UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043364 |
|---|---|
| Receipt number | R000049515 |
| Scientific Title | The Effect of Vitamin C Supplementation on Plasma TAOC after Scaling and Rootplaning in Smokers with Chronic Periodontitis |
| Date of disclosure of the study information | 2021/12/18 |
| Last modified on | 2021/02/18 13:32:11 |
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Basic information
Public title
The Effect of Vitamin C Supplementation on Plasma Total Antioxidant Capacity after Scaling and Rootplaning in Smokers with Chronic Periodontitis
Acronym
The Effect of Vitamin C supplementation on plasma TAOC after SRP in Smokers with CP
Scientific Title
The Effect of Vitamin C Supplementation on Plasma TAOC after Scaling and Rootplaning in Smokers with Chronic Periodontitis
Scientific Title:Acronym
The Effect of Vitamin C Supplementation on Plasma TAOC after Scaling and Rootplaning in Smokers with Chronic Periodontitis : The Effect of Vitamin C supplementation on plasma TAOC after SRP in Smokers with CP
Region
| Asia(except Japan) |
Condition
Condition
Systemically healthy adult smokers with chronic periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of vitamin C supplementation on plasma total antioxidant capacity levels in in smokers with chronic periodontitis after scaling and rootplaning
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
TAOC levels in plasma
Key secondary outcomes
pocket depth
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Subjects in test group received scaling and rootplaning and vitamin C supplementation (320 mg Ester C) once a day, for 60 days i.e. 30 days before scaling and rootplaning and 30 days after scaling and rootplaning.
Scaling and rootplaning were performed by one trained dentist in one visit debridement/procedure
Interventions/Control_2
Subjects in control group received scaling and rootplaning and placebo once a day, for 60 days i.e. 30 days before scaling and rootplaning and 30 days after scaling and rootplaning.
Scaling and rootplaning were performed by one trained dentist in one visit debridement/procedure
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Having chronic periodontitis with periodontal pocket > 5 mm at least affected 2 teeth in mandible and/or maxilla,
2. Have been a smoker (10 cigarettes/day) for > 5 year)
3. Systemically healthy,
4. Willing to participate
Key exclusion criteria
1. had a course of non steroidal anti inflammatory drugs or antimicrobial drugs within a 3-month period before the study began;
2. Were pregnant or lactating;
3. Used mouth-washes or vitamin supplements within the previous 3 months;
4. Underwent periodontal treatment within a 3-month period before study began;
5) were using any orthodontic or prosthodontic appliances.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Amaliya |
| Middle name | |
| Last name | Amaliya |
Organization
Dental Faculty - Universitas Padjadjaran Indonesia
Division name
Periodontology
Zip code
40132
Address
Jalan Sekeloa Selatan no. 1 Bandung - West Java
TEL
0062222504985
amaliya@fkg.unpad.ac.id
Public contact
Name of contact person
| 1st name | Amaliya |
| Middle name | |
| Last name | Amaliya |
Organization
Dental Faculty - Universitas Padjadjaran - Indonesia
Division name
Periodontology
Zip code
40132
Address
Jalan Sekeloa Selatan no. 1 Bandung 40132 - West Java
TEL
0062222504985
Homepage URL
amaliya@fkg.unpad.ac.id
Sponsor or person
Institute
Dental Faculty - Universitas Padjadjaran Indonesia
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Indonesia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Commitee of Universitas Padjadjaran
Address
Jalan Prof. Eijkman No. 38, 4th floor, West Wing, Bandung
Tel
0062222038697
etik.unpad@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
Dental and Oral Hospital Universitas Padjadjaran Indonesia
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 18 | 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
The test group showed a significant increase in TAOC level after vitamin C supplementation and had no significant decrease of TAOC after scaling and rootplaning (SRP), while control group had significant reduce of TAOC after SRP.
Results date posted
| 2021 | Year | 02 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None were reported
Outcome measures
TAOC plasma levels
Pocket depth
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 04 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 06 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 18 | Day |
Last modified on
| 2021 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049515
