RelapseNCT05879588
: "Comparative Evaluation of 3 Dimensional Changes of Dentition in Post Orthodontic Patients With Immediate vs Delayed (Post 3 Days) Retainer Delivery
A study testing immediate orthodontic retainer delivery and delayed orthodontic retainer delivery in people with Relapse, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Maintaining teeth in their corrected position after orthodontic treatment is one of the most challenging part of orthodontic treatment and hence a period of stabilization termed as retention is provided after orthodontic treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapse
- What is being tested?
- immediate orthodontic retainer delivery and delayed orthodontic retainer delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 25 May 2022to 25 Apr 2024
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult orthodontic patients treated with 022*028 MBT appliance with following sequence of wires- 014, 016, 16*22, 17*25, 19*25 NiTi followed by 19*25 SS.
- Treatment duration of 24-36 months with Optimal functional occlusion at end of treatment (PAR score >70%).
- Class I bimax and Class II div I with pre-treatment Little's irregularity index <6mm in both upper and lower arch.
- Nonsurgical and non-orthopedic patients.
- Non syndromic patients and no impaction of teeth except third molars.
- No previous orthodontic treatment.
- Optimal periodontal condition and Good oral hygiene.
- Good compliance regarding retainer wear (Cases who never missed more than 2 consecutive appointment and who reported with less no of breakages).
Who cannot join
- Subjects with incomplete orthodontic treatment.
- TMJ disorder patients.
- Any systemic disease affecting bone and general growth.
- Patients with incomplete records.
- Patient who fail to follow up or undergo complete treatment.
- Patient with learning difficulties
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
Rekha Sharma, MDS, 7982391690 ext. +91, rajsringari@gmail.com
Dr Vibhore Sharma, BDS
About this study
Official title: Comparative Evaluation of 3 Dimensional Changes of Dentition in Post Orthodontic Patients With Immediate vs Delayed (Post 3 Days) Retainer Delivery-A Randomized Control Trial"
Maintaining teeth in their corrected position after orthodontic treatment is one of the most challenging part of orthodontic treatment and hence a period of stabilization termed as retention is provided after orthodontic treatment. Retention is one of the most important phase of orthodontic treatment that attempts to keep teeth in the corrected positions after treatment with orthodontic braces.
Following literature search there is no scientific evidence for the timing of retainer delivery.The present study is designed to know if post orthodontic tooth movement vary with different time of retainer delivery and since there is unusual delay after debonding as the retainer is fabricated at the laboratory. Such a study will help us to find out within which time period the retainer should be delivered
Read the detailed description
The proposed study will be a prospective, non-pharmacological, single blind, randomized clinical trial to evaluate if there is a difference in transverse (X axis), A-P(Y-axis) and Vertical plane(Z-axis) of dentition in two group of post orthodontic treatment patients with immediate retainer delivery in one group and post 3 days retainer delivery in other group of patients. The present study will be conducted in the Department of Orthodontic and Dentofacial Orthopedics, P.G.I.D.S, Pt. B.D Sharma University of health sciences, Rohtak. The study will be carried out after the institutional approval obtained from ethical committee.
A sample size of 18 patients was calculated keeping confidence interval 95% with power 80%. Accounting for a 10% drop out rate, 20 patients will be enrolled in each group. Patient will be randomly allocated to the study group by a person not involved in the trial using computer generated randomization list. Changes in the tooth movement in transverse(X-axis), A-P(Y-axis), Vertical plane(Z axis) will be compared in terms of intercanine width, intermolar width, overjet, overbite and contact point displacement between the two groups at following time intervals. These parameters will be charted at T0, T1, T2,T3 and T4 for each patient.Changes in the tooth movement in transverse(X-axis), A-P(Y-axis), Vertical plane(Z-axis) will be compared in terms of intercanine width, intermolar width, overjet, overbite and contact point displacement between the two groups at following time intervals. These parameters will be charted at T0, T1, T2,T3 and T4 for each patient. T0 - Baseline records, at the time of debonding. T1 - Records obtained at the time of retainer delivery. T2 - Records obtained after 1 month of retainer delivery. T3 - Records obtained after 3 months of retainer delivery. T4 - Records obtained after 6 months of retainer delivery
- Conditions
- Relapse
- Being tested
- immediate orthodontic retainer delivery, delayed orthodontic retainer delivery
- Keywords
- orthodontic retention
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate orthodontic retainer deliveryOther
post orthodontic treatment patients will be given orthodontic retainer immediately after debonding
delayed orthodontic retainer deliveryOther
post orthodontic treatment patients will be given orthodontic retainer after 3 days of debonding
| Study group | Role | What they receive |
