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Effect of adjunctive use of Nd:YAG laser in periodontal surgeries in patients with generalized moderate chronic periodontitis

Protocol summary

Study aim
Effect of adjunctive use of Nd:YAG laser in periodontal surgeries in patients with generalized moderate chronic periodontitis
Design
Clinical trial with control group, with parallel groups, One-way blind, randomized, each group 17 patients
Settings and conduct
The study will be performed in the Department of Oral and Maxillofacial Diseases of Tabriz Dental School. The outcome assessor is unaware of the type of treatment.The OFD quadrant procedure will be performed first. Two weeks later, the irradiating Nd: YAG laser will performed to the inner layer of the flap.In the experimental group, the controlled OFD quadrant procedure will be performed first. Two weeks later, will be performed irradiating Nd: YAG laser to the inner layer of the flap. In the control group, all the steps performed for the experimental group will be repeated, except, laser radiation is not performed. Finally, determining and comparing the distance between the joint of cement and enamel to the depth of the envelope, the depth of probing, bleeding during probing will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Generalized moderate chronic periodontitis,Willingness to participate in the study.Age between 20-55 Inclusion criteria:Having any systemic diseases and debilitating diseases that can affect a person's oral health, Any surgical and non-surgical periodontal treatments and antibiotic therapy performed during the last 6 months,Pregnancy,Alcohol consumption,Tobacco use during the last three months,Taking anti-inflammatory drugs and antibiotics for the past three months
Intervention groups
The two assessment groups will include the control group as open flap debridment (OFD) and the test group as open flap debridment (OFD) with Nd: YAG laser
Main outcome variables
Evaluation and comparison of the cilinical attachment level,probing depth,bleeding on probing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200727048216N1
Registration date: 2020-08-19, 1399/05/29
Registration timing: prospective

Last update: 2020-08-19, 1399/05/29
Update count: 0
Registration date
2020-08-19, 1399/05/29
Registrant information
Name
Hosein Eslami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5968
Email address
eslamihosein56@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-21, 1399/05/31
Expected recruitment end date
2020-11-19, 1399/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of adjunctive use of Nd:YAG laser in periodontal surgeries in patients with generalized moderate chronic periodontitis
Public title
Effect of adjunctive use of Nd:YAG laser in periodontal surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Generalized moderate chronic periodontitis Willingness to participate in the study Age between 20-55
Exclusion criteria:
Having any systemic diseases and debilitating diseases that can affect a person's oral health Any surgical and non-surgical periodontal treatments and antibiotic therapy performed during the last 6 months Pregnancy alcohol consumption Tobacco use during the last three months Taking anti-inflammatory drugs and antibiotics for the past three months
Age
From 20 years old to 55 years old
Gender
Both
Phase
1
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 17
Randomization (investigator's opinion)
Randomized
Randomization description
Prior to surgery, randomly selected quadrants (by taping or scribbling a coin) will be assigned to the control and experimental groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Surgery will be performed by a periodontist and laser therapy will be performed by an oral medicine specialist. To measure blindness, measurements will be performed by a student under the supervision of a periodontist who is unaware of the treatment performed for the quadrants.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Tanriz University of Medical Sciences
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-06-07, 1399/03/18
Ethics committee reference number
IR.TBZMED.REC.1399.229

Health conditions studied

1

Description of health condition studied
Generalized moderate chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis

Primary outcomes

1

Description
Clinical attachment loss
Timepoint
Start of study, 1 and 3 months after surgery
Method of measurement
Williams probes

2

Description
Probing depth
Timepoint
Start of study, 1 and 3 months after surgery
Method of measurement
Williams probes

3

Description
Bleeding on probing
Timepoint
Start of study, 1 and 3 months after surgery
Method of measurement
Williams probes

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the experimental group, the controlled OFD quadrant process will be performed first. Two weeks later, Nd: YAG laser radiation will be applied to the inner layer of the flap. The Nd: YAG laser with a wavelength of 1064 nm, an average efficiency of 4 w, energy per pulse of 80 mj, a diameter of 600 µm and a disposable fiber optic tip will be used to deliver energy to the area. The 4w medium-efficiency laser is placed in the pulse depth of the envelope, avoiding direct contact with the tooth or bone, by placing the fiber-optic tip in the pulse depth. The patient will receive routine antibiotic treatments. Finally, the distance between the cement and the enamel to the depth of the envelope, the depth of the probing, and the bleeding during the probing will be measured and compared.
Category
Treatment - Devices

2

Description
Control group: The controlled OFD quadrant procedure will be performed first and the patient will receive routine antibiotic treatments after surgery. Finally, determining and comparing the distance between the joint of cement and enamel to the depth of the envelope, the depth of probing, bleeding during probing will be measured.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Dental School
Full name of responsible person
Hosein Eslami
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5969
Email
eslamihosein56@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5969
Email
samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Hosein Eslami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5969
Email
eslamihosein56@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hosein Eslami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5969
Email
eslamihosin56@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hosein Eslami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5969
Email
eslamihosein56@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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