The Effect of Vitamin C on GCF Total Oxidant Capacity in Smoker Patients With Periodontitis
Primary Purpose
Vitamin C Deficiency
Status
Recruiting
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin C
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin C Deficiency
Eligibility Criteria
Inclusion Criteria:
- all patients were systemically healthy
- stage III-IV grade B periodontitis
- A minimum of two non-adjacent teeth having sites with ≥ 5 mm interdental clinical attachment loss .
- Radiographic bone loss extending to middle third of root and beyond .
- All patients were heavy smokers i.e ≥ 20 cigarettes / day .
Exclusion Criteria:
- patients who had received any periodontal or antibiotic treatment or vitamins supplementation during the last six months.
- pregnant or lactating women
- patients who refused to provide written informed consent
Sites / Locations
- Abeer Hassan SharafuddinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental
Control
Arm Description
A Group: Consisted of 20 patients who were treated with scaling and root planing in conjunction with 2g antioxidant Vit (C)
A Group: consisted of 20 patients who were treated with scaling and root planing.
Outcomes
Primary Outcome Measures
Total Oxidant Capacity
unit
Secondary Outcome Measures
Gingival index
score (0 is good no bleeding 3 is worst spontaneous bleeding )
plaque index
score (0 is good no plaque 3 is the worst )
probing depth
mm
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05009355
Brief Title
The Effect of Vitamin C on GCF Total Oxidant Capacity in Smoker Patients With Periodontitis
Official Title
The Effect of Vitamin C Supplementation on GCF Total Oxidant Capacity in Smoker Patients With Periodontitis Following Non-surgical Periodontal Therapy. A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
December 21, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The effect of vitamin C supplementation on GCF total oxidant capacity in smoker patients with periodontitis following non-surgical periodontal therapy.
Detailed Description
All subjects were screened by comprehensive periodontal examination and full periodontal charts were obtained and full-mouth periapical radiographs were taken using the long cone parallel technique at the time of the initial examination to confirm the diagnosis.
Both groups (smokers with stage III-IV grade B periodontitis) received full mouth scaling and root planing using ultrasonic scaler and hand instruments under local anesthesia, completed over 2 visits. Patients were given careful instruction in self performed plaque control measures: twice daily tooth brushing with a brush and tooth paste and once daily interdental cleaning using triangular wooden tooth picks and/or interdental brushes rinsing with 0.125% Chlorhexidine HCL mouthwash (Hexitol® ) to be used twice daily for 2 weeks. Group II received antioxidant vit C 2 grams / day for four weeks.
Collection of gingival crevicular fluid (GCF) sample:
In both groups, GCF samples were collected at the initial visit and collected again 3 months after non-surgical treatment as follows : at the selected area (the most periodontally affected site), all clinically detected supragingival plaque were removed carefully to minimize contamination of the paper strips by the plaque . The teeth selected were then gently washed with water, and the sites under study were isolated with cotton rolls to prevent contamination with saliva and gently dried with an air syringe . Filter paper strips were placed at the entrance of the crevice and were left in place for 30 secs ) and then placed in plastic eppendorf. Strips with any plaque, saliva, or blood contamination were discarded .The sample from the individual site was stored at -80°C for later processing . GCF was then extracted and assayed for the content of total oxidant capacity.
Quantitation of TOC in GCF:
GCF samples of both groups were assayed using ELISA technique for estimation of the level of total oxidant capacity (TOC) in GCF as follows:
The TOC was extracted from the paper strip by adding 100 μl of phosphate buffer saline to the eppendorf tube then mixed by vortex followed by centrifugation for 10 min at 3000Xg. The supernatant was used for estimation of TOC. For the quantitative determination of human TOC concentrations in GCF, PerOx (TOS/TOC) Immun-diagnostik Assay (ELISA) Kit was used. ELISA is intended for the quantitative determination of the total oxidative status/capacity (TOS/TOC) in Ethylene-diaminetetraacetic acid (EDTA)-plasma, serum and cell culture supernatants.
The determination of the peroxides is performed by the reaction of a peroxidase with peroxides in the sample followed by the conversion of TMB (Tetra-methylbenzidine) to a colored product. After addition of a stop solution the samples were measured at 450 nm in a microtiter plate reader. The quantification is performed by the delivered calibrator
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin C Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental
Arm Type
Experimental
Arm Description
A Group: Consisted of 20 patients who were treated with scaling and root planing in conjunction with 2g antioxidant Vit (C)
Arm Title
Control
Arm Type
No Intervention
Arm Description
A Group: consisted of 20 patients who were treated with scaling and root planing.
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
c retard
Intervention Description
antioxidant
Primary Outcome Measure Information:
Title
Total Oxidant Capacity
Description
unit
Time Frame
one month
Secondary Outcome Measure Information:
Title
Gingival index
Description
score (0 is good no bleeding 3 is worst spontaneous bleeding )
Time Frame
one month
Title
plaque index
Description
score (0 is good no plaque 3 is the worst )
Time Frame
one month
Title
probing depth
Description
mm
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all patients were systemically healthy
stage III-IV grade B periodontitis
A minimum of two non-adjacent teeth having sites with ≥ 5 mm interdental clinical attachment loss .
Radiographic bone loss extending to middle third of root and beyond .
All patients were heavy smokers i.e ≥ 20 cigarettes / day .
Exclusion Criteria:
patients who had received any periodontal or antibiotic treatment or vitamins supplementation during the last six months.
pregnant or lactating women
patients who refused to provide written informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
abeer H Sharafuddin, PhD
Phone
00201284181671
Email
abeer.hasan@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Abeer H Sharafuddin, PhD
Phone
00201284181671
Email
jabbar480@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
abeer H Sharafuddin, PhD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abeer Hassan Sharafuddin
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
abeer sharafuddin, master
Phone
00201284181671
Email
abeersharafuddin@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Vitamin C on GCF Total Oxidant Capacity in Smoker Patients With Periodontitis
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