Protocol summary

Study aim
We intend to conduct this study with the laser treatment model of the RWTH University of Aachen, Germany. If we get favorable results, we will propose a more effective solution than conventional non-surgical treatment methods (SRP and antibiotic therapy).
Design
Randomized, parallel-group trial with blinded outcome assessment. Randomization for choosing left or right was conducted by tossing a coin.
Settings and conduct
Patients referring to the Anzali campus dental school clinic and a specialized private practice in Rasht city in 1401-1402 are studied depending on the number calculated in the statistical survey. The person responsible for measuring clinical parameters and patients will not be aware of the laser-treated side.
Participants/Inclusion and exclusion criteria
1. Not receiving any periodontal treatment in the last 12 months 2. Not taking any type of antibiotic, anti-inflammatory, or oral contraceptive drugs during the last 3 months 3. Absence of any systemic disease that affects the periodontal treatment process such as uncontrolled diabetes 4. Absence of pregnancy 5. Not using any type of tobacco or drug addiction 6. No need for antibiotic prophylaxis 7. Having at least 1 point with a probe depth of more than 3 mm in each studied part
Intervention groups
The number of 44 oral segments (first premolar, second premolar, and molar teeth of each quadrant) in 12 patients are equally and randomly placed in two treatment groups: Scaling & Root Planing (SRP) and Scaling & Root Planing + Laser (SRP+L).
Main outcome variables
Diode laser with wavelengths between 655 and 980 nm can accelerate wound healing and increase angiogenesis and growth factor release. If the positive effect of laser in improving periodontal parameters is determined, this method can be used as a routine method in non-surgical treatments.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221210056769N1
Registration date: 2022-12-13, 1401/09/22
Registration timing: prospective

Last update: 2022-12-13, 1401/09/22
Update count: 0
Registration date
2022-12-13, 1401/09/22
Registrant information
Name
Seyed Ali Seyed-Monir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3372 1607
Email address
mihandoust.sanaz3@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of 940-nm Diode Laser Effectiveness on Pocket Depth, Clinical Attachment Level and Bleeding on Probing in Chronic Periodontitis
Public title
The Effect of 940-nm Diode on Periodontal Conditions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients receiving no periodontal treatments during the last 12 months No antibiotic consumption during the last 3 months Absence of any systematic disease (i.e. diabetes) affecting the process of periodontal treatment No anti-inflammatory drug consumption during the last 3 months No pregnancy No oral contraceptive pills consumption No smoking or drug addiction No need for antibiotic prophylaxis
Exclusion criteria:
Discontinuing the treatment procedure by the patient Becoming affected by a disease that requires medical therapy during the investigation period
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 12
More than 1 sample in each individual
Number of samples in each individual: 4
The number of 44 oral segments (first premolar, second premolar, and molar teeth of each quadrant) in 12 patients were equally and randomly placed in two treatment groups: Scaling & Root Planing (SRP) and Scaling & Root Planing + Laser (SRP+L).
Randomization (investigator's opinion)
Randomized
Randomization description
In the first session, supragingival scaling of the whole mouth and hygiene education is performed, and then clinical parameters including pocket depth (PD), clinical attachment loss (CAL), and bleeding on probing (BOP) are measured in 6 points of each tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual) and recorded in the corresponding form. It should be noted that the accuracy of the examiner's assessment will be checked and confirmed in several test sessions and cases under the supervision of a periodontist. Then, subgingival scaling and root planing (SRP) is performed under local anesthesia by a periodontist with a valid laser fellowship. Subsequently, one of the two left or right sides is chosen randomly by tossing a coin for the adjunctive laser treatment, and by the same periodontist undergoes laser therapy with the protocol approved by the Laser Center of RWTH University of Aachen, Germany. On the SRP side, the tip of the laser fiber is moved without being activated, similar to the method performed on the SRP+L side, so the patient does not know which side has undergone laser therapy. A week later, laser therapy is repeated without performing SRP according to the above method. It should be noted that the person responsible for measuring clinical parameters will not be aware of the laser-treated side.
Blinding (investigator's opinion)
Double blinded
Blinding description
On the SRP side, the tip of the laser fiber is moved without being activated, similar to the method performed on the SRP+L side, so the patient does not know which side has undergone laser therapy. A week later, laser therapy is repeated without performing SRP according to the above method. It should be noted that the person responsible for measuring clinical parameters will not be aware of the laser-treated side.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Guilan University of Medical Sciences
Street address
Dentistry Faculty, Guilan University of Medical Sciences, Fuman-Saravan Road
City
Rasht
Province
Guilan
Postal code
4194173774
Approval date
2017-12-16, 1396/09/25
Ethics committee reference number
IR.GUMS.REC.1396.383

Health conditions studied

1

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

Primary outcomes

1

Description
Comparative assessment of periodontal pocket depth after treatment in the case and control groups
Timepoint
3 months
Method of measurement
Using a