| CTRI Number |
CTRI/2020/02/023138 [Registered on: 05/02/2020] Trial Registered Prospectively |
| Last Modified On: |
22/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Outcomes of non surgical gum therapy in men with infertility |
|
Scientific Title of Study
|
Effect of non-surgical periodontal therapy among men diagnosed with infertility - A Randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manikandan N |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Dental Sciences,Manipal Manipal |
| Address |
Room no 3
Department of periodontology
MCODS Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8682891009 |
| Fax |
|
| Email |
n.manee11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jothi M Varghese |
| Designation |
Associate Professor |
| Affiliation |
Manipal college of Dental sciences,Manipal |
| Address |
Room no 3
Department of periodontology
MCODS Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845208532 |
| Fax |
|
| Email |
jothi.v@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jothi M Varghese |
| Designation |
Associate Professor |
| Affiliation |
Manipal college of Dental sciences,Manipal |
| Address |
Room no 3
Department of periodontology
MCODS Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845208532 |
| Fax |
|
| Email |
jothi.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Self Funded.
Dr Manikandan N
Department of Periodontology
MCODS,Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Manikandan N |
| Address |
Room no 3
Department of Periodontology
MCODS,Manipal |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Manipal University |
Manipal University,Manipal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manikandan N |
KMC,Manipal |
Department of Urology
Udupi
KARNATAKA |
8682891009
n.manee11@gmail.com |
| Dr Manikandan N |
Manipal college of dental sciences |
Room no: 3
Department of Periodontology
Udupi
KARNATAKA |
8682891009
n.manee11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N469||Male infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non surgical therapeutic intervention |
Patients will be receiving scaling and root planing and to find the effect on patients with infertility using biomarker level,antioxidant and clinical parameters |
| Comparator Agent |
Oral hygiene instructions |
Patients will be receiving oral hygiene instructions and to find the effect on patients with infertility using biomarker level,antioxidant and clinical parameters. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Male patients diagnosed with infertility
Diagnosed with gingivitis or periodontitis
Devoid of oral infections/diseases
Patients who are systemically healthy
Patients having grade I and II variocele
|
|
| ExclusionCriteria |
| Details |
Family history of infertility
History of periodontal therapy within 3 months
Exposure to antibiotics within preceeding 6 months
Patients with azoospermia
Consumption of alcohol or smoking
Patients having testicular abnormalities |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of non-surgical periodontal therapy in men with male factor infertility will be evaluated by assessing the change in biochemical,andrological and clinical parameters. |
Baseline,3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
By the result of primary outcome,patients will understand the link between oral health and systemic conditions and this awarness will help the patients maintaining their oral health
|
Baseline, 3months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/02/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized,parallel group,prospective design .Male patients visiting the department of Urology KMC Manipal, diagnosed with male factor infertility (MFI), As per the assesment by andrological parameters like sperm cell (concentration, motility, morphology) and these patients will be considered as the potential participants in this trial. The subjects will undergo oral examination and those matching the inclusion criteria will be included in this study. The subjects voluntarily willing to participate will be explained about the details of the study and an informed consent will be obtained. Following which the patients will be randomly allocated into two groups. Randomization will be done using block randomization with a block size of 4 samples with an allocation ratio of 1:1. Randomization will be done manually by using sequentially numbered opaque envelopes for treatment allocation into 9 blocks with each block containing 4 codes of samples. All patients will receive the standard therapy for infertility as per the protocol of department of urology. Group 1 Treatment group (TG) and Group 2 control group (CG) will be based on the periodontal non- surgical therapeutic intervention or only oral hygiene instructions. For every patient detailed case history and periodontal parameters - Plaque index (Silness&Loe1964), Gingival index (Loe&Silness1963), Periodontal Probing Depth (PPD), Clinical Attachment Level (CAL) will be charted on a standard proforma. Additional investigation will involve analysis of salivary biomarker level (IL-1β) and antioxidant (Thiol) two ml of unstimulated saliva will be collected by asking the patient to sit in coachman’s position. Sample will be collected in Eppendorf tubes and refrigerate at -800c till further examination. Semen samples collected from the participants will be used for examining the biomarker levels of IL- 1ẞ and Thiol. In treatment group (TG), patients will be receiving scaling and/ or root planing depending on the periodontal status i.e. Gingivitis and/or Periodontitis along with oral hygiene instructions. In control group (CG), patients will be given only oral hygiene instructions. |