RelapseNCT03881813
Effectiveness of Two Types of Fixed Lingual Retainers in Preventing Mandibular Incisor Relapse
A study testing Orthodontic retainers in people with Relapse, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The study evaluates effectiveness of two types of fixed retainers in post orthodontic patients. Half of the subjects are randomly allocated Group 1 retainer (FRC) and other half is given Group 2 retainer (MSW) and followed for a period of one year. Read more about this study
- Who is it for?
- Ages 14 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapse
- What is being tested?
- Orthodontic retainers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Nov 2017to 15 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects who have completed fixed appliance orthodontic treatment.
- Subjects who have signed the consent forms.
- Subjects who have accepted the terms and conditions of visiting after every three months for one year.
- Non extraction cases in the mandibular arch with no IPR.
- Patients without caries/ restoration/ fracture on the lower anterior teeth.
- Patients with healthy periodontium with no periodontal disease at that time.
Who cannot join
- Presence of syndrome or systemic disease.
- Patients taking medications/ drugs.
- Patients with poor oral hygiene.
- Patients with congenitally absent/ missing anterior teeth in the mandibular arch.
- Patients with habit of clenching/ bruxism.
- Patients with history of betel nut chewing.
- Presence of occlusal interferences.
Trial locations and contacts
1 site in 1 country.
About this study
The study evaluates effectiveness of two types of fixed retainers in post orthodontic patients. Half of the subjects are randomly allocated Group 1 retainer (FRC) and other half is given Group 2 retainer (MSW) and followed for a period of one year.
Read the detailed description
54 subjects were recruited and divided into two groups by random allocation. Consents were obtained . Group 1 received fiber reinforced composite retainer and group 2 received multistranded stainless steel wire retainer. The patients were recalled at every three months interval for a period of 12 months. They were evaluated for number of fractures, failure pattern based on adhesive remnant index and relapse tendency by measuring little's irregularity index.
- Conditions
- Relapse
- Being tested
- Orthodontic retainers
- Keywords
- fixed retainers, alignment
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic retainersDevice
Orthodontic retainers were bonded on the lower teeth of the subjects after fixed orthodontic treatment and were evaluated for their effectiveness for the followup of one year.
| Study group | Role | What they receive |
|---|---|---|
| Fiber reinforced composite retainers | Experimental | Fiber reinforced composite retainers were inserted in group 1 and were evaluated after every 3 months for a follow up period of 3 months. Receives: Device: Orthodontic retainers |
| Multistranded stainless steel retainers | Experimental | Multistranded stainless steel retainers were inserted in group 2 and were evaluated after every 3 months for a follow up period of 3 months. Receives: Device: Orthodontic retainers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse tendency
It was measured using Little's irregularity index
Measured: 12 months
Secondary outcomes (2)
Bond failure
Number of bond failure was assessed at each visit.
Measured: 12 months
Failure Pattern
Type of failure pattern was assessed based on Adhesive remnant index.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start12 Nov 2017
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RelapseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasreen Iqbal Nagani, Dow University of Health Sciences
- Investigators
- Nasreen Nagani, BDS, Principal investigator, DUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881813
- Sponsor's protocol ID
- DUHS/DR-0/2017/327
- Status last verified
- Mar 2019
- First submitted
- 17 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagani NI, Ahmed I, Tanveer F, Khursheed HM, Farooqui WA. "Clinical comparison of bond failure rate between two types of mandibular canine-canine bonded orthodontic retainers- a randomized clinical trial". BMC Oral Health. 2020 Jun 29;20(1):180. doi: 10.1186/s12903-020-01167-7.
PubMed 32600325
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Types of Fixed Lingual Retainers in Preventing Mandibular Incisor Relapse
- ClinicalTrials.gov ID
- NCT03881813
- Acronym / sponsor ID
- DUHS/DR-0/2017/327
- Conditions
- Relapse
- Keywords
- fixed retainers, alignment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 12 Nov 2017 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 20 Mar 2019 (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.
The study evaluates effectiveness of two types of fixed retainers in post orthodontic patients. Half of the subjects are randomly allocated Group 1 retainer (FRC) and other half is given Group 2 retainer (MSW) and followed for a period of one year.
Detailed description
54 subjects were recruited and divided into two groups by random allocation. Consents were obtained . Group 1 received fiber reinforced composite retainer and group 2 received multistranded stainless steel wire retainer. The patients were recalled at every three months interval for a period of 12 months. They were evaluated for number of fractures, failure pattern based on adhesive remnant index and relapse tendency by measuring little's irregularity index.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiber reinforced composite retainers | Experimental | Device: Orthodontic retainersFiber reinforced composite retainers were inserted in group 1 and were evaluated after every 3 months for a follow up period of 3 months. |
| Multistranded stainless steel retainers | Experimental | Device: Orthodontic retainersMultistranded stainless steel retainers were inserted in group 2 and were evaluated after every 3 months for a follow up period of 3 months. |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Subjects who have completed fixed appliance orthodontic treatment.
- Subjects who have signed the consent forms.
- Subjects who have accepted the terms and conditions of visiting after every three months for one year.
- Non extraction cases in the mandibular arch with no IPR.
- Patients without caries/ restoration/ fracture on the lower anterior teeth.
Key exclusion criteria (7 listed)
- Presence of syndrome or systemic disease.
- Patients taking medications/ drugs.
- Patients with poor oral hygiene.
- Patients with congenitally absent/ missing anterior teeth in the mandibular arch.
- Patients with habit of clenching/ bruxism.
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 |
|---|---|---|
| Orthodontic retainersOrthodontic retainers were bonded on the lower teeth of the subjects after fixed orthodontic treatment and were evaluated for their effectiveness for the followup of one year. | Device | Fiber reinforced composite retainers, Multistranded stainless steel retainers |
Primary outcome
Relapse tendency
Time frame: 12 months
It was measured using Little's irregularity index
2 secondary outcomes
Bond failure
Time frame: 12 months
Failure Pattern
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Derived from this study: PubMed 32600325Nagani NI, Ahmed I, Tanveer F, Khursheed HM, Farooqui WA. "Clinical comparison of bond failure rate between two types of mandibular canine-canine bonded orthodontic retainers- a randomized clinical trial". BMC Oral Health. 2020 Jun 29;20(1):180. doi: 10.1186/s12903-020-01167-7.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nasreen Nagani, BDS principal investigator
DUHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic retainers in people with Relapse, run by Dow University of Health Sciences at 1 site in Pakistan.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 21 Mar 2019. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse tendency (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03881813, which also lists 1 linked publication.
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 21 Mar 2019.