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CTRI Number  CTRI/2024/11/076146 [Registered on: 01/11/2024] Trial Registered Prospectively
Last Modified On: 25/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   vitamin D supplementation in postmenopausal women with periodontitis 
Scientific Title of Study   Impact of Vitamin D supplementation in postmenopausal women with stage II periodontitis after nonsurgical periodontal therapy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepa Anumala 
Designation  Professor 
Affiliation  SIBAR Institute of dental sciences 
Address  SIBAR Institute of dental sciences, Department of periodontology, Takellapadu, Guntur
Department of periodontology, Takellapadu, Guntur
Guntur
ANDHRA PRADESH
522509
India 
Phone  9618501146  
Fax    
Email  drdeepaperio@sids.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Deepa Anumala 
Designation  Professor 
Affiliation  SIBAR Institute of dental sciences 
Address  SIBAR Institute of dental sciences, Department of periodontology, Takellapadu, Guntur
Department of periodontology, Takellapadu, Guntur

ANDHRA PRADESH
522509
India 
Phone  9618501146  
Fax    
Email  drdeepaperio@sids.ac.in  
 
Details of Contact Person
Public Query
 
Name  Deepa Anumala 
Designation  Professor 
Affiliation  SIBAR Institute of dental sciences 
Address  SIBAR Institute of dental sciences, Department of periodontology, Takellapadu, Guntur
Department of periodontology, Takellapadu, Guntur

ANDHRA PRADESH
522509
India 
Phone  9618501146  
Fax    
Email  drdeepaperio@sids.ac.in  
 
Source of Monetary or Material Support  
SIBAR institute of dental sciences, Takellapadu, Guntur, India pin code: 522509 
 
Primary Sponsor  
Name  Deepa Anumala 
Address  SIBAR institute of dental sciences, Takellapadu, Guntur, India pin code: 522509 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr A Deepa  SIBAR institute of dental sciences  Department of periodontology, Room no. 8, Takellapadu, Guntur,India,pincode:522509
Guntur
ANDHRA PRADESH 
9618501146

drdeepaperio@sids.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SIBAR institute of dental sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E559||Vitamin D deficiency, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nonsurgical periodontal therapy with Vitamin D supplementation   gingival index (GI), plaque index (PI), and pocket depth (PD), Alveolar crest height (ACH) and serum vitamin D levels after 3 months 
Comparator Agent  nonsurgical periodontal therapy without vitamin D supplements  gingival index (GI), plaque index (PI), and pocket depth (PD), Alveolar crest height (ACH) and serum vitamin D levels after 3 months 
 
Inclusion Criteria  
Age From  55.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Postmenopausal women with atleast 5 years of menopause will be chosen for the study.Women in good general health, not suffering from any systemic disorder or condition will be selected for the study.Women who practice routine brushing habits and chew on both sides.
 
 
ExclusionCriteria 
Details  Patients taking estrogen, corticosteroids, nonsteroidal anti-inflammatory drugs , antibiotics, vitamin D, lithium, thiazide diuretics, and thyroxine with in the past one month Patients suffering from kidney failure, diabetes mellitus, Paget’s disease, cardiac diseases which would interfere with bone metabolism and immune system. Patients who had undergone periodontal therapy with in past 6 months.Patients with third molars.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
serum vitamin D levels, alveolar crest changes  baseline, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
gingival index, plaque index, pocket depth  baseline, 3 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   09/11/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Through journal requirements

  6. For how long will this data be available start date provided 18-03-2025 and end date provided 18-03-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
    Increased bone resorption due to decreased sex hormones in the first decade after menopause is a common problem in women.  Increasing attention has been paid in recent years to moderate vitamin D deficiency especially in postmenopausal women.  Vitamin D role in periodontitis is biologically assosiated and supported by experimental and clinical evidence showing its influence on inflammation, bone metabolism.   Vitamin D affects both the immune system and the bone mineral mass, which may lead to progression of periodontal disease in post menopausal women. Recent systematic review, given by Machado et al. stated that 25-hydroxyvitamin D serum levels were significantly lower in chronic periodontitis patients compared with healthy controls. They also concluded that owing to the low number of studies, ascription of periodontitis and vitamin D levels after non-surgical periodontal treatment is not simple. Factors that influence 25-hydroxyvitamin D concentration have been evaluated with considerable attention.Postmenopausal women with osteoporosis had lower serum 25OHD3 levels compared with age-matched controls without osteoporosis. Lowered serum 25OHD3 was also associated with periodontal disease and elevated levels of RANKL and osteoprotegerin (OPG). Non-surgical periodontal therapy (NSPT) with scaling and root planing is the most common treatment of periodontitis, which results in improvement of periodontal parameters.  There is limited data on variations of vitamin D levels in postmenopausal women after NSPT with vitamin D supplements. Therefore, this study aimed to assess the association of Periodontal parameters like Gingival index(GI),Plaque index(PI)Pocket depth(PD),Alveolar Crest Height(ACH)  and serum vitamin D levels at baseline and 3 months in postmenopausal women with Stage II Peridontitis after Non surgical periodontal therapy with or without vitamin D supplementation.  
 
 
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