| CTRI Number |
CTRI/2024/06/069684 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Association Between Chronic Periodontitis And Obstructive Sleep Apnea. |
|
Scientific Title of Study
|
Correlation Of Chronic Periodontitis And Obstructive Sleep Apnea -An Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanskriti Singh |
| Designation |
Post Graduate Student |
| Affiliation |
ITS Dental College Hospital and Research Centre |
| Address |
Room number 8, Department of Periodontics and Oral Implantology
ITS Dental College Hospital and Research Centre 47, Knowledge
Park-III Greater Noida
NIL
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8299766152 |
| Fax |
|
| Email |
sanskriti2023@its.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivesh Mishra |
| Designation |
Reader department of periodontics and oral implantology |
| Affiliation |
ITS Dental College Hospital and Research Centre |
| Address |
ITS Dental College Hospital and Research Centre 47, Knowledge
Park-III Greater Noida 47, Knowledge Park-III Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9953579219 |
| Fax |
|
| Email |
dr.shiveshmishra@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivesh Mishra |
| Designation |
Reader Department of Periodontics and Oral Implantology |
| Affiliation |
ITS Dental College Hospital and Research Centre |
| Address |
ITS Dental College Hospital and Research Centre 47, Knowledge
Park-III Greater Noida 47, Knowledge Park-III Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9953579219 |
| Fax |
|
| Email |
dr.shiveshmishra@its.edu.in |
|
|
Source of Monetary or Material Support
|
| ITS Dental College Hospital and Research Centre Greater Noida
|
|
|
Primary Sponsor
|
| Name |
ITS Dental College Hospital and Research Centre Greater Noida |
| Address |
47, Knowledge Park III, Greater Noida Uttar Pradesh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanskriti Singh |
ITS Dental College Hospital and Research Centre Greater Noida |
Department of Periodontics and oral implantology
ITS Dental College
Hospital and Research
Centre
Gautam Buddha Nagar
UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
8299766152
sanskriti2023@its.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS Dental College Hospital and Research Centre Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with chronic periodontitis according to AAP 1997 classification.
2.Both genders included.
3.Patients diagnosed with Obstructive Sleep Apnea by Polysomnography(PSG).
4.Age group between 20-45 years.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating females
2.Patients on Hormone Replacement Therapy
3.Patients receiving immunosuppressive drug therapy
4.Patients with deleterious habits
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To correlate interrelationship between Chronic Periodontitis and Obstructive Sleep Apnea.
2. To estimate the severity of Sleep Apnea impact on the Chronic Periodontitis.
3. To evaluate & correlate sleep indices with Mallampati Index.
|
6 Months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and correlate sleep indices with Stop/Bang Berlin questionnaire. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/07/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ThiThis study will provide valuable information about your periodontal health.
A significant association was observed between obstructive sleep apnea and
periodontitis. Low oxygen saturation might be a predictive index for
periodontitis, suggesting that hypoxia caused by obstructive sleep apnea might be related to
the symptoms of periodontitis. Number of patients is 20, Clinical Parameters
evaluation at baseline Gingival index (GI) (Loe H. and Silness P., 1963) Pocket probing depth
record. Plaque index (Silness P., Loe H 1964) Mallampati index/ score. Clinical attachment loss (CAL). Stop Bang / Berlin Questionnaire. Epworth sleepiness scale. The aim of the study is to correlate a
relationship between stages of periodontal diseases & patients afflicted
with Obstructive Sleep Apnea. As this study uses Polysomnography, a Gold
Standard for diagnosis of Sleep Apnea, to correlate it with different stages of
Periodontitis, it will give highly reliable results which can be used in the
diagnosis and management of periodontitis patients in Obstructive Sleep Apnea.
|