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Vitamin C DeficiencyEarly Phase 1NCT05009355

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

A Early Phase 1 study testing Vitamin C in people with Vitamin C Deficiency, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Vitamin C Deficiency
What is being tested?
Vitamin C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
11 Jan 2019to 21 Dec 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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 .

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

abeer H Sharafuddin, PhD contact

00201284181671

abeer.hasan@dentistry.cu.edu.eg

Abeer H Sharafuddin, PhD contact

00201284181671

jabbar480@yahoo.com

Egypt1 site, 1 recruiting
  • Abeer Hassan Sharafuddin

    Cairo

    abeer sharafuddin, master, 00201284181671, abeersharafuddin@gmail.com

    Recruiting

Other trials in Egypt

About this study

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

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

Read the 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

Being tested
Vitamin C
Medical subject headings
Ascorbic Acid Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05009355
Study groupRoleWhat they receive
experimentalExperimentalA Group: Consisted of 20 patients who were treated with scaling and root planing in conjunction with 2g antioxidant Vit (C)
Receives: Drug: Vitamin C
ControlNo interventionA Group: consisted of 20 patients who were treated with scaling and root planing.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Oxidant Capacity

    unit

    Measured: one month

Secondary outcomes (3)
  1. Gingival index

    score (0 is good no bleeding 3 is worst spontaneous bleeding )

    Measured: one month

  2. plaque index

    score (0 is good no plaque 3 is the worst )

    Measured: one month

  3. probing depth

    mm

    Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2021
  2. Study start11 Jan 2019
  3. Primary completion30 Sep 2021
  4. Study completion21 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05009355
Sponsor's protocol ID
100200
Status last verified
Mar 2022
First submitted
2 Aug 2021
Last updated
7 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Vitamin C in people with Vitamin C Deficiency, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact abeer H Sharafuddin, PhD (00201284181671, abeer.hasan@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Oxidant Capacity (time frame: one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.

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