Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

21. Juni 2026 aktualisiert von: University of Malaya

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Geschätzt)

42

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
        • Faculty of Dentistry, Universiti Malaya

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Full coverage clear retainer
A removable lower retainer covers the entire inside surface of lower teeth including the fixed bonded retainer
Gerät: 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
Aktiver Komparator: Partial coverage clear retainer
A removable lower retainer covers part of inside surface of lower teeth excluding the fixed bonded retainer
Gerät: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Full mouth plaque score
Zeitfenster: baseline, 1 month, 3 months and 6 months

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
Full mouth bleeding on probing score
Zeitfenster: Baseline, 1 month, 3 months and 6 months

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
Periodontal probing depth of lower anterior teeth
Zeitfenster: baseline, 1 month, 3 months and 6 months

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
Gingival recession on lower anterior teeth
Zeitfenster: Baseline, 1 month, 3 months and 6 months

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
Integrity of clear retainer
Zeitfenster: 3 months and 6 months
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
3 months and 6 months
Breakages of fixed bonded retainers
Zeitfenster: 1 month, 3 months, 6 months
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.
1 month, 3 months, 6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Stability of lower anterior teeth
Zeitfenster: Baseline, 3 months, 6 months

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
Quality of Life in Patients Wearing Orthodontic Retainers
Zeitfenster: 3 months and 6 months
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.
3 months and 6 months
Patient's compliance
Zeitfenster: 3 months and 6 months
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.
3 months and 6 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Malaya

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

30. Juni 2027

Studienabschluss (Geschätzt)

30. September 2027

Studienanmeldedaten

Zuerst eingereicht

12. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Juni 2026

Zuerst gepostet (Tatsächlich)

25. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • DF CD2609/0046 (P)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Kieferorthopädische Retention

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Portugal

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

3
Abonnieren