This study investigated the effect of postoperative 660 nm Low-Level Laser Therapy (LLLT) on the radiographic crestal bone loss of fresh socket implants.
Design
This study is a double blind clinical trial with two arm parallel groups. Thirty patients were randomly divided into two groups: laser (intervention) and no-laser groups (control). Random allocation list was generated using randomization software . Each patient could just provide an area for implant treatment.
Settings and conduct
This study was performed in Department of Maxillofacial Surgery of Islamic Azad University of Isfahan.
Immediately after tooth extraction, the implant was inserted into the the tooth socket area in terms of the standard protocol. LLLT was immediately started after surgery, and was repeated for three times per week for 2 weeks.
The operator was not blinded. All other contributors to the study were blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
Individuals referred to the Department of Oral and Maxillofacial Surgery, were treated with tooth extraction and implant placement, without inflammation or gingivitis, Healthy adults who are at least 18 years old, Sufficient bone density to receive the implant, Having at least 6 mm bucco-lingual ridge width at the site of implant placement.
Exclusion criteria
Pregnancy or lactation, using anticoagulants, systemic glucocorticoid therapies, acute oral infection, untreated or uncontrolled periodontal disease.
Intervention groups
660 nm LLLT was applied in this study along implants longitudinal axis to the member of laser group(intervention group). To implants in the no-laser group(control group), the laser did not shine.
Main outcome variables
Bone quantification at the implant site was assessed using periapical intraoral radiograph and computerized software immediately after the surgery and also by passing 4 months from that.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191019045159N1
Registration date:2019-12-04, 1398/09/13
Registration timing:retrospective
Last update:2019-12-04, 1398/09/13
Update count:0
Registration date
2019-12-04, 1398/09/13
Registrant information
Name
Alireza Sighari Deljavan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3535 4123
Email address
alireza_sigharydeljavan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-10-07, 1398/07/15
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2019-10-07, 1398/07/15
Trial completion date
2019-10-07, 1398/07/15
Scientific title
Effect of Postoperative 660 nm Low-Level Laser Therapy on the Radiographic Crestal Bone Loss of Fresh Socket Implants
Public title
Effect of Low-Level Laser Therapy on Bone Loss around Dental Implants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals referred to the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Islamic Azad University, Isfahan, Iran, were treated with tooth extraction and implant placement.
patients without inflammation or gingivitis.
Healthy adults who are at least 18 years old.
Sufficient bone density to receive the implant without the need for bone augmentation.
no history of tooth extraction within selected 6 months.
Having at least 6 mm bucco-lingual ridge width at the site of implant placement for inserting an implant at least 4 mm in diameter in ideal position.
Exclusion criteria:
pregnancy or lactation
systemic diseases affecting osseointegration
using anticoagulants
systemic glucocorticoid therapies
history of radiotherapy in craniofacial region in the last 12 months
smoking more than 10 cigarettes per day
mouth cancer
history of seizures
Acute oral infection
Untreated or uncontrolled periodontal disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Thirty patients were randomly divided into two groups: laser (intervention) and no-laser groups (control). Random allocation list was generated using randomization software (RandList version 1.2; DatIng GmbH, Tübingen, Deutschland). Each patient could just provide an area for implant treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The stages of the study were described for each patient and the volunteers who completed the study completed the written informed consent form and entered the study. We placed the laser on the patient's surgical area in control group ,but no laser emission is received to them to avoid bias during the study.
The amount of bone resorption was calculated by a radiologist using the software to identify the smallest pixel identifiable from the bone. The person who calculated the amount of bone resorption by software from the patient's graphs was blinded regarding group assignment.
The data analyzer also did not know whether the patients were in the intervention or control group and the data were given to him as groups one and two.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Isfahan
Street address
Jey st
City
Isfahan
Province
Isfehan
Postal code
5157679445
Approval date
2018-09-12, 1397/06/21
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.072
Health conditions studied
1
Description of health condition studied
Crestal Bone Loss
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Crestal Bone Loss
Timepoint
immediately after the surgery and also by passing 4 months from that.
