| CTRI Number |
CTRI/2019/02/017737 [Registered on: 20/02/2019] Trial Registered Prospectively |
| Last Modified On: |
15/02/2019 |
| 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 after low laser treatment |
|
Scientific Title of Study
|
Salivary TNF-alpha levels in periodontitis associated with diabetes mellitus after Low level laser therapy as an adjunct 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 Pulivarthi Praneetha |
| Designation |
Postgraduate |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room no. 5, Second Floor, Department of Periodontology, Narayana Dental College and Hospital, Chinthareddypalem, Nellore-524003, Andhra Pradesh ,India.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
7095217673 |
| Fax |
|
| Email |
ppraneetha1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kumar Chava |
| Designation |
Professor and HOD |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room no. 5, Second Floor, Department of Periodontology, Narayana Dental College and Hospital, Chinthareddypalem, 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 and Hospital |
| Address |
Room no. 5, Second Floor, Department of Periodontology, Narayana Dental College and Hospital, Chinthareddypalem, 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
Pulivarthi Praneetha
Room no. 5, Second Floor, Department of Periodontology, Narayana Dental College and Hospital, Chinthareddypalem, Nellore-524003, Andhra Pradesh ,India. |
|
|
Primary Sponsor
|
| Name |
Pulivarthi Praneetha |
| Address |
Room no. 5, Second Floor, Department of Periodontology, Narayana Dental College and Hospital, Chinthareddypalem, Nellore-524003, Andhra Pradesh ,India. |
| 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 |
| Pulivarthi Praneetha |
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 |
7095217673
ppraneetha1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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 Planing |
Subjects aged between 30 -60 years with periodontitis, type 2 diabetes mellitus will be recruited from the outpatient, Department of Periodontology, Narayana Dental College and Hospital, Nellore, Andhra Pradesh
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 in all groups, followed by low-energy-level diode laser(630-670nm) was 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 in group A2 and group B2. Oral hygiene instructions were given to participants. |
| Comparator Agent |
Scaling and Root Planing |
Subjects aged between 30 -60 years with periodontitis, type 2 diabetes mellitus will be recruited from the outpatient, Department of Periodontology, Narayana Dental College and Hospital, Nellore, Andhra Pradesh.
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 in all groups 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 type 2 diabetes mellitus(diagnosed by RBS)
|
|
| ExclusionCriteria |
| Details |
Patients underwent laser therapy in the past 3 months.
Pregnancy, lactating women.
Patients underwent surgical or nonsurgical therapy within 6months prior to the study.
Patients who are deemed to be uncooperative.
Patients with any autoimmune disorders such as(rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease, psoriasis, refractory asthma)
Patients with Oro mucosal abnormalities.
Patients with tobacco habit in any form.
Prosthetic teeth.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Whether TNF- alpha levels get reduced by using laser along with scaling and root planing in type 2 diabetes mellitus patients with periodontitis |
base line and 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses clinical parametres following laser therapy as as adjunct to scaling and root planing |
Base line and 8th week |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 1 |
|
Date of First Enrollment (India)
|
01/06/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
A randomised clinical trial will be conducted by department of periodontology Narayana Dental College and Hospital Nellore, Andhra Pradesh, India Patients aged 30 - 60 years based on inclusion and exclusion criteria were selected from the Department of Periodontology, Narayana dental hospital Nellore, Andhra Pradesh. All the participants will be explained about the aim, nature and design of the study along with the written informed consent for their participation (Annexure) before the commencement of the study. An assessment of PPD, CAL, BIeeding index (BI) (Muhlemann & Son),Plaque Index (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 type 2 diabetes mellitus. Group A1: Participants of the group a receiving SRP (Scaling and Root planing) alone. Group A2: Participants of the group a receiving SRP + LLLT (Low-Level Laser Therapy). Group B1: Participants of group b receiving SRP (Scaling and Root Planing) 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 a 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 TNF-alpha levels will be determined by ELISA technique
All the parametres will be subjected for statistical analysis.
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