The Effects of Non -Surgical Periodontal Treatment on The Severity of Erectile Dysfunction

NCT04129814 | Completed

• 1 other identifier: periodontal therapy and IIEF
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present study is to study the influence of periodontal therapy (non-surgical) on the severity of erectile dysfunction(ED) among patients with chronic periodontitis and moderate or severe ED.

Conditions

Periodontitis; Erectile Dysfunction

Keywords

Chronic periodontitis; Prognosis; Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• changes in the severity of Erectile Dysfunction

  changes in the severity of Erectile Dysfunction diagnosed by International Index of Erectile Dysfunction between test and control groups. Subjects with scores \> 25 were assessed as men with normal sexual function while those with scores ≤ 25 were diagnosed as patients with erectile dysfunction.severe with a score from 6 to 10, moderate (11-16) and mild (17-25)

  3 months

Secondary Outcomes (3)

• changes in mean values of TNF-α in serum.Quantitative assessment of TNF-α in serum was done by a commercially available kit (Ray Bio Human TNF-α Enzyme Immunoassay),and was expressed as pg/mL.

  3 months

• changes in mean values of TNF-α in saliva

  3 momths

• changes in mean values of Clinical attachment level

  3 months

Study Arms (2)

test group

EXPERIMENTAL

Non-surgical periodontal treatment consisted of oral hygiene instructions (OHI), single session full-mouth scaling and root planing (SRP)

Procedure: Non surgical periodontal therapy

control group

NO INTERVENTION

no periodontal treatment was performed during the follow-up period in the control group.

Interventions

Non surgical periodontal therapy PROCEDURE

single session full-mouth scaling and root planing

test group

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 30 to 40 years
• Diagnosis with chronic periodontitis using the classification system of (Armitage, 1999)19 for periodontal diseases
• Presence of at least sixth permanent teeth excluding the third molars20
• Clinical attachment level (CAL) and pocket depth (PD) ≥4 mm in more than 30% of sites19
• Severe or moderate ED
• Male patients
• Married

You may not qualify if:

• Alcoholism and smokers
• Presence of any systemic disorders that may affect ED or periodontal health such as heart disease, diabetes mellitus, and hypertension18
• Antimicrobial therapies in the last 6 months
• Periodontal treatment in the last 6 months
• Drug therapy that may cause ED as side effects such as atenolol and hydrochlorothiazide

Sponsors & Collaborators

• Taibah University: lead
• Tanta University: collaborator

MeSH Terms

Conditions

Periodontitis; Erectile Dysfunction; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Statistical software (STATA 13.1, Stata Corp, Texas, USA) was used for random and equal stratification of the participants according to their mean values of IIEF, and this identify to which group the patients were enrolled, using 1:1 allocation ratio.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Model Details: After periodontal and medical screening, all eligible patients will informed of potential risks, study objective, and benefits of their participation in this study. Non-surgical periodontal treatment consisted of oral hygiene instructions (OHI), single session full-mouth scaling and root planing (SRP) that will be performed by the same periodontist using Gracey curettes (Hu-Friedy, Chicago, IL, USA) and ultrasonic apparatus (Cavitron Select SPC, Dentsply professional, New York, USA) for all participants within a test group at baseline and after three months for patients in a control group because of ethical reasons. Therefore, no periodontal treatment will be performed during the follow-up period in control group.

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 17, 2019
• Study Start: April 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 21, 2019

Record last verified: 2019-10