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Clinical and Radiographic Evaluation of the Effect of Using Photobiomodulation in Comparison with Platelet-Rich Fibrin on Dental Sockets Healing: A Single-blind Randomized Clinical Trial

Protocol summary

Study aim
Comparison of the Effect of Photobiomodulation with Platelet-Rich Fibrin on the Amount of New Bone Formation, Vertical Height and Width of the Buccolingual Alveolar Ridge, Pain Reduction, Width of Keratinized Gingiva, Bone Density
Design
Randomized, Single-Blinded Clinical Trial with Two Parallel Groups design of 36 patients. Rand Function of Excel Software used for Randomization.
Settings and conduct
In the PRF Group, 10 ml of Blood Samples are taken from Patients in the Experimental Group and Centrifuged at 3000 rpm for 10 Minutes. After Atraumatic Extraction, The Obtained PRF is Placed in the Socket and the Socket is Sutured. In the Photobiomodulation Group, On the Day after the Extraction, a Diode Laser with a Wavelength of 660 nm is used and a Diode Laser with a Wavelength of 970 nm is used for Every Other Day to at least Two Weeks. Clinical and Radiographic Parameters are evaluated by the Measuring Person in Two Different Time Periods, One at the Beginning of the Work after Tooth Extraction and the Other, 8 Weeks later. All the Procedure Are Performed in Touba Dental Clinic.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients Over 18 Years of Age with Indications for Extraction of Anterior Teeth and Premolars of the Maxilla and Mandible without the Need for Surgery; ASA I-II Patients Exclusion Criteria: Poor Oral Hygiene; Pregnant or Lactating Women; Smokers and Alcoholism; Chronic Treatment with Any Drug that Affects Bone Function
Intervention groups
In PRF Group, After Tooth Extraction, the PRF is Placed in the Socket. In the Photobiomodulation Group, On the Day after the Tooth Extraction, a Diode Laser Is Used to Socket Preservation.
Main outcome variables
Vertical Height and Width of the Buccolingual Alveolar Ridge; Soft Tissue Healing; Width of Keratinized Gingiva; pain; Bone Density; Bone Formation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230222057497N1
Registration date: 2023-05-09, 1402/02/19
Registration timing: prospective

Last update: 2023-05-09, 1402/02/19
Update count: 0
Registration date
2023-05-09, 1402/02/19
Registrant information
Name
Avideh Maboudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 3345
Email address
ftm7soleymani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-31, 1402/03/10
Expected recruitment end date
2023-09-01, 1402/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical and Radiographic Evaluation of the Effect of Using Photobiomodulation in Comparison with Platelet-Rich Fibrin on Dental Sockets Healing: A Single-blind Randomized Clinical Trial
Public title
Comparison of the Effect of Using Photobiomodulation with Platelet-Rich Fibrin on Dental Sockets Healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 Years of Age Referring to the Special Clinic of the Sari Dental Faculty who have Extensive Irreparable Caries, Failed Root Canal Therapy, Periodontal Disease, Tooth Fracture, Indications for Extraction of Anterior Teeth and Premolars (Maxilla and Mandible) Intact Surrounding Alveolar Bone (Remaining Bone at least Two-Thirds of the Root Length) Tooth Socket with Four Healthy Walls after Extraction Patients Who Willing to Participate in the Study Teeth that Do not Require Surgical Methods to Remove and Do not Require Using of Surgical Burs Patients Who have the Ability to Participate in Examinations and Follow-up ASA I-II Patinets
Exclusion criteria:
Patients with Poor Oral Hygiene Pregnant or Lactating Women or Patients Who are Planning to Get Pregnant Smokers (More than ten Cigarettes per Day) and Alcoholism Patients with Uncontrolled Systemic Disease and History of Head and Neck Radiotherapy and Weak Immune System Chronic Treatment with Any Drug that Affects Bone Function: Heparin, Cyclosporine, Bisphosphonate, Chemotherapy Drugs Presence of Periapical or Periodontal Considerable Lesions around the Corresponding Teeth and Presence of Dehiscence and Fenestration in the Buccal Bone Plate Contraindications for Tooth Extraction Allergy to Any of the Study Products A Severe Acute lnfection or Any Other Factor that Limits the Opening of the Mouth
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
‏Using block classification, the samples will be assigned to two groups: C (control group (atraumatic extraction only) and T (intervention group (platelet-rich fibrin (PRF) along with photobiomodulation))). The blocking process is done using Excel software and the samples will be placed in 9 blocks of 4 (the total sample size is 36). ‏We will have six types of blocks of 4 such as TTCC, TCTC, TCCT, CCTT, CTCT, CTTC, where T is for the intervention group and C is for the control group. Using Excel software, numbers will be randomly generated 9 times with the RANDBETWEEN command in the range of 1 to 6 and according to the production values ​​of one of the blocks (for a production number 1 CTTC block, for a production number 2 CTCT blocks and so on) Samples will be allocated. For example, four people have come to the center, two people are supposed to enter the intervention group and two people are in the control group. In the Excel software, between the number one and six, the number two is supposed to be chosen by chance, so these four people are assigned to the CTCT block in the order of reference. In fact, the first person enters the control group, the second person enters the intervention group, the third person enters the control group, and the fourth person enters the intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The Study Sequence will be hidden from the Person who Measures (Radiologist, Periodontist).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Third floor, Mazandaran University of Medical Sciences, Research and Technology Deputy Buildin, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4814969616
Approval date
2023-01-07, 1401/10/17
Ethics committee reference number
IR.MAZUMS..REC.1401.427