|---|---|---|
| control group-immediate retainer delivery | Other | Retainer will be given to the patients immediately [Just after debonding]. Receives: Other: immediate orthodontic retainer delivery |
| experimental group-delayed retainer delivery | Active comparator | Retainer will be delivered to the patients 3 days post debonding. Receives: Other: delayed orthodontic retainer delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
overjet
sagittal distance between upper and lower incisors
Measured: T0-baseline on the day of debonding
overjet
sagittal distance between upper and lower incisors
Measured: T1- 3 days after debonding
overjet
sagittal distance between upper and lower incisors
Measured: T2- 1 month after debonding
overjet
sagittal distance between upper and lower incisors
Measured: T3- 3 months after debonding
overjet
sagittal distance between upper and lower incisors
Measured: T4- 6 months after debonding
contact point displacement
displacement of contact points in anterior teeth
Measured: T0-baseline on the day of debonding
contact point displacement
displacement of contact points in anterior teeth
Measured: T1- 3 days after debonding
contact point displacement
displacement of contact points in anterior teeth
Measured: T2- 1 month after debonding
contact point displacement
displacement of contact points in anterior teeth
Measured: T3- 3 months after debonding
contact point displacement
displacement of contact points in anterior teeth
Measured: T4- 6 months after debonding
Overbite
vertical overlap of upper and lower incisors
Measured: T0- Baseline on the day of debonding
Overbite
vertical overlap of upper and lower incisors
Measured: T1- 3 days after debonding
Overbite
vertical overlap of upper and lower incisors
Measured: T2- 1 month after debonding
Overbite
vertical overlap of upper and lower incisors
Measured: T3- 3 months after debonding
Overbite
vertical overlap of upper and lower incisors
Measured: T4- 6 months after debonding
Intermolar width
transverse distance between the first molars
Measured: T0-baseline on the day of debonding
Intermolar width
transverse distance between the first molars
Measured: T1- 3 days after debonding
Intermolar width
transverse distance between the first molars
Measured: T2- 1 month after debonding
Intermolar width
transverse distance between the first molars
Measured: T3- 3 months after debonding
Intermolar width
transverse distance between the first molars
Measured: T4- 6 months after debonding
Intercanine width
transverse distance between canine
Measured: T0-baseline on the day of debonding
Intercanine width
transverse distance between canine
Measured: T1- 3 days after debonding
Intercanine width
transverse distance between canine
Measured: T2- 1 month after debonding
Intercanine width
transverse distance between canine
Measured: T3- 3 months after debonding
Intercanine width
transverse distance between canine
Measured: T4- 6 months after debonding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start25 May 2022
- Primary completion25 Dec 2023 (estimated)
- Study completion25 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RelapseStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879588
- Sponsor's protocol ID
- PGIDS/BHRC/22/32
- Status last verified
- May 2023
- First submitted
- 27 Jul 2022
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- 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 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of 3 Dimensional Changes of Dentition in Post Orthodontic Patients With Immediate vs Delayed (Post 3 Days) Retainer Delivery-A Randomized Control Trial"
- ClinicalTrials.gov ID
- NCT05879588
- Acronym / sponsor ID
- PGIDS/BHRC/22/32
- Conditions
- Relapse
- Keywords
- orthodontic retention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 25 Dec 2023 (estimated)
- Study completion
- 25 Apr 2024 (estimated)
- First posted
- 30 May 2023 (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.
Maintaining teeth in their corrected position after orthodontic treatment is one of the most challenging part of orthodontic treatment and hence a period of stabilization termed as retention is provided after orthodontic treatment. Retention is one of the most important phase of orthodontic treatment that attempts to keep teeth in the corrected positions after treatment with orthodontic braces.
Following literature search there is no scientific evidence for the timing of retainer delivery.The present study is designed to know if post orthodontic tooth movement vary with different time of retainer delivery and since there is unusual delay after debonding as the retainer is fabricated at the laboratory. Such a study will help us to find out within which time period the retainer should be delivered
Detailed description
The proposed study will be a prospective, non-pharmacological, single blind, randomized clinical trial to evaluate if there is a difference in transverse (X axis), A-P(Y-axis) and Vertical plane(Z-axis) of dentition in two group of post orthodontic treatment patients with immediate retainer delivery in one group and post 3 days retainer delivery in other group of patients. The present study will be conducted in the Department of Orthodontic and Dentofacial Orthopedics, P.G.I.D.S, Pt. B.D Sharma University of health sciences, Rohtak. The study will be carried out after the institutional approval obtained from ethical committee.