Method of measurement
Bone quantification at the implant site was assessed using periapical intraoral radiograph and computerized software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After selection of the patients based on eligibility criteria, local anesthesia was performed by injecting 2% lidocaine (with adrenaline 1/80000). After cutting the crestal and removing the mucoperiosteal flap and extracting the tooth without trauma, preparation of bone -level implant recipient was done under cooling with physiological serum solution, in terms of the manufacturer's protocol (Dio, Seoul, Korea). For all implants, a speed of 15rpm with a torque of 35-40 Ncm was used. Diameter of the implants was chosen so that, at least 1 mm of bone remained on both buccal and palatal sides after implant placement. For vertical positioning, the implant should also be positioned in the same level of buccal bone crest. After implantation, the implant was implanted with the surrounding mucosa and the area was sutured, and the sutures were removed by passing 7 days from surgery. After the surgery, all the patients received amoxicillin (1.5 g) or clindamycin (1.8 g) daily for 3 days as well as non-steroidal anti-inflammatory drug for pain relief and mouthwash. The patients were also received advice regarding oral hygiene. No temporary dentures were placed during the 4-month follow-up.A low-level 660 nm diode laser illuminated to surrounding tissues of the implant along its longitudinal axis was applied in this study. Low-Level Laser Treatment (LLLT) was started immediately after the surgery and was repeated three times per week for 2 weeks. Total radiation dose per treatment for each implant unit was 6.26 J / cm². Output power was checked before working with the power meter.
Category
Prevention
2
Description
Control group: After selection of the patients based on eligibility criteria, local anesthesia was performed by injecting 2% lidocaine (with adrenaline 1/80000). After cutting the crestal and removing the mucoperiosteal flap and extracting the tooth without trauma, preparation of bone -level implant recipient was done under cooling with physiological serum solution, in terms of the manufacturer's protocol (Dio, Seoul, Korea). For all implants, a speed of 15rpm with a torque of 35-40 Ncm was used. Diameter of the implants was chosen so that, at least 1 mm of bone remained on both buccal and palatal sides after implant placement. For vertical positioning, the implant should also be positioned in the same level of buccal bone crest. After implantation, the implant was implanted with the surrounding mucosa and the area was sutured, and the sutures were removed by passing 7 days from surgery. After the surgery, all the patients received amoxicillin (1.5 g) or clindamycin (1.8 g) daily for 3 days as well as non-steroidal anti-inflammatory drug for pain relief and mouthwash. To implants in the control group, the laser did not shine. We placed the laser on the patient's surgical area in control group ,but no laser emission is received to them to avoid bias during the study.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and Maxillofacial Surgery Department of Islamic Azad University of Isfahan
Full name of responsible person
Alireza Sighari Deljavan
Street address
Unit 25, Kasra Apartment, Kasra Alley, Beheshti Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8184865759
Phone
+98 31 3535 4123
Email
Alireza_sigharydeljavan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hasan Momeni
Street address
Faculty of Dentistry, Islamic Azad University, Jay Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8184865759
Phone
+98 31 3535 4123
Email
Alireza_sigharydeljavan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research of Islamic Azad University of Isfahan
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Sighari Deljavan
Position
Postgraduate Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Unit 25, Kasra Apartment, Kasra Alley, Beheshti Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8184865759
Phone
+98 31 3535 4123
Email
Alireza_sigharydeljavan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Sighary Deljavan
Position
Postgraduate Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Unit 25, Kasra Apartment, Kasra Alley, Beheshti Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8184865759
Phone
+98 31 3535 4123
Email
Alireza_sigharydeljavan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Sighari Deljavan
Position
Postgraduate Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Unit 25, Kasra Apartment, Kasra Alley, Beheshti Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8184865759
Phone
+98 31 3535 4123
Email
Alireza_sigharydeljavan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after unidentifiable people
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Data will be available to researchers working in academia and in the industry as well.
Under which criteria data/document could be used
All the scientific analyzes that are required to advance science and industry are permitted on the data of this study.
From where data/document is obtainable
For any information you can send an email to this email address: Alireza_sigharydeljavan@yahoo.com
What processes are involved for a request to access data/document
For recieving these documents you can send your Individual specifications and desired request to this email address: Alireza_sigharydeljavan@yahoo.com