RelapseNCT06292364
Comparison of Retention Characteristics of Immediate vs Delayed Retainer Delivery Using 3D Digital Model Analysis
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
Retention has been defined as "the holding of teeth following orthodontic treatment in the treated position for the period of time necessary for the maintenance of the result". Controversies regarding retention regime exist due to lack of high quality evidence regarding duration, type and timing of different type… 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
- 5 Nov 2023to 5 Dec 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
- Subjects who required extraction.
- Optimal functional occlusion at end of treatment (PAR score >70%).
- Littles irregularity index (Pre-treatment <6mm in both upper and lower arch).
- Nonsurgical and non-orthopedic patients.
- Non syndromic patients and no impaction of teeth except third molars.
- Optimal periodontal condition and Good oral hygiene (probing depth <3mm, gingival index score <1
- Good compliance regarding retainer wear.
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
- Patients having antibiotic therapy within previous 3 months and used anti inflammatory drugs in the month before the study
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Pgids Rohtak
Rohtak, Haryana, 124001
Dr. Rekha Sharma, MDS, 8076190296, rajsringari@gmail.com
About this study
Official title: "Comparison of Retention Characteristics of Immediate vs Delayed Retainer Delivery Using 3 Dimensional Digital Model Analysis : A Prospective Clinical Trial "
Retention has been defined as "the holding of teeth following orthodontic treatment in the treated position for the period of time necessary for the maintenance of the result". Controversies regarding retention regime exist due to lack of high quality evidence regarding duration, type and timing of different type retainer.The present randomised controlled trial will be undertaken to assess the changes and compare if there is any difference in movement of teeth in post orthodontic treatment cases with immediate and delayed (post 7 days) delivery using beggs retainer and change in level of bone biomarker over 6 months period of retention .
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(Beggs wrap around retainer ) in one group and post 7 days retainer delivery( beggs wrap around retainer) 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 7 days of debonding
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | beggs wrap around Retainer will be given to the patients immediately [Just after debonding]. Receives: Other: immediate orthodontic retainer delivery |
| experimental group | Active comparator | beggs wrap around Retainer will be delivered to the patients 7 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 - 7 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 - 6 month 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 - 7 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 - 6 month 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 - 7 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 - 6 month 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 - 7 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 - 6 month after debonding
intercanine width
transverse distance between the canine
Measured: T0 - baseline on the day of debonding
intercanine width
transverse distance between the canine
Measured: T1 - 7 days after debonding
intercanine width
transverse distance between the canine
Measured: T2 - 1 month after debonding
intercanine width
transverse distance between the canine
Measured: T3 - 6 month after debonding
Secondary outcomes (4)
GCF - elisa
BALP AND CTX TYPE 1 BIOMARKER
Measured: Tb - 1 month before debonding
GCF - elisa
BALP AND CTX TYPE 1 BIOMARKER
Measured: T0 - on the day of debonding
GCF - elisa
BALP AND CTX TYPE 1 BIOMARKER
Measured: T1 - 1 week after debonding
GCF - elisa
BALP AND CTX TYPE 1 BIOMARKER
Measured: T2 - 1 month after debonding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start5 Nov 2023
- Primary completion5 Nov 2024 (estimated)
- Study completion5 Dec 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
- Non-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
- NCT06292364
- Sponsor's protocol ID
- PGIDS/BHRC/23/106
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2024
- Last updated
- 5 Mar 2024
- 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparison of Retention Characteristics of Immediate vs Delayed Retainer Delivery Using 3 Dimensional Digital Model Analysis : A Prospective Clinical Trial "
- ClinicalTrials.gov ID
- NCT06292364
- Acronym / sponsor ID
- PGIDS/BHRC/23/106
- 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
- 5 Nov 2023 (actual)
- Primary completion
- 5 Nov 2024 (estimated)
- Study completion
- 5 Dec 2024 (estimated)
- First posted
- 5 Mar 2024 (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.
Retention has been defined as "the holding of teeth following orthodontic treatment in the treated position for the period of time necessary for the maintenance of the result". Controversies regarding retention regime exist due to lack of high quality evidence regarding duration, type and timing of different type retainer.The present randomised controlled trial will be undertaken to assess the changes and compare if there is any difference in movement of teeth in post orthodontic treatment cases with immediate and delayed (post 7 days) delivery using beggs retainer and change in level of bone biomarker over 6 months period of retention .
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(Beggs wrap around retainer ) in one group and post 7 days retainer delivery( beggs wrap around retainer) 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: immediate orthodontic retainer deliverybeggs wrap around Retainer will be given to the patients immediately [Just after debonding]. |
| experimental group | Active comparator | Other: delayed orthodontic retainer deliverybeggs wrap around Retainer will be delivered to the patients 7 days post debonding. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects who required extraction.
- Optimal functional occlusion at end of treatment (PAR score >70%).
- Littles irregularity index (Pre-treatment <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 (7 listed)
- 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.
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 |
| delayed orthodontic retainer deliverypost orthodontic treatment patients will be given orthodontic retainer after 7 days of debonding | Other | experimental group |
Primary outcome
overjet
Time frame: T0 - baseline on the day of debonding
sagittal distance between upper and lower incisors
overjet
Time frame: T1 - 7 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 - 6 month 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 - 7 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 - 6 month 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 - 7 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 - 6 month 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 - 7 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 - 6 month after debonding
transverse distance between the first molars
intercanine width
Time frame: T0 - baseline on the day of debonding
transverse distance between the canine
intercanine width
Time frame: T1 - 7 days after debonding
transverse distance between the canine
intercanine width
Time frame: T2 - 1 month after debonding
transverse distance between the canine
intercanine width
Time frame: T3 - 6 month after debonding
transverse distance between the canine
4 secondary outcomes
GCF - elisa
Time frame: Tb - 1 month before debonding
GCF - elisa
Time frame: T0 - on the day of debonding
GCF - elisa
Time frame: T1 - 1 week after debonding
GCF - elisa
Time frame: T2 - 1 month after debonding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- 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 7 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. 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 Dr. Rekha sharma MDS (8076190296, 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 20 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 5 Mar 2024.