A sample size of 18 patients was calculated keeping confidence interval 95% with power 80%. Accounting for a 10% drop out rate, 20 patients will be enrolled in each group. Patient will be randomly allocated to the study group by a person not involved in the trial using computer generated randomization list. Changes in the tooth movement in transverse(X-axis), A-P(Y-axis), Vertical plane(Z axis) will be compared in terms of intercanine width, intermolar width, overjet, overbite and contact point displacement between the two groups at following time intervals. These parameters will be charted at T0, T1, T2,T3 and T4 for each patient.Changes in the tooth movement in transverse(X-axis), A-P(Y-axis), Vertical plane(Z-axis) will be compared in terms of intercanine width, intermolar width, overjet, overbite and contact point displacement between the two groups at following time intervals. These parameters will be charted at T0, T1, T2,T3 and T4 for each patient. T0 - Baseline records, at the time of debonding. T1 - Records obtained at the time of retainer delivery. T2 - Records obtained after 1 month of retainer delivery. T3 - Records obtained after 3 months of retainer delivery. T4 - Records obtained after 6 months of retainer delivery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group-immediate retainer delivery | Other | Other: immediate orthodontic retainer deliveryRetainer will be given to the patients immediately [Just after debonding]. |
| experimental group-delayed retainer delivery | Active comparator | Other: delayed orthodontic retainer deliveryRetainer will be delivered to the patients 3 days post debonding. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adult orthodontic patients treated with 022*028 MBT appliance with following sequence of wires- 014, 016, 16*22, 17*25, 19*25 NiTi followed by 19*25 SS.
- Treatment duration of 24-36 months with Optimal functional occlusion at end of treatment (PAR score >70%).
- Class I bimax and Class II div I with pre-treatment Little's irregularity index <6mm in both upper and lower arch.
- Nonsurgical and non-orthopedic patients.
- Non syndromic patients and no impaction of teeth except third molars.
Key exclusion criteria (6 listed)
- Subjects with incomplete orthodontic treatment.
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 |
|---|---|---|
| immediate orthodontic retainer deliverypost orthodontic treatment patients will be given orthodontic retainer immediately after debonding | Other | control group-immediate retainer delivery |
| delayed orthodontic retainer deliverypost orthodontic treatment patients will be given orthodontic retainer after 3 days of debonding | Other | experimental group-delayed retainer delivery |
Primary outcome
overjet
Time frame: T0-baseline on the day of debonding
sagittal distance between upper and lower incisors
overjet
Time frame: T1- 3 days after debonding
sagittal distance between upper and lower incisors
overjet
Time frame: T2- 1 month after debonding
sagittal distance between upper and lower incisors
overjet
Time frame: T3- 3 months after debonding
sagittal distance between upper and lower incisors
overjet
Time frame: T4- 6 months after debonding
sagittal distance between upper and lower incisors
contact point displacement
Time frame: T0-baseline on the day of debonding
displacement of contact points in anterior teeth
contact point displacement
Time frame: T1- 3 days after debonding
displacement of contact points in anterior teeth
contact point displacement
Time frame: T2- 1 month after debonding
displacement of contact points in anterior teeth
contact point displacement
Time frame: T3- 3 months after debonding
displacement of contact points in anterior teeth
contact point displacement
Time frame: T4- 6 months after debonding
displacement of contact points in anterior teeth
Overbite
Time frame: T0- Baseline on the day of debonding
vertical overlap of upper and lower incisors
Overbite
Time frame: T1- 3 days after debonding
vertical overlap of upper and lower incisors
Overbite
Time frame: T2- 1 month after debonding
vertical overlap of upper and lower incisors
Overbite
Time frame: T3- 3 months after debonding
vertical overlap of upper and lower incisors
Overbite
Time frame: T4- 6 months after debonding
vertical overlap of upper and lower incisors
Intermolar width
Time frame: T0-baseline on the day of debonding
transverse distance between the first molars
Intermolar width
Time frame: T1- 3 days after debonding
transverse distance between the first molars
Intermolar width
Time frame: T2- 1 month after debonding
transverse distance between the first molars
Intermolar width
Time frame: T3- 3 months after debonding
transverse distance between the first molars
Intermolar width
Time frame: T4- 6 months after debonding
transverse distance between the first molars
Intercanine width
Time frame: T0-baseline on the day of debonding
transverse distance between canine
Intercanine width
Time frame: T1- 3 days after debonding
transverse distance between canine
Intercanine width
Time frame: T2- 1 month after debonding
transverse distance between canine
Intercanine width
Time frame: T3- 3 months after debonding
transverse distance between canine
Intercanine width
Time frame: T4- 6 months after debonding
transverse distance between canine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate orthodontic retainer delivery and delayed orthodontic retainer delivery in people with Relapse, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 May 2023. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rekha sharma, MDS (7982391690 ext. +91, rajsringari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overjet (time frame: T0-baseline on the day of debonding). The study lists 25 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 30 May 2023.