UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054396 |
|---|---|
| Receipt number | R000062133 |
| Scientific Title | COMPARATIVE EVALUATION OF COMPOSITE ANTERIOR BITE TURBOS AND SEQUENTIAL REVERSE CURVE OF SPEE ARCHWIRES IN THE TREATMENT OF DEEP OVERBITES- A RANDOMIZED CLINICAL TRIAL |
| Date of disclosure of the study information | 2024/05/14 |
| Last modified on | 2024/05/14 18:15:52 |
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Basic information
Public title
COMPARATIVE EVALUATION OF COMPOSITE ANTERIOR BITE TURBOS AND SEQUENTIAL REVERSE CURVE OF SPEE ARCHWIRES IN THE TREATMENT OF DEEP OVERBITES- A RANDOMIZED CLINICAL TRIAL
Acronym
COMPARISON OF COMPOSITE ABT AND SEQUENTIAL RCS ARCHWIRES IN THE TREATMENT OF DEEP BITE- A RCT
Scientific Title
COMPARATIVE EVALUATION OF COMPOSITE ANTERIOR BITE TURBOS AND SEQUENTIAL REVERSE CURVE OF SPEE ARCHWIRES IN THE TREATMENT OF DEEP OVERBITES- A RANDOMIZED CLINICAL TRIAL
Scientific Title:Acronym
COMPARISON OF COMPOSITE ABT AND SEQUENTIAL RCS ARCHWIRES IN THE TREATMENT OF DEEP BITE- A RCT
Region
| Asia(except Japan) |
Condition
Condition
Deep Overbite cases
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study was to compare the effects of composite anterior bite turbos and
sequential Reverse Curve of Spee archwires in fixed orthodontic patients with deep
overbite.
The primary objectives of the study were:
1) To compare two methods of deep overbite treatment: Anterior bite turbos and
sequential reverse curve of Spee archwires (RCS).
2) To evaluate angular and vertical changes of lower incisors and first molar.
3) To evaluate changes in the inclination of lower and upper incisors.
4) To evaluate vertical changes of the upper first molar.
Basic objectives2
Others
Basic objectives -Others
The secondary objectives of the study were:
1) To compare the duration of treatment between the two treatment procedures.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary objectives of the study were:
1) To compare two methods of deep overbite treatment: Anterior bite turbos and
sequential reverse curve of Spee archwires (RCS).
2) To evaluate angular and vertical changes of lower incisors and first molar.
3) To evaluate changes in the inclination of lower and upper incisors.
4) To evaluate vertical changes of the upper first molar.
Key secondary outcomes
The secondary objectives of the study were:
1) To compare the duration of treatment between the two treatment procedures.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Composite anterior bite turbos
Interventions/Control_2
Sequential reverse curve of spee archwires
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Increased overbite.
Mild skeletal discrepancy.
Average growth pattern.
No missing or extracted lower teeth
Key exclusion criteria
Patients who had already undergone orthodontic treatment.
Individuals with decreased oral hygiene.
Deteriorated periodontal condition.
Extraction of lower teeth
Extrusive mechanics i.e. headgear, functional appliance, expansion appliance, and
intermaxillary elastics should not be included in the treatment plan
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Prachee |
| Middle name | |
| Last name | Rishi |
Organization
ITS centre of dental studies and research
Division name
Department of orthodontics and dentofacial orthopedics
Zip code
201206
Address
ITS Centre for dental studies and research Delhi Meerut Road Muradnagar Ghaziabad
TEL
9463533217
prachee2512@gmail.com
Public contact
Name of contact person
| 1st name | Prachee |
| Middle name | |
| Last name | Rishi |
Organization
ITS college of dental studies and research
Division name
Department of orthodontics and dentofacial orthopedics
Zip code
201206
Address
ITS Centre for dental studies and research Delhi Meerut Road Muradnagar Ghaziabad
TEL
9463533217
Homepage URL
prachee2512@gmail.com
Sponsor or person
Institute
ITS Centre for dental studies and research Delhi Meerut Road Muradnagar Ghaziabad
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ITS Centre for dental studies and research
Address
ITS Centre for dental studies and research Delhi Meerut Road Muradnagar Ghaziabad
Tel
9463533217
prachee2512@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 14 | Day |
Last modified on
| 2024 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062133
