| CTRI Number |
CTRI/2019/02/017619 [Registered on: 12/02/2019] Trial Registered Prospectively |
| Last Modified On: |
24/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Gum Disease and Diabetes before and after laser treatment |
|
Scientific Title of Study
|
SALIVARY CALPROTECTIN LEVELS IN PERIODONTITIS ASSSOCIATED WITH DIABETES MELLITUS AFTER LOW LEVEL LASER THERAPY AS AN ADJUNT TO SCALING AND ROOT PLANING - A RANDOMISED 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 Sai Ankitha Kamatham |
| Designation |
Postgraduate |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room no. 5,
Second floor,
Department of Periodontology,
Narayana Dental College and Hospital,
Chintareddypalem,
Nellore- 524003,
Andhra Pradesh,
India.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9908804548 |
| Fax |
|
| Email |
saiankitha.94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kumar Chava |
| Designation |
Professor and HOD |
| Affiliation |
Narayana Dental College |
| Address |
Room no. 5,
Second floor,
Department of Periodontology,
Narayana Dental College and Hospital,
Chintareddypalem,
Nellore- 524003,
Andhra Pradesh,
India.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9441978737 |
| Fax |
|
| Email |
chava7@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Kumar Chava |
| Designation |
Professor and HOD |
| Affiliation |
Narayana Dental College |
| Address |
Room no. 5,
Second floor,
Department of Periodontology,
Narayana Dental College and Hospital,
Chintareddypalem,
Nellore- 524003,
Andhra Pradesh,
India.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9441978737 |
| Fax |
|
| Email |
chava7@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Self Funded
Sai Ankitha. Kamatham
Room no 5
Second floor
Department of Periodontology
Narayana Dental College and Hospital
Chintareddypalem
Nellore-524003
Andhra Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Sai Ankitha Kamatham |
| Address |
Department of Periodontics,
Narayana Dental College and Hospital, Chinthareddypalem,
Nellore |
| Type of Sponsor |
Other [self funded by principle investigator] |
|
|
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 |
| Sai Ankitha Kamatham |
Narayana Dental College and Hospital |
Room no 5,
second floor,
Department of Periodontology,
Narayana Dental College and Hospital, Chinthareddypalem,
Nellore-524003
Andhra Pradesh
India.
Nellore
ANDHRA PRADESH |
9908804548
saiankitha.94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low Level Laser therapy, scaling and root planning |
Participants aged 30 - 60 years based on inclusion and exclusion criteria will be selected from the department of periodontology Narayana dental hospital Nellore.All the participants will be explained about the aim, nature, and design of the study along with the written informed consent for their participation before the commencement of the study. Scaling and root planing is performed under local anesthesia by ultrasonic scalers, followed by low-energy-level diode laser(630-670nm) will be applied externally with a light contact to the gingival tissues corresponding to pockets in apico-coronal direction for 15s per site, scanning both lingual and buccal side. Oral hygiene instructions were given to participants.
|
| Comparator Agent |
scaling and root planing |
Participants aged 30 - 60 years based on inclusion and exclusion criteria will be selected from the department of periodontology Narayana dental hospital Nellore.All the participants will be explained about the aim, nature, and design of the study along with the written informed consent for their participation before the commencement of the study. Scaling and root planing is performed under local anesthesia by ultrasonic scalers. Oral hygiene instructions were given to participants.
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
periodontitis with a probing pocket depth(PPD) ≥5 mm, clinical attachment level (CAL)≥ 2mm.
patients with periodontitis and diabetes
|
|
| ExclusionCriteria |
| Details |
Participants taking medication from past 3 months excluding diabetes medications were excluded from the study
Pregnancy, lactating women
Patients underwent surgical or nonsurgical therapy within 6 months prior to the study.
Patients with any autoimmune disorders (such as rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease, psoriasis, refractory asthma)
Patients with oro-mucosal abnormalities
Patients with the usage of tobacco and alcohol in any form |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weather salivary calprotectin levels got reduced by using laser along with scaling and root planing and scaling and root planing in type 2 diabetes mellitus patients with periodontitis. |
baseline and 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to asses clinical parameters following laser therapy as an adjunct to scaling and root planing |
baseline and 8th week |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/06/2019 |
| Date of Study Completion (India) |
01/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomized clinical trial will be conducted by the Department of Periodontology, Narayana dental college and hospital, Nellore, Andhra Pradesh, India.
Participants aged 30 - 60 years based on inclusion and exclusion criteria were selected from the department of periodontology Narayana dental hospital Nellore before the commencement of the study.
All the participants will be explained about the aim, nature, and design of the study along with the written informed consent for their participation before the commencement of the study.
An assessment of PPD, CAL, BI (Muhlemann & Son), PI (silness and loe) was done using UNC-15 probes Hu-friedy’s. Patients will be grouped into
Group A: Participants with periodontitis alone
Group B: Participants with periodontitis and with type II diabetes
Group A1: Participants of group A receiving SRP (Scaling & root planning) alone
Group A2: Participants of group A receiving SRP + LLLT (Low-Level Laser Therapy)
Group B1: Participants of group B receiving SRP (Scaling & root planning) alone
Group B2: Participants of group B receiving SRP + LLLT (Low-Level Laser Therapy)
Scaling and root planing is performed under local anesthesia by ultrasonic scalers in all groups, followed by low-energy-level diode laser(630-670nm) was applied externally with light contact to the gingival tissues corresponding to pockets in apico-coronal direction for 15s per site, scanning both lingual and buccal side in group A2 and group B2. Oral hygiene instructions were given to participants.
Three milliliters of unstimulated whole expectorated saliva will be collected from each participant into sterile 5ml saliva collecting tubes and samples was stored at -80 degree centigrade.
Participants will be recalled after 8 weeks, saliva is collected in sterile 5ml collecting tube and stored at -80 degree centigrade and calprotectin levels will be determined by ELISA technique
All the parameters will be subjected for statistical analysis after completion of the study to evaluate and compare. |