The Effects of Non -Surgical Periodontal Treatment on The Severity of Erectile Dysfunction
Condition: Periodontitis; Erectile Dysfunction
MeSH terms: Periodontitis; Erectile Dysfunction
Study type: Interventional

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).
    

Intervention name(s): Non surgical periodontal therapy
Intervention type(s): Procedure
Intervention description(s): single session full-mouth scaling and root planing
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Chronic periodontitis; Prognosis; Erectile Dysfunction