PeriodontitisNCT04129814
The Effects of Non -Surgical Periodontal Treatment on The Severity of Erectile Dysfunction
A study testing Non surgical periodontal therapy in people with Periodontitis and Erectile Dysfunction, run by Taibah University.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 40 years, men only
- Conditions the study is for
- Periodontitis, Erectile Dysfunction
- What is being tested?
- Non surgical periodontal therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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).
- Conditions
- Periodontitis, Erectile Dysfunction
- Being tested
- Non surgical periodontal therapy
- Keywords
- Chronic periodontitis, Prognosis, Erectile Dysfunction
- Medical subject headings
- Periodontitis, Erectile Dysfunction, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non surgical periodontal therapyProcedure or surgery
single session full-mouth scaling and root planing
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Non-surgical periodontal treatment consisted of oral hygiene instructions (OHI), single session full-mouth scaling and root planing (SRP) Receives: Procedure: Non surgical periodontal therapy |
| control group | No intervention | no periodontal treatment was performed during the follow-up period in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
changes between groups throughout the follow-up period in mean values of TNF-α level in serum .
Measured: 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.
Measured: 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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study startApr 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taibah University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, Yasser El Makaky, Taibah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129814
- Sponsor's protocol ID
- periodontal therapy and IIEF
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Non -Surgical Periodontal Treatment on The Severity of Erectile Dysfunction (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04129814
- Acronym / sponsor ID
- periodontal therapy and IIEF
- Conditions
- Periodontitis, Erectile Dysfunction
- Keywords
- Chronic periodontitis, Prognosis, Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Taibah UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- Apr 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Procedure: Non surgical periodontal therapyNon-surgical periodontal treatment consisted of oral hygiene instructions (OHI), single session full-mouth scaling and root planing (SRP) |
| control group | No intervention | –no periodontal treatment was performed during the follow-up period in the control group. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non surgical periodontal therapysingle session full-mouth scaling and root planing | Procedure or surgery | test group |
Primary outcome
changes in the severity of Erectile Dysfunction
Time frame: 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)
3 secondary outcomes
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.
Time frame: 3 months
changes in mean values of TNF-α in saliva
Time frame: 3 momths
changes in mean values of Clinical attachment level
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Non surgical periodontal therapy in people with Periodontitis and Erectile Dysfunction, run by Taibah University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in the severity of Erectile Dysfunction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.