Orthodontic RetentionNCT07669129
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 study testing Partial coverage vivera retainer and Full coverage Vivera retainer in people with Orthodontic Retention, run by University of Malaya at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Retention
- What is being tested?
- Partial coverage vivera retainer and Full coverage Vivera retainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jul 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Faculty of Dentistry, Universiti Malaya
Kuala Lumpur, Kuala Lumpur, 50603
About this study
Official title: 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.
Read more
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.
Read the detailed description
Vivera retainers will be the only thermoformed retainers used throughout this study.
- Conditions
- Orthodontic Retention
- Being tested
- Partial coverage vivera retainer, Full coverage Vivera retainer
- Keywords
- Orthodontic retention, clear retainer, fixed bonded retainer, periodontal health, breakage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial coverage vivera retainerDevice
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
Full coverage Vivera retainerDevice
A removable lower retainer (Vivera retainer) with full coverage design which covers the entire inside surface of lower teeth including the fixed bonded retainer
| Study group | Role | What they receive |
|---|---|---|
| Full coverage clear retainer | Active comparator | A removable lower retainer covers the entire inside surface of lower teeth including the fixed bonded retainer Receives: Device: Full coverage Vivera retainer |
| Partial coverage clear retainer | Active comparator | A removable lower retainer covers part of inside surface of lower teeth excluding the fixed bonded retainer Receives: Device: Partial coverage vivera retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full mouth plaque score
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)
Measured: baseline, 1 month, 3 months and 6 months
Full mouth bleeding on probing score
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)
Measured: Baseline, 1 month, 3 months and 6 months
Periodontal probing depth of lower anterior teeth
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)
Measured: baseline, 1 month, 3 months and 6 months
Gingival recession on lower anterior teeth
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)
Measured: Baseline, 1 month, 3 months and 6 months
Integrity of clear retainer
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
Measured: 3 months and 6 months
Breakages of fixed bonded retainers
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.
Measured: 1 month, 3 months, 6 months
Secondary outcomes (3)
Stability of lower anterior teeth
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)
Measured: Baseline, 3 months, 6 months
Quality of Life in Patients Wearing Orthodontic Retainers
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.
Measured: 3 months and 6 months
Patient's compliance
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.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669129
- Sponsor's protocol ID
- DF CD2609/0046 (P)
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07669129
- Acronym / sponsor ID
- DF CD2609/0046 (P)
- Conditions
- Orthodontic Retention
- Keywords
- Orthodontic retention, clear retainer, fixed bonded retainer, periodontal health, breakage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Vivera retainers will be the only thermoformed retainers used throughout this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full coverage clear retainer | Active comparator | Device: Full coverage Vivera retainerA removable lower retainer covers the entire inside surface of lower teeth including the fixed bonded retainer |
| Partial coverage clear retainer | Active comparator | Device: Partial coverage vivera retainerA removable lower retainer covers part of inside surface of lower teeth excluding the fixed bonded retainer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial coverage vivera retainerA removable lower retainer (Vivera retainer) with partial coverage design which covers part of the inside surface of lower teeth excluding the fixed bonded retainer | Device | Partial coverage clear retainer |
| Full coverage Vivera retainerA removable lower retainer (Vivera retainer) with full coverage design which covers the entire inside surface of lower teeth including the fixed bonded retainer | Device | Full coverage clear retainer |
Primary outcome
Full mouth plaque score
Time frame: 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)
Full mouth bleeding on probing score
Time frame: 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)
Periodontal probing depth of lower anterior teeth
Time frame: 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)
Gingival recession on lower anterior teeth
Time frame: 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)
Integrity of clear retainer
Time frame: 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
Breakages of fixed bonded retainers
Time frame: 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.
3 secondary outcomes
Stability of lower anterior teeth
Time frame: Baseline, 3 months, 6 months
Quality of Life in Patients Wearing Orthodontic Retainers
Time frame: 3 months and 6 months
Patient's compliance
Time frame: 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Active, not recruitingObservational study
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Digital vs Conventional VFR in Post-Orthodontic Retention
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Retention With Three Different Bonded Retainers a Multicenter, Randomized Controlled Trial With 5-year Follow-up
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3D-Printed vs Conventional Fixed Retainers After Orthodontic Treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial coverage vivera retainer and Full coverage Vivera retainer in people with Orthodontic Retention, run by University of Malaya at 1 site in Malaysia.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 23 Jul 2026. 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 Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZHI MEI CHIA (+60143438922, s2102418@siswa.um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full mouth plaque score (time frame: baseline, 1 month, 3 months and 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2026.