The aim of this study is to evaluate photo dynamic therapy with diode laser( 940 nm) on reduction of gingival inflammation around orthodontic brackets.The sample consists of 60 orthodontic patients having gingival enlargement with less than one millimeter distance to bracket. Scaling will be done for all patients and excess bonding material around brackets will be removed. Plaque Index, (GI) gingival index, (BOP) bleeding on probing, Probing depth and count of porphyromonas gingivalis bacteriae will be measured two weeks after scaling. Patients will be assigned randomly into 3 groups. Group 1 receives diode laser alone, group 2 receives methylene blue solution followed by diode laser, and control group receives placebo. All measurements will be repeated 4 weeks after intervention. Since the measurments is carried out by some one other than operator and also according to the fact that this person, patients and statistical analyzer will not be informed of the group in which the patients would be placed, this research is a triple blind study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404149085N4
Registration date:2015-10-31, 1394/08/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-31, 1394/08/09
Registrant information
Name
Amirfarhang Miresmaeili
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1823 9064
Email address
miresmaeili@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan university of medical science
Expected recruitment start date
2015-10-12, 1394/07/20
Expected recruitment end date
2016-04-21, 1395/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of photodynamic therapy with diode laser on reduction of gingival inflamation in fixed orthodontic patients -A randomized Clinical Trial
Public title
Treatment of gum inflammation with laser
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients under orthodontic treatment ( 12-30 years old) having gingival enlargement with less than one millimeter distance to bracket
Exclusion criteria: severe periodontal disease; pre existing systemic disease; existence of calculus.
Age
From 12 years old to 30 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Samples were randomly divided into three groups classified by gender.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Hamadan University of Medical Sciences
Street address
Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
65178-38677
Approval date
2015-01-01, 1393/10/11
Ethics committee reference number
IR.UMSHA.REC.1394.329
Health conditions studied
1
Description of health condition studied
Chronic gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
gingival index
Timepoint
4 weeks after intervention
Method of measurement
clinical
Secondary outcomes
1
Description
count of porphyromonas gingivalis bacteria
Timepoint
4 weeks after intervention
Method of measurement
polymerase chain reaction
Intervention groups
1
Description
Intervention group 1: The use of diode laser for reducing gingival inflammation; Diode laser with the wave length of 940 nm and the power of 1.5 w is radiated using a fiber with the diameter of 300nm. the radiation pulse is 20 ms/s. 0.5 mm of the head of the instrument is located in gingival sulcus and radiated 3 times in 15 seconds through the buccal gingival sulcus.
Category
Treatment - Devices
2
Description
Control group: The use of unpowered laser as placebo.
Category
Treatment - Drugs
3
Description
Intervention group 2: The use of diode laser with methylene blue for reducing gingival inflammation; One drop of 1% methylene blue solution is dropped in gingival sulcus and excess of the solution is washed off with water. Then diode laser with the wave length of 940 nm and the power of 1.5 w is radiated using a fiber with the diameter of 300nm. the radiation pulse is 20 ms/s. 0.5 mm of the head of the instrument is located in gingival sulcus and radiated 3 times in 15 seconds through the buccal gingival sulcus.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan University of Medical Sciences
Full name of responsible person
Dr Amirfarhang Miresmaeili
Street address
Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
School of Medicine, Shahid Fahmideh Street, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Amirfarhang Miresmaeili
Position
Associate Professor
Other areas of specialty/work
Street address
Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
65178-38677
Phone
+98 81 3823 9064
Fax
Email
miresmaeili@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Amirfarhang Miresmaeili
Position
Associate Professor
Other areas of specialty/work
Street address
Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
65178-38677
Phone
+98 81 3823 9064
Fax
Email
miresmaeili@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Amirfarhang Miresmaeili
Position
Associate Professor
Other areas of specialty/work
Street address
Orthodontic Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
65178-38677
Phone
+98 81 3838 1059
Fax
Email
miresmaeili@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)