UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054416 |
|---|---|
| Receipt number | R000062152 |
| Scientific Title | Molecular characterization of root resorption using Osteopontin in different intrusion methods |
| Date of disclosure of the study information | 2024/05/16 |
| Last modified on | 2024/05/16 18:18:06 |
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Basic information
Public title
Molecular characterization of root resorption using Osteopontin in different intrusion methods
Acronym
Molecular characterization of root resorption in different intrusion methods
Scientific Title
Molecular characterization of root resorption using Osteopontin in different intrusion methods
Scientific Title:Acronym
Molecular characterization of root resorption in different intrusion methods
Region
| Asia(except Japan) |
Condition
Condition
Root resorption in deep bite patients
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study was conducted with the following objectives:
1.To examine the levels for Ostepontin in GCF for root resorption in both treatment techniques through ELISA at different time intervals (prior to orthodontic treatment and after the levelling and alignment stage).
2. To examine and compare root resorption between two groups using periapical radiography (along with grid to measure root resorption) at two different time intervals.
Basic objectives2
Others
Basic objectives -Others
The study was conducted with the following objectives:
1.To examine the levels for Ostepontin in GCF for root resorption in both treatment techniques through ELISA at different time intervals (prior to orthodontic treatment and after the levelling and alignment stage).
2. To examine and compare root resorption between two groups using periapical radiography (along with grid to measure root resorption) at two different time intervals.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The study was conducted with the following objectives:
1.To examine the levels for Ostepontin in GCF for root resorption in both treatment techniques through ELISA at different time intervals (prior to orthodontic treatment and after the levelling and alignment stage).
2. To examine and compare root resorption between two groups using periapical radiography (along with grid to measure root resorption) at two different time intervals.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Anterior bite turbos
Interventions/Control_2
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
-Fixed orthodontic treatment with non-extraction of teeth
-Increased overbite suggestive of deepbite
-Average growth pattern and mild skeletal discrepancy
-No missing or extracted tooth
-No history of anti-microbial therapy
-No use of anti inflammatory drugs within the month preceding study.
-Healthy periodontal tissues with generalised probing depth with minimal bleeding.
-No radiographic evidence of periodontal bone loss.
Key exclusion criteria
-Subjects which are periodontally compromised.
-Patients with increased overjet
-Patients with previous orthodontic treatment
-Poor oral hygiene
-Pregnant or lactating females
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Prince |
| Middle name | |
| Last name | Bedi |
Organization
I.T.S- CENTRE FOR DENTAL STUDIES AND RESEARCH, MURAGNAGAR,GHAZIABAD
Division name
DEPARTEMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS
Zip code
201206
Address
I.T.S CENTRE FOR DENTAL STUDIES AND RESEARCH PG BOYS HOSTEL, MURADNAGAR, GHAZIABAD
TEL
9818705650
pbedi570@gmail.com
Public contact
Name of contact person
| 1st name | Prince |
| Middle name | |
| Last name | Bedi |
Organization
I.T.S- CENTRE FOR DENTAL STUDIES AND RESEARCH, MURAGNAGAR,GHAZIABAD
Division name
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS
Zip code
201206
Address
I.T.S CENTRE FOR DENTAL STUDIES AND RESEARCH PG BOYS HOSTEL, MURADNAGAR, GHAZIABAD
TEL
9818705650
Homepage URL
pbedi570@gmail.com
Sponsor or person
Institute
NIL
Institute
Department
Personal name
Funding Source
Organization
NIL
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
I.T.S- CENTRE FOR DENTAL STUDIES AND RESEARCH, MURAGNAGAR,GHAZIABAD
Address
I.T.S CENTRE FOR DENTAL STUDIES AND RESEARCH PG BOYS HOSTEL, MURADNAGAR, GHAZIABAD
Tel
9818705650
pbedi570@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 | 16 | 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 | 09 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 10 | 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 | 16 | Day |
Last modified on
| 2024 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062152
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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