UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055282 |
|---|---|
| Receipt number | R000063167 |
| Scientific Title | The Effect of Intracanal Medicaments on the Healing of Apical Periodontitis |
| Date of disclosure of the study information | 2024/08/19 |
| Last modified on | 2024/08/19 21:52:18 |
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Basic information
Public title
The Effect of Intracanal Medicaments on the Healing of Apical Periodontitis
Acronym
Intracanal Medicaments on the Healing of Apical Periodontitis
Scientific Title
The Effect of Intracanal Medicaments on the Healing of Apical Periodontitis
Scientific Title:Acronym
Intracanal Medicaments on the Healing of Apical Periodontitis
Region
| Asia(except Japan) |
Condition
Condition
Apical Periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This observational study aims to evaluate the effect of intracanal medicaments, specifically calcium hydroxide and triple antibiotic paste, on the healing of apical periodontitis. By assessing parameters such as reduction in apical radiolucency, presence of periapical healing, bleeding on probing (BOP) percentage, Clinical Attachment Level (CAL), and periodontal depth, the study aims to provide a comprehensive understanding of the therapeutic effects of these medicaments. Furthermore, the study will assess the sustainability of treatment outcome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome measure of this study was the healing of apical periodontitis, evaluated radiographically using periapical radiographs. Two calibrated observers independently assessed the radiographs for the reduction in apical radiolucency and the presence of periapical healing.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients were selected through non-probability convenient sampling, considering individuals aged between 18 and 65 years, with no systemic diseases affecting oral health
Key exclusion criteria
Exclusion criteria for this study included patients with systemic diseases affecting oral health, those on medications influencing healing, pregnant or lactating women, individuals with previous endodontic treatment within the last 6 months, teeth with severe periodontal disease or deemed non-restorable, patients with known allergies to study materials, and those unable to commit to the required follow-up schedule.
Target sample size
304
Research contact person
Name of lead principal investigator
| 1st name | Megha |
| Middle name | |
| Last name | Chethan |
Organization
KGF College of Dental Sciences, Kolar, IND
Division name
Department of Conservative Dentistry and Endodontics
Zip code
563115
Address
KGF College of Dental Sciences, Kolar, IND
TEL
9931413256
meghachethan@yahoo.co.in
Public contact
Name of contact person
| 1st name | Megha |
| Middle name | |
| Last name | Chethan |
Organization
KGF College of Dental Sciences, Kolar, IND
Division name
Department of Conservative Dentistry and Endodontics
Zip code
563115
Address
KGF College of Dental Sciences, Kolar, IND
TEL
9931413256
Homepage URL
meghachethan@yahoo.co.in
Sponsor or person
Institute
KGF College of Dental Sciences, Kolar, IND
Institute
Department
Personal name
Funding Source
Organization
KGF College of Dental Sciences, Kolar, IND
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
KGF College of Dental Sciences, Kolar, IND
Address
KGF College of Dental Sciences, Kolar, IND
Tel
9931413256
meghachethan@yahoo.co.in
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 | 08 | Month | 19 | Day |
Related information
URL releasing protocol
Yes
Publication of results
Unpublished
Result
URL related to results and publications
yes
Number of participants that the trial has enrolled
215
Results
yes
Results date posted
| 2024 | Year | 08 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
yes
Participant flow
yes
Adverse events
yes
Outcome measures
yes
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation of healing of apical periodontitis
Management information
Registered date
| 2024 | Year | 08 | Month | 19 | Day |
Last modified on
| 2024 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063167
