The aim of this clinical study is comparative evaluation of two treatment methods including Nd:YAG laser and 40% Propolis gel to improve dentin hypersensitivity (DH) symptoms.
25 patients with DH are selected using simple sampling method. Sensitive teeth of one side are treated with Nd:YAG laser and those of the other side are treated with Propolis gel through split mouth design. The received treatment on each side of the Patients' mouth, will be determined through random numbers table. 12 patients receive laser treatment for their sensitive teeth in right side and propolis gel for their sensitive teeth in left side; and 13 patients contrariwise. Each patient receives three sessions with one week interval and is finally followed up by a blind specialist after one and three month. A Visual Analog Scale (VAS) is used to assess the amount of sensitivity at baseline, during and after treatment. Simulation of opposite side treatment in each side is in this way that fiber tip of laser device is held in off state in propolis treatment side with same time of laser treatment side and just the beep sound of device can be heard. Also the use of wet micro brush without impregnating with propolis in laser treatment side simulates the propolis application. So the study is carried out in double-blind situation. Inclusion criteria are having at least two hypersensitive teeth in two sides of mouth, no periodontal surgery within last 3 months and no desensitizing therapy within last 1 month. Patients who do not participate in all sessions are removed from this study. Finally the effect of tow treatments in decreasing DH will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111230858N1
Registration date:2017-03-23, 1396/01/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-23, 1396/01/03
Registrant information
Name
Maryam Rasti
Name of organization / entity
Shahid Sadoughi University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 35 3724 0171
Email address
dr.rasti68@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Yazd University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison between Nd:YAG laser and Propolis in treatment of dental sensitivity in patients with dentin hypersensitivity
Public title
effect of laser and Propolis in treatment of dentin hypersensitivity
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
having at least two hypersensitive teeth in two sides of mouth (one right and one left); age of ≥18 years; vitality of examined teeth; no carious lesions; fractures or cracks and restorations in examined teeth
exclusion criteria:
patient absent in fallow up appointments; systemic diseases; Pregnancy; periodontal surgery within last 3 months; orthodontic treatment in that same course; desensitizing therapy within last 1 month; existing of pulpitise and crown in examined teeth
Age
From 18 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is done using random numbers table to determine the kind of treatment in right or left side of patients' mouth. Therefore some patients receive laser treatment in right and Propolis gel in left side, and other patients receive conversely treatment. Because of one type treatment on right sensitive teeth and one other type on left sensitive teeth in each patient, this design study is called split mouth.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Central Organism of Medical University of Yazd, Shahid Bahonar Square, Yazd
City
Yazd
Postal code
8916978477
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.SSU.REC.1395.136
Health conditions studied
1
Description of health condition studied
dentin hypersensitivity
ICD-10 code
K03.8
ICD-10 code description
Other specified diseases of hard tissues of teeth
Primary outcomes
1
Description
dentin hypersensitivity
Timepoint
before treatment and immediately after, one week after, two weeks after, one month after and finally three months after treatment
Method of measurement
VAS (visual analog scale)
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
laser radiation in cervical area of sensitive teeth in three sessions with one week intervals.
Nd:YAG laser with 1064 nanometer wavelength, 1W power, 10 Hz frequency, short pulse mode, 300μm fiber tip was used for a time of 60 sec on each tooth.
Category
Treatment - Devices
2
Description
40% Propolis gel applying in cervical area of sensitive teeth in three sessions with one week interval
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School, Daheye Fajr Street, Yazd
Full name of responsible person
maryam Rasti
Street address
Dental School, Daheye Fajr Street, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Yazd University of Medical Sciences
Full name of responsible person
Dr. Amir Hooshang Mehrparvar
Street address
Department of Research and Technology, third floor of the University Central Building, South Shahid Sadughi street, Bahonar Square, Yazd
City
Yazd
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 of Yazd 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
dentistry collage of Yazd
Full name of responsible person
Maryam Rasti
Position
Postgraduate Student, Department of Operative Dentistry
Other areas of specialty/work
Street address
Dental School, Daheye Fajr Street, Yazd
City
Yazd
Postal code
Phone
+98 35 3625 0344
Fax
Email
marasti68@yahoo.com; dr.rasti68@gmail.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
dentistry collage of Yazd
Full name of responsible person
Maryam Rasti
Position
Postgraduate Student, Department of Operative Dentistry
Other areas of specialty/work
Street address
Dental School, Daheye Fajr Street, Yazd
City
Yazd
Postal code
Phone
+98 35 3625 0344
Fax
Email
marasti68@yahoo.com; dr.rasti68@gmail.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
dentistry collage of Yazd
Full name of responsible person
Maryam Rasti
Position
Postgraduate Student, Department of Operative Dentistry
Other areas of specialty/work
Street address
Dental school, Daheye Fajr Street, Yazd
City
Yazd
Postal code
8916978477
Phone
+98 353625881
Fax
Email
marasti68@yahoo.com; dr.rasti68@gmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)