UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of Vitamin C Supplementation on Plasma Vitamin C levels after Scaling and Rootplaning in Periodontitis-Smokers
Acronym	Vitamin C Supplementation on Plasma Vitamin C levels after SRP in Periodontitis-Smokers
Scientific Title	The Effect of Vitamin C Supplementation on Plasma Vitamin C Levels after Scaling and Rootplaning in Periodontitis-Smokers
Scientific Title:Acronym	The Effect of Vitamin C Supplementation on Plasma Vitamin C Levels after Scaling and Rootplaning in Periodontitis-Smokers : Vitamin C Supplementation on Plasma Vitamin C levels after SRP in Periodontitis-Smokers
Region	Asia(except Japan)

Condition
Condition	Healthy-adult smokers, with chronic periodontitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyse the effect of vitamin C supplementation and the impact of one visit full-mouth debridement (scaling and rootplaning)on plasma vitamin C levels in smokers with chronic periodontitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Plasma Vitamin C Levels
Key secondary outcomes	Periodontal Probing 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	The test group received scaling and rootplaning and 320 mg vitamin C (Ester C) once a day, 30 days before and after scaling and rootplaning (in total 60 days of supplementation)
Interventions/Control_2	The control group received scaling and rootplaning and placebo once a day, 30 days before and after scaling and rootplaning (in total 60 days of supplementation)
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. Systemically healthy adults; 2. > 30 years old and < 65 years old; 3. Being a smoker (10 cigarettes/day for more than 5 years); 4. Having chronic periodontitis (having pocket depth more than 5 mm at least at 2 teeth in maxilla and/or mandible)
Key exclusion criteria	1. had a systemic disease; 2. had a course of non steroidal anti inflammatory drugs or antimicrobial drugs within a 3-month period before the study began; 3. were pregnant or lactating; 4. used mouth-washes or vitamin supplements within the previous 3 months; 5. underwent periodontal treatment within a 3-month period before study began; 6. 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
Email	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
Email	amaliya@fkg.unpad.ac.id

Sponsor
Institute	Dental Faculty - Universitas Padjadjaran Indonesia Periodontology Departement
Institute
Department

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
Email	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 20 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	In the test group, plasma vitamin C levels significantly increased after supplementation and scaling and root planing did not have impact in decreasing these levels, whereas in the control group, plasma vitamin C levels did not elevate and after scaling and rootplaning it declined significantly.
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	Plasma vitamin C levels Probing pocket depth
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2019 Year 02 Month 09 Day
Date of IRB	2019 Year 03 Month 13 Day
Anticipated trial start date	2019 Year 12 Month 01 Day
Last follow-up date	2020 Year 03 Month 30 Day
Date of closure to data entry	2020 Year 04 Month 10 Day
Date trial data considered complete	2020 Year 04 Month 20 Day
Date analysis concluded	2020 Year 04 Month 30 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049516