retainer. Participants will attend follow-up visits at 1 month, 3 months, and 6 months after starting retainer wear. At these visits, the orthodontist will examine the teeth, gums, and retainers, and participants will complete a short questionnaire about their experience wearing the retainer. This study excluded participants who are pregnant or breastfeeding within the first 6 months, have uncontrolled medical conditions or gum disease, smoke or vape, require a Hawley retainer instead of a clear retainer, or have missing front teeth or certain jaw conditions. Participants may benefit from receiving retainers, oral hygiene care, and regular monitoring of their teeth and gum health at no additional cost. Participants will also receive an oral care kit during the debond appointment and at the 3-month and 6-month review visits. Possible risks include breakage of the retainers, which may require repair or replacement, gum problems if oral hygiene is not maintained, and slight tooth movement despite retainer use. If gum problems develop, appropriate cleaning and referral for further treatment may be provided. Replacement retainers required during the study period will be provided free of charge.

Подробное описание

Vivera retainers will be the only thermoformed retainers used throughout this study.

Вмешательства

• Устройство Partial coverage vivera retainer
  A removable lower retainer (Vivera retainer) with partial coverage design which covers part of the inside surface of lower teeth excluding the fixed bonded retainer
• Устройство Full coverage Vivera retainer
  A removable lower retainer (Vivera retainer) with full coverage design which covers the entire inside surface of lower teeth including the fixed bonded retainer

Первичные конечные точки

• Full mouth plaque score [Срок оценки: baseline, 1 month, 3 months and 6 months]
• Full mouth bleeding on probing score [Срок оценки: Baseline, 1 month, 3 months and 6 months]
• Periodontal probing depth of lower anterior teeth [Срок оценки: baseline, 1 month, 3 months and 6 months]
• Gingival recession on lower anterior teeth [Срок оценки: Baseline, 1 month, 3 months and 6 months]
• Integrity of clear retainer [Срок оценки: 3 months and 6 months]
• Breakages of fixed bonded retainers [Срок оценки: 1 month, 3 months, 6 months]

Вторичные конечные точки (3)

• Stability of lower anterior teeth [Срок оценки: Baseline, 3 months, 6 months]
• Quality of Life in Patients Wearing Orthodontic Retainers [Срок оценки: 3 months and 6 months]
• Patient's compliance [Срок оценки: 3 months and 6 months]

Критерии участия

Критерии включения

• Aged over 18 years.
• Controlled systemic diseases and conditions.
• Probing pocket depth ≤ 3 mm
• Bleeding on probing < 10 per cent
• Full mouth plaque scores of less than 20 per cent
• Just completed active orthodontic treatment involving lower arch
• Patient consent to dual retention in the lower arch

Критерии исключения

• Require a Hawley retainer in the lower arch.
• Patients in retention phase requiring replacement of retainers
• Uncontrolled systemic disease, including chronic or metabolic diseases.
• Pregnant or lactating mothers within six months postpartum.
• Taking medications that affect gingival health and architecture.
• Have one or more missing anterior teeth.
• Have congenital craniofacial deformities and syndromes, including cleft lip and/ or palate
• Cigarette or vape smokers

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Малайзия · 1 центр

• Faculty of Dentistry, Universiti Malaya — Kuala Lumpur

Идентификаторы

NCT: NCT07669129 · DF CD2609/0046 (P)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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