The Effect of Vitamin C on GCF Total Oxidant Capacity in Smoker Patients With Periodontitis

March 4, 2022 updated by: Abeer hassan sharafuddin, Cairo University

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

The effect of vitamin C supplementation on GCF total oxidant capacity in smoker patients with periodontitis following non-surgical periodontal therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: experimental
A Group: Consisted of 20 patients who were treated with scaling and root planing in conjunction with 2g antioxidant Vit (C)
Drug: Vitamin C
antioxidant
Other Names:
  • c retard
NO_INTERVENTION: Control
A Group: consisted of 20 patients who were treated with scaling and root planing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Oxidant Capacity
Time Frame: one month
unit
one month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gingival index
Time Frame: one month
score (0 is good no bleeding 3 is worst spontaneous bleeding )
one month
plaque index
Time Frame: one month
score (0 is good no plaque 3 is the worst )
one month
probing depth
Time Frame: one month
mm
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: abeer H Sharafuddin, PhD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 100200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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