Erectile Dysfunction, Periodontitis
Conditions
Keywords
Chronic periodontitis, Prognosis, Erectile Dysfunction
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).
Interventions
PROCEDURENon surgical periodontal therapy
single session full-mouth scaling and root planing
Sponsors
Tanta University
Taibah University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
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.
Eligibility
Sex/Gender
MALE
Age
30 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in the severity of Erectile Dysfunction | 3 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 between groups throughout the follow-up period in mean values of TNF-α level in serum . |
| changes in mean values of TNF-α in saliva | 3 momths | 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. |
| changes in mean values of Clinical attachment level | 3 months | 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). |
Outcome results
None listed