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

The Effects of Non -Surgical Periodontal Treatment on The Severity of Erectile Dysfunction (Randomized Controlled Clinical Trial)

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Erectile Dysfunction
• Intervention / Treatment: Procedure: Non surgical periodontal therapy

Detailed Description

there no sufficient data to determine a possible link between erectile dysfunction ( ED) and periodontitis. Therefore, the purpose of this clinical trial is to study the influence of periodontal therapy (non-surgical) on the severity of ED among patients with chronic periodontitis and moderate or severe ED.

Sample size: The total number of patients in the current trial will be 140 to requite dropout rate during follow-up period.

Patients and study design:

The current trial is a single-blinded, randomized, parallel, controlled clinical study.

The patients with severe or moderate ED will selected from attendants of Andrology Outpatients Clinic, Tanta University Hospital and will referred to Periodontology Department, Tanta University. Statistical software (STATA 13.1, Stata Corp, Texas, USA) will be used on study participants for random allocation that identify to which group the patients will enrolled, using 1:1 allocation ratio.

Intervention protocol The patients will included in this study if they met the inclusion criteria. The IIEF is an appropriate questionnaire that is used for assessment of men sexual function, especially the ED. . Subjects with scores > 25 will assessed as men with normal sexual function while those with scores ≤ 25 will diagnosed as patients with ED. Following this, participants will directed to periodontology department to assess their periodontal health . After periodontal screening, all eligible patients will informed of potential risks, study objective, and benefits of their participation in this study. Non-surgical periodontal treatment that will be performed by the same periodontist for all participants within a test group at baseline and after three months for patients in a control group. Therefore, no periodontal treatment will be performed during the follow-up period in control group. D

Clinical and periodontal evaluation Thorough medical history, data on age, gender and socio-demographic characteristics will be gathered for all participants in studied groups at baseline. A full-mouth periodontal screening will be carried out by one specialist using a manual probe (Hu-Friedy, Chicago, IL, USA). Prior the current study, test-retest exercises will be performed in 20 patients to assess intra-examiner calibration. The periodontal parameters will be assessed at baseline and at 3 months that consist of PD, CAL, visible dental plaque (will be assessed at 4 sites per each tooth using a probe and will be recorded as present or absent) and bleeding on probing (BOP) (will be recorded as ratio of sites displaying bleeding after light probing) 10. After exclusion of third molars; for each tooth BOP, CAL and PD will be monitored at 6 sites. The IIEF scores will be recorded at baseline and 3 months for both groups.

Cytokine collection and evaluation:

Quantitative assessment of TNF-α in saliva and serum will be done by commercially available kit (Ray Bio Human TNF-α Enzyme Immunoassay).

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: test group; Non-surgical periodontal treatment consisted of oral hygiene instructions (OHI), single session full-mouth scaling and root planing (SRP)	Procedure: Non surgical periodontal therapy; single session full-mouth scaling and root planing
NO_INTERVENTION: control group; no periodontal treatment was performed during the follow-up period in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	changes between groups throughout the follow-up period in mean values of TNF-α level in serum .	3 months
changes in mean values of TNF-α in saliva	changes between groups throughout the follow-up period in mean values of TNF-α level in saliva .Quantitative assessment of TNF-α in saliva and serum was done by a commercially available kit (Ray Bio Human TNF-α Enzyme Immunoassay). and was expressed as pg/mL.	3 momths
changes in mean values of Clinical attachment level	changes between groups throughout the follow-up period in mean values of Clinical attachment level (distance from the base of the pocket to cement-enamel junction) which measured in milmiters using a manual probe (Hu-Friedy, Chicago, IL, USA).	3 months

Collaborators and Investigators

• Sponsor: Taibah University
• Collaborators: Tanta University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2016
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (ACTUAL): October 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Prognosis; Erectile Dysfunction; Chronic periodontitis
• Additional Relevant MeSH Terms: Mental Disorders; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Periodontitis; Erectile Dysfunction
• Other Study ID Numbers: periodontal therapy and IIEF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No