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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 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

42

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Full coverage clear retainer
A removable lower retainer covers the entire inside surface of lower teeth including the fixed bonded retainer
Enhed: 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
Aktiv komparator: Partial coverage clear retainer
A removable lower retainer covers part of inside surface of lower teeth excluding the fixed bonded retainer
Enhed: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Full mouth plaque score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stability of lower anterior teeth
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Malaya

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

30. juni 2027

Studieafslutning (Anslået)

30. september 2027

Datoer for studieregistrering

Først indsendt

12. maj 2026

Først indsendt, der opfyldte QC-kriterier

21. juni 2026

Først opslået (Faktiske)

25. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • DF CD2609/0046 (P)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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