Clinical trial NCT04129814: The Effects of Non -Surgical Periodontal Treatment on The Severity of Erectile Dysfunction
Official title: The Effects of Non -Surgical Periodontal Treatment on The Severity of Erectile Dysfunction (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Erectile Dysfunction
Keywords: Chronic periodontitis
Prognosis
Erectile Dysfunction
Lead sponsor: Taibah University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2019-10-17
Enrollment: 140
Sex: MALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: changes in the severity of Erectile Dysfunction
timeFrame: 3 months
Secondary outcomes:
measure: 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.
timeFrame: 3 months
measure: changes in mean values of TNF-α in saliva
timeFrame: 3 momths
measure: changes in mean values of Clinical attachment level
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: