| CTRI Number |
CTRI/2024/12/078709 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Relation of periodontal inflammation with the effect of vitamin d supplement and low level laser therapy as addition to scaling and root planing in peridontitis patients with type 2 diabetes mellitus and vitamin d insufficiency |
|
Scientific Title of Study
|
Correlation of periodontal inflamed surface area with the effect of vitamin d supplement and low level laser therapy as an adjunct to scaling and root planing in periodontitis patients with type 2 diabetes mellitus and vitamin d insufficiency - a randomized controlled clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sphoorthi Anup Belludi |
| Designation |
Professor and Head |
| Affiliation |
KLES Institute of Dental Sciences |
| Address |
Department of Periodontics
K L E S Institute of Dental Sciences
# 20, Yeshwanthpur Suburb
Tumkur Road,Bangalore
Room No 5
Department Of Periodontics
K L E S Institute of Dental Sciences,Bangalore 560022
Bangalore
KARNATAKA
560022
India |
| Phone |
9916010380 |
| Fax |
|
| Email |
doc_sphoo@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sphoorthi Anup Belludi |
| Designation |
Professor and Head |
| Affiliation |
KLES Institute of Dental Sciences |
| Address |
Room no.5
Department Of Periodontics
KLES Institute of Dental Sciences
# 20, Yeshwanthpur suburb
tumkur road,Bangalore
Room no.5
Department Of Periodontics
KLES Institute of Dental Sciences,Bangalore 560022
Bangalore
KARNATAKA
560022
India |
| Phone |
9916010380 |
| Fax |
|
| Email |
doc_sphoo@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sphoorthi Anup Belludi |
| Designation |
Professor and Head |
| Affiliation |
KLES Institute of Dental Sciences |
| Address |
Room no.5
Department of Periodontics, KLES Institute of Dental Sciences
# 20,Yeshwanthpur suburb
tumkur road, Bangalore
Room no.5
Department of periodontics
KLES Institute of Dental Sciences
Bangalore 560022
Bangalore
KARNATAKA
560022
India |
| Phone |
9916010380 |
| Fax |
|
| Email |
doc_sphoo@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Room no.5 Department of periodontics, KLES Institute of Dental Scienes,#20, Yeshwanthpur suburb, tumkur road, Bangalore, Karnatata, India 560022 |
|
|
Primary Sponsor
|
| Name |
Sphoorthi Anup Belludi |
| Address |
Room no.5
Department of Periodontics
KLES Institute of Dental Sciences,#20, Yeshwanthpur suburb, Tumkur road, Bangalore -560022 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Sphoorthi Anup Belludi |
KLES Institute of Dental Sciences |
Room no.5
Department of periodontics
No.20,Yeshwanthpur suburb, Tumkur road Bangalore 560022
Bangalore
KARNATAKA |
9916010380
doc_sphoo@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee K L E societys institute of dental sciences Bangalore |
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 |
Scaling and root planing, Low level laser therapy and prescribing Vitamin D supplements. |
After thorough screening 60 subjects satisfying inclusion criteria and willing to participate in the study will be enrolled. Group 1 consist of 15 subjects will undergo scaling and root planing and low level laser therapy and will be prescribed Vitamin D supplement. Group 2 consist of 15 subjects will be subjected to scaling and root planing and low level laser therapy application and placebo. Group 3 consist of 15 subjects will be subjected to scaling and root planing and sham and vitamin D supplement. Group 4 consist of 15 subjects will undergo scaling and will be subjected to sham and placebo.
Subjects will undergo scaling at baseline(before start of study), Low level therapy and SHAM application will be done on day 1, 2 and 7 after scaling, Vitamin D supplements and placebo will be given once a week for 10 weeks.
|
| Comparator Agent |
Scaling and root planing, SHAM( placebo low level laser therapy)
and Placebo Vitamin D supplements. |
After thorough screening 60 subjects satisfying inclusion criteria and willing to participate in the study will be enrolled. Group 1 consist of 15 subjects will undergo scaling and root planing and low level laser therapy and will be prescribed Vitamin D supplement. Group 2 consist of 15 subjects will be subjected to scaling and root planing and low level laser therapy application and placebo. Group 3 consist of 15 subjects will be subjected to scaling and root planing and sham and vitamin D supplement. Group 4 consist of 15 subjects will undergo scaling and will be subjected to sham and placebo. After thorough screening 60 subjects satisfying inclusion criteria and willing to participate in the study will be enrolled. Group 1 consist of 15 subjects will undergo scaling and root planing and low level laser therapy and will be prescribed Vitamin D supplement. Group 2 consist of 15 subjects will be subjected to scaling and root planing and low level laser therapy application and placebo. Group 3 consist of 15 subjects will be subjected to scaling and root planing and sham and vitamin D supplement. Group 4 consist of 15 subjects will undergo scaling and will be subjected to sham and placebo |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with minimum of 20 teeth
Patients with vitamin D insufficiency, stage 2, grade B or C periodontitis
Patients with type 2 diabetes mellitus with HbA1c range between 6.0% to 8.0% |
|
| ExclusionCriteria |
| Details |
Patients who undergone periodontal therapy in the past 6 months.
Patients on immunosuppressant, antibiotics or any form of supplement therapy 6 months prior to study.
current smokers, alcoholics, smokeless tobacco users.
Pregnant and lactating women.
Post menopausal women.
Patients with acute illness/ acute intraoral lesions.
Subjects with chronic systemic disease other than type 2 diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation and correlation of periodontal inflamed surface area in periodontitis patients with type 2 diabetes mellitus |
At baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation & correlation of Vitamin D & Low level laser therapy with periodontal inflamed surface area in periodontitis patients with type 2 diabetes mellitus. |
At 3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
09/01/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study is to evaluate and corelate periodontal inflamed surface area with the effect of Vitamin D supplement and low level laser therapy on HbA1c, serum Vitamin D levels and clinical parameters when used as an adjunct to scaling and root planing in non surgical management of Vitamin D insufficient stage 2 grade B or grade C periodontitis patients with type2 diabetes mellitus. The study population will consist of individuals of both genders, in the age group of 30 to 65 years who volunteer to participate in the study and also fulfill the inclusion and exclusion criteria, all the subjects will recruited after providing the participants with an information sheet, explaining the purpose, nature and design of the study and obtaining a written informed consent from the subjects choose for the study. After thorough screening 60 subjects of both sexes satisfying the inclusion criteria and willing to participate in the study will be enrolled. The subjects will then be randomly and equally assigned using computerized randomization into 4 groups. Group 1 consist of 15 subjects with grade b or grade C periodontitis DM2 and Vitamin D insufficiency will be subjected to scaling and root planing and low level laser therapy application and will be prescribed with Vitamin d supplement for once a week for 10 weeks, group 2 consist of 15 subjects will be subjected to scaling and low level laser therapy and placebo for once a week for 10 weeks, group 3 consist of 15 subjects will be subjected to scaling, sham and Vitamin D supplement once a week for 10 weeks, group 4 consis of 15 subjected to scaling and root planing and will be subjected to sham and placebo. Then assessing clinical parameters, serum vitamin D level and Hb1Ac at basline and 3 months after scaling and root planing in all 4 groups. |