The purpose of the present study was to evaluate the efficacy of low level laser Ga-Al-As on improvement of postoperative hypersensitivity after amamlgam restoration
Design
A randomized, double blinded, clinical trial(phase III) for 21 patients has been designed. Randomization is performed Based on the random numbers table obtained from www.randomizer.org.
Settings and conduct
This double-blind randomized clinical trial is conducted at Mashhad Dental School. Patient and evaluator of clinical signs and symptoms are not aware of the laser on or off.
Participants/Inclusion and exclusion criteria
Pregnancy and lactation
Spontaneous pain and nocturnal teeth and a history of swelling
Radiographic view with symptoms of periapical involvement (periodontal ligament dilatation, laminadora destruction, and radiolucent or radiopacic lesion)
The presence of faulty repairs (fractures, overhangs, orchantruses, caries)
The inability to attend laser treatment sessions for any reason
VAS>9
Tooth sensitivity for other reasons (gingival recession or decay or fractured tooth)
Pain in other teeth other than restored tooth
Intervention groups
The case group: treated with Ga-Al-As laser in 4 sessions with intervals of three days.The control group: the similar condition was applied except that the device was off.
Main outcome variables
postoperative sensitivity after amalgam restorations
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039318N4
Registration date:2019-01-18, 1397/10/28
Registration timing:retrospective
Last update:2019-01-18, 1397/10/28
Update count:0
Registration date
2019-01-18, 1397/10/28
Registrant information
Name
Ala Ghazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
ghazial@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-05-26, 1395/03/06
Actual recruitment start date
2016-01-21, 1394/11/01
Actual recruitment end date
2016-06-21, 1395/04/01
Trial completion date
2016-07-22, 1395/05/01
Scientific title
Evaluation of the treatment effect of low level laser Ga-Al-As on postoperative sensitivity after amalgam restorations
Public title
The effect of low level laser on postoperative sensitivity after amalgam restorations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient Satisfaction to Participate in the Study
Short-term sensitivity to various stimuli such as cold, heat, sweets, etc. After amalgam restorations (from restoration to two months afterwards)
Visual Analogue Scale less than 5
Exclusion criteria:
Pregnancy and lactation
Spontaneous pain and nocturnal teeth and a history of swelling
Radiographic view with symptoms of periapical involvement (periodontal ligament dilatation, laminadora destruction, and radiolucent or radiopacic lesion)
The presence of faulty repairs (fractures, overhangs, orchantruses, caries)
The inability to attend laser treatment sessions for any reason
VAS>9
Tooth sensitivity for other reasons (gingival recession or decay or fractured tooth)
Pain in other teeth other than restored tooth
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
20
Actual sample size reached:
21
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients are randomly divided into two groups, namely the Study and Control groups. Randomization is performed Based on the random numbers table obtained from www.randomizer.org.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the case group, laser therapy was performed . The control group was placed in the same conditions as the case group, and the machine beeps were simulated, but the laser device was silent.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
postoperative sensitivity after amalgam restorations
ICD-10 code
K03.89
ICD-10 code description
Other specified diseases of hard tissues of teeth
Primary outcomes
1
Description
postoperative sensitivity after amalgam restorations
Timepoint
immediately after treatment
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
postoperative sensitivity 3 and 6 months after amalgam restorations
Timepoint
3 and 6 months after treatment
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: treated with Ga-Al-As laser (810 nm, 200 mw ) in 4 sessions with intervals of three days.
Category
Treatment - Devices
2
Description
Control group: The control group was placed in the same conditions as the case group, and the machine beeps were simulated, but the laser device was silent.