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Status unknownNCT05009355Updated Mar 7, 2022

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

An Early Phase 1 interventional study of Vitamin C in Vitamin C Deficiency, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-07.

Sponsored by Cairo University · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Jan 2019, registered Aug 2021).
Phase
Early Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Vitamin C Deficiency

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03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's planned enrollment of 40 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • No intervention
    Control

    A Group: consisted of 20 patients who were treated with scaling and root planing.

Interventions

  • DrugVitamin C

    antioxidant

    Also known as: c retard

06

What researchers measure

Primary outcomes

  1. Total Oxidant Capacity

    unit

    Time frame: one month

Secondary outcomes

  1. Gingival index

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

    Time frame: one month

  2. plaque index

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

    Time frame: one month

  3. probing depth

    mm

    Time frame: one month

07

Study locations

1 of 1 sites recruiting
  • Abeer Hassan Sharafuddin
    Cairo, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05009355
Lead sponsor
Cairo University
Responsible party
Abeer hassan sharafuddin (lecturer, Cairo University) — Principal investigator
First posted
Aug 17, 2021
Start date
Jan 11, 2019
Primary completion
Sep 30, 2021
Completion
Dec 21, 2022 (estimated)
Last update
Mar 7, 2022

Study contacts

abeer H Sharafuddin, PhD
Contact
abeer.hasan@dentistry.cu.edu.eg
00201284181671
Abeer H Sharafuddin, PhD
Contact
jabbar480@yahoo.com
00201284181671
abeer H Sharafuddin, PhD
principal investigator · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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