Health conditions studied

1

Description of health condition studied
Platelet-Rich Fibrin, Photobiomodulation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
“Vertical height” and “buccolingual” width of alveolar ridge, “Soft tissue healing”, “Keratinized gingival width”, “Pain”, “Bone density”
Timepoint
At the beginning of the study (before the start of the study) and 8 weeks after tooth extraction
Method of measurement
Periodontal Probe, Visual Analogue Scale, Cone Beam CT Scan, Inspection, Fractal Analysis

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The nurse takes 10 ml of a blood sample from the median cubital vein of each patient and puts it in a dry test tube without anticoagulant. Then, they will be centrifuged in a centrifuge machine (BioHorizon,USA) at a speed of 3000 rpm for 10 minutes. The obtained PRF will be separated using a sterile tweezer. The PRF will be placed inside the socket and sutured with a 4-0 polyglycolic acid suture with a 19 needle (Suchers-Iran) using figure 8 suturing technique
Category
Treatment - Other

2

Description
Control group: Immediately after tooth extraction, the socket is sutured with a 4-0 polyglycolic acid suture with a 19 needle (Suchers-Iran) using figure 8 suturing technique. The day after the extraction, the periodontist Uses a diode laser (Dentsply Sirona, Germany) with a wavelength of 660 nm,  power of 100 MW, and energy density of 2 j/cm2 for 10 seconds in three positions, i.e., buccally, lingually, and diagonally to the edge of the tissue. She will also perform it from the socket with the minimum possible distance to repair the soft tissue. Then, she will continuously use diode laser radiation (Dentsply Sirona, Germany) with a wavelength of 970 nm, power of 200 MW, and an energy density of 6 j/cm2 for 20 seconds to repair the hard tissue. The laser is irradiated by a low-power head (8 mm multi tip with a cross-sectional area of ​​1.5 cm2) in the buccal and lingual areas so that it covers half the length of the root each time. This protocol is repeated on the day after the extraction and then every other day for at least two weeks (1, 3, 6, 8, 10, 13, 15)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tuba clinic
Full name of responsible person
Avideh Maboudi
Street address
Tuba clinic, Dr. Beheshti Blvd., Khazar Square
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4014
Email
avideh48188@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Avideh maboudi
Street address
Tuba clinic, Dr. Beheshti Blvd., Khazar Square
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4014
Email
avideh48188@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
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
Mazandaran University of Medical Sciences
Full name of responsible person
Avideh Maboudi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Sadaf Complex, Narenj Alley, 15 Khordad Ave
City
Sari
Province
Mazandaran
Postal code
4818865454
Phone
+98 11 3326 3345
Email
avideh48188@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Avideh Maboudi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Sadaf Complex, Narenj Alley, 15 Khordad Ave
City
Sari
Province
Mazandaran
Postal code
4818865454
Phone
+98 11 3326 3345
Email
avideh48188@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Avideh Maboudi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Sadaf Complex, Narenj Alley, 15 Khordad Ave
City
Sari
Province
Mazandaran
Postal code
4818865454
Phone
+98 11 3326 3345
Email
avideh48188@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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Vertical Height and Width of the Buccolingual Alveolar Ridge; Soft Tissue Healing; Width of Keratinized Gingiva; pain; Bone Density
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The request should be sent to the responsible person after consultation with the research team, the data will be provided to the requesting person and it is necessary to give reference to the data owners in the articles or wherever the data is going to be used.
From where data/document is obtainable
Avideh Maboudi Sadaf Complex, Narenj Alley, 15 Khordad Ave, Postal code 4818865454 989111531637 981133263345 avideh48188@yahoo.com
What processes are involved for a request to access data/document
Send the reason for the request to avideh48188@yahoo.com email address
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