Periodontal Health in Post COVID-19 Patients

NCT05950230 | Unknown

• 1 other identifier: Post COVID19
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is; To Assess the association between periodontal health and Matrix metalloproteinase-8 (MMP-8) level in Gingival Crevicular Fluid (GCF) in post COVID-19 patients.

Conditions

Post COVID-19 Condition

Keywords

Periodontal health; Gingival Crevicular Fluid (GCF); Matrix metalloproteinase-8 (MMP-8)

Outcome Measures

Primary Outcomes (2)

• Clinical Assessment

  Complete periodontal examination including the dentition status, numbers of present teeth, carious teeth, and missing teeth which including absent or indicated for extraction because of periodontal disease, and wasting diseases, such as abrasion and were recorded, followed by the recording of plaque scores, tooth mobility, gingival bleeding, probing depth (PD), recession (REC), and clinical attachment level (CAL) at six sites per tooth in all the teeth apart from the third molars using a unc-15 periodontal probe.

  Baseline

• Biochemical Assessment

  Each GCF sample will be evaluated forMMP-8 level using commercially available ELISA kits in accordance with the manufacturers' instructions.

  Baseline

Study Arms (2)

Cases

45 Patients with history and results of recovered COVID-19 infection.

Diagnostic Test: Assess Periodontal Health Status; Other: Collecte GCF samples by paperstrip

Control

45 Patients with negative history of COVID-19 infection.

Diagnostic Test: Assess Periodontal Health Status; Other: Collecte GCF samples by paperstrip

Interventions

Assess Periodontal Health Status DIAGNOSTIC_TEST

For all patients who are suitable for the study, the following clinical evaluation parameters will be recorded: * Plaque index (PI)(Silness and Löe, 1964). * Sulcus bleeding index(BOP)(Perez et al., 2008). * Probing depth (PD) (Polson et al., 1980). * Clinical attachment level (CAL) (Glavind and Löe, 1967). * Standardized Periapical Radiograph.

Cases; Control

Collecte GCF samples by paperstrip OTHER

GCF samples will be collected from all participating individuals to assess the levels of MMP-8 from the deepest periodontal pocket in the area. The sample areas will be insulated with cotton rolls, saliva contamination will be prevented, all supragingival plaque will be eliminated. The paper strips will placed into the periodontal pocket until resistance is felt and then permitted to remain for 30s(Offenbacher et al., 1984, Megson et al., 2010).

Cases; Control

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Case Group (Post-SARS-CoV-19) willinclude (n = 45) patients met the previous criteriaand had undergone (rRT-PCR) for the diagnosis of COVID-19 and recovered from all symptoms and finished isolation period or had negative rRT-PCR after infection(Yong, 2021, Marvisi et al., 2020, Liao et al., 2021, guidelines, 2021). Control Group (Non-SARS-CoV-19) willinclude (n = 45) patients met the previous criteria with no records of COVID-19 infection or suspicious symptoms.

You may qualify if:

• Both genders aged from 25-60.
• Systemically free(According to Cornell Medical Index-Health Questionnaire)(Pendleton et al., 2004).
• Having at least 20 teeth excluding third molars.
• Performing regular oral hygiene instructions.
• Patients with a current laboratory-confirmed SARS-CoV-2 infection after recovery time form Coronavirus who isolated themself at home (according to the Centers for Disease Control and Prevention (CDC) guidelines) until all of these things are true:(Jeong et al., 2021).
• Haven't had a fever for 24 hours without using a fever-reducing medicine.
• Symptoms are better, though they might not be totally gone.
• It's been at least 10 days since their symptoms started.
• Note that these recommendations do not apply to people with severe COVID-19 or with weakened immune systems (immunocompromised).
• For people who are asymptomatic (never develop symptoms): Isolation and precautions can be discontinued 10 days after the first positive viral test(Jeong et al., 2021).

You may not qualify if:

• Smoking and Smokeless tobacco use.
• Patients suffering from post-covid permanent complications (lung fibrosis- Mucormycosis, …...) in cases group.
• Patients having gingivitis.
• Status of pregnancy, lactation.
• Obese patients.
• Patients who have undergone any periodontal therapy in the last 6 months.
• Vulnerable groups of patients' e.g. (prisoners, handicapped patients and orphans).

Sponsors & Collaborators

• Ain Shams University: lead

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Related Links

• Czownicka, M., 2016. Determination of active matrix metalloproteinase 8 (aMMP-8) levels in the gingival crevicular fluid as a diagnostic test during periodontal maintenance therapy (Doctoral dissertation).
• Gaudin, A., Badran, Z., Chevalier, V., Aubeux, D., Prud'homme, T., Amador del Valle, G. and Cloitre, A., 2020. COVID-19 and Oral Fluids. Frontiers in Dental Medicine, 1, p.8.
• Lloyd-Jones, G., Molayem, S., Pontes, C.C. and Chapple, I., 2021. The COVID-19 pathway: a proposed oral-vascular-pulmonary route of SARS-CoV-2 infection and the importance of oral healthcare measures. J Oral Med Dent Res, 2(1), pp.1-25.
• Muñoz-Carrillo, José Luis, et al. "Pathogenesis of periodontal disease." Periodontal disease-diagnostic and adjunctive non-surgical considerations. IntechOpen, 2019.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival Crevicular Fluid (GCF) sample will be evaluated for MMP-8 level using commercially available ELISA kits in accordance with the manufacturers' instructions.

Study Officials

• Ola M. Ezzatt, Assoc.Prof.

  Associate Professor at Faculty of Dentistry, Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

RANDA N. ALZOUBI, Master

CONTACT

1554391506; RANDAALZOUBI@dent.asu.edu.eg

Yasmine A. Fouad, Lecturer

CONTACT

1005793929

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Dental Student

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 18, 2023
• Study Start: August 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share