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

NCT ID: NCT05009355

Last Updated: 2022-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-11
• Study Completion Date: 2022-12-21

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

Conditions

Vitamin C Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

experimental

A Group: Consisted of 20 patients who were treated with scaling and root planing in conjunction with 2g antioxidant Vit (C)

Group Type: EXPERIMENTAL

Vitamin C

Intervention Type: DRUG

antioxidant

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin C

antioxidant

Intervention Type: DRUG

Other Intervention Names

c retard

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Abeer hassan sharafuddin

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

abeer H Sharafuddin, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Abeer Hassan Sharafuddin

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

abeer H Sharafuddin, PhD

Role: CONTACT

abeer.hasan@dentistry.cu.edu.eg

00201284181671

Abeer H Sharafuddin, PhD

Role: CONTACT

jabbar480@yahoo.com

00201284181671

Facility Contacts

abeer sharafuddin, master

Role: primary

abeersharafuddin@gmail.com

00201284181671

Other Identifiers

100200

Identifier Type: -

Identifier Source: org_study_id