| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Through journal requirements
- 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.
- 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.
|