NCT05009355

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2019

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2019

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2022

Completed
Last Updated

March 7, 2022

Status Verified

March 1, 2022

Enrollment Period

2.7 years

First QC Date

August 2, 2021

Last Update Submit

March 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total Oxidant Capacity

    unit

    one month

Secondary Outcomes (3)

  • Gingival index

    one month

  • plaque index

    one month

  • probing depth

    one month

Study Arms (2)

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

Control

NO INTERVENTION

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

Interventions

antioxidant

Also known as: c retard
experimental

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abeer Hassan Sharafuddin

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Ascorbic Acid Deficiency

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • abeer H Sharafuddin, PhD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

abeer H Sharafuddin, PhD

CONTACT

Abeer H Sharafuddin, PhD

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

August 2, 2021

First Posted

August 17, 2021

Study Start

January 11, 2019

Primary Completion

September 30, 2021

Study Completion

December 21, 2022

Last Updated

March 7, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations