| CTRI Number |
CTRI/2021/05/033447 [Registered on: 07/05/2021] Trial Registered Prospectively |
| Last Modified On: |
20/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effect of laser therapy and ozonated water on gum swelling in patients with fixed appliances to teeth. |
|
Scientific Title of Study
|
Comparison of laser therapy and ozonated water on gingival inflammation in orthodontic patients with fixed appliances. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SBindu priya |
| Designation |
Doctor |
| Affiliation |
CKS Theja Institute of Dental Sciences and Research |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, room number 7
Chadalawada nagar, Renigunta road, Tirupati
Chittoor
ANDHRA PRADESH
517506
India |
| Phone |
9010200700 |
| Fax |
|
| Email |
bindupriyas111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSVKala Vani |
| Designation |
Doctor |
| Affiliation |
CKS Theja Institute of Dental Sciences and Research |
| Address |
Department of Orthodontics and Dentofacial Orthopedics
Chadalawada nagar, Renigunta road, Tirupati
Chittoor
ANDHRA PRADESH
517506
India |
| Phone |
9010200700 |
| Fax |
|
| Email |
drsvkvani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
bindu priya |
| Designation |
Doctor |
| Affiliation |
CKS Theja Institute of Dental Sciences and Research |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, room no.7
Chadalawada nagar, Renigunta road, Tirupati
Chittoor
ANDHRA PRADESH
517506
India |
| Phone |
9010200700 |
| Fax |
|
| Email |
bindupriyas111@gmail.com |
|
|
Source of Monetary or Material Support
|
| CKS Theja Institute of Dental SCiences and Research, Chadalawada nagar, Renigunta road, Tirupati |
|
|
Primary Sponsor
|
| Name |
Bindu Priya |
| Address |
CKS Theja Institute of Dental Sciencces and Research |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Bindu Priya |
CKS Theja Institute of Dental Sciences and Research |
Department of Orthodontics and Dentofacial Orthopedics, room number 7, Chadalawada Nagar, Renigunta road, Tirupathi.
Chittoor
ANDHRA PRADESH |
9010200700
bindupriyas111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CKS Theja Institute of dental sciences and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Malocclusion and under fixed appliance treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Low level laser |
To compare the efficiency of low level laser in controlling gingival inflammation with ozonated water |
| Intervention |
Ozonated water |
To control gingival inflammation sub gingival ozone irrigation is done |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with at least 24 natural teeth and those under fixed orthodontic appliance treatment for 4 - 8 months |
|
| ExclusionCriteria |
| Details |
Any relevant medical history or under any medication that modifies the gingival status of an individual. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in gingival inflammation on both sides with greater decrease expected on low level laser side |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in gingival inflammation on both sides with greater decrease expected on low level laser side |
56 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
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)?
Response - NO
|
|
Brief Summary
|
Objectives
The
objective of the study was to evaluate and compare the clinical effects of
low-level laser therapy (LLLT) with subgingival ozone irrigation for
controlling gingival inflammation in fixed orthodontic appliances patients and
to correlate clinical parameters viz. gingival
index (GI), plaque index (PI), gingival bleeding index (GBI) with lactate dehydrogenase enzyme (LDH) in gingival crevicular
fluid (GCF).
Materials and Methods
Thirty
systemically healthy orthodontic patients with age range from 15-25 years were
selected. In each subject, upper right and left quadrants of mouth were
designated as control side and experimental sides respectively. Clinical
parameters, LDH enzyme activity were assessed on 0th day on both the
sides. Experimental side was irradiated with laser and control side was
irrigated with 0.01 mg/l ozonated water ("Kent Ozone Dental jet TY-
820"). Clinical parameters were again assessed on 7th, 14th,
and 28th day, and LDH levels in GCF were evaluated on 28th
day. |