The Effect of Full Versus Partial Coverage Thermoformed Retainers in Dual Retention With a Lower Bonded Retainer, on Periodontal, Orthodontic, and Patient-Reported Outcomes
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
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: ZHI MEI CHIA
- Numer telefonu: +60143438922
- E-mail: s2102418@siswa.um.edu.my
Lokalizacje studiów
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malezja, 50603
- Faculty of Dentistry, Universiti Malaya
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: Full coverage clear retainer
A removable lower retainer covers the entire inside surface of lower teeth including the fixed bonded retainer
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A removable lower retainer (Vivera retainer) with full coverage design which covers the entire inside surface of lower teeth including the fixed bonded retainer
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Aktywny komparator: Partial coverage clear retainer
A removable lower retainer covers part of inside surface of lower teeth excluding the fixed bonded retainer
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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
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Full mouth plaque score
Ramy czasowe: baseline, 1 month, 3 months and 6 months
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To evaluate full mouth plaque score associated with clear retainers with partial or full coverage designs when used in conjunction with fixed bonded retainers in the lower arch. Scale title: Full mouth plaque score Minimum value: 0% Maximum value: 100% Higher score means indicate worse plaque accumulation and poorer oral hygiene. (worse outcome) |
baseline, 1 month, 3 months and 6 months
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Full mouth bleeding on probing score
Ramy czasowe: Baseline, 1 month, 3 months and 6 months
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To evaluate full mouth bleeding on probing score associated with clear retainers with partial or full coverage designs when used in conjunction with fixed bonded retainers in the lower arch. Scale title: Full mouth bleeding on probing score Minimum value: 0% Maximum value: 100% Higher score means indicate worse periodontal health (worse outcome) |
Baseline, 1 month, 3 months and 6 months
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Periodontal probing depth of lower anterior teeth
Ramy czasowe: baseline, 1 month, 3 months and 6 months
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To evaluate periodontal probing depth of lower anterior teeth associated with clear retainers with partial or full coverage designs when used in conjunction with fixed bonded retainers in the lower arch Scale title: Periodontal probing depth Minimum value: 0mm Maximum value: No fixed upper limit Higher score means indicate worse periodontal health (worse outcome) |
baseline, 1 month, 3 months and 6 months
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Gingival recession on lower anterior teeth
Ramy czasowe: Baseline, 1 month, 3 months and 6 months
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To evaluate gingival recession on lower anterior teeth associated with clear retainers with partial or full coverage designs when used in conjunction with fixed bonded retainers in the lower arch Scale title: Gingival recession Minimum value: 0mm Maximum value: No fixed upper limit Higher score means indicate worse periodontal health (worse outcome) |
Baseline, 1 month, 3 months and 6 months
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Integrity of clear retainer
Ramy czasowe: 3 months and 6 months
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To evaluate the incidence of clear retainer breakages associated with partial or full coverage designs when used in combination with fixed bonded retainers in the lower arch
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3 months and 6 months
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Breakages of fixed bonded retainers
Ramy czasowe: 1 month, 3 months, 6 months
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To evaluate the incidence of breakages involving bonded wire or adhesive resin of fixed bonded retainers when used in combination with clear retainers in either partial or full coverage designs in the lower arch.
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1 month, 3 months, 6 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Stability of lower anterior teeth
Ramy czasowe: Baseline, 3 months, 6 months
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To evaluate the stability of lower anterior teeth (using Little's Irregularity Index) associated with partial and full coverage designs of clear retainers when used in conjunction with fixed bonded retainers. Scale title: Little's Irregularity Index Minimum value: 0mm Maximum value: No fixed upper limit Higher scores indicate greater relapse and worse alignment. (worse outcome) |
Baseline, 3 months, 6 months
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Quality of Life in Patients Wearing Orthodontic Retainers
Ramy czasowe: 3 months and 6 months
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To evaluate the patient's quality of life associated with partial or full coverage designs of clear retainers when used in conjunction with fixed bonded retainers.
Quality of life assessed using the Quality of Life in Patients Wearing Orthodontic Retainers questionnaire.
Total scores range from 0 score to 56 score, with higher scores indicating poorer quality of life related to retainer wear.
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3 months and 6 months
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Patient's compliance
Ramy czasowe: 3 months and 6 months
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Patient compliance associated with partial or full coverage clear retainers used in conjunction with fixed bonded retainers will be evaluated using Part B, Questions 1 and 2 of the Quality of Life in Patients Wearing Orthodontic Retainers questionnaire.
Compliance will be reported as "yes" or "no."
For non-compliance responses, reasons for non-compliance will also be recorded, with multiple responses permitted.
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3 months and 6 months
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- DF CD2609/0046 (P)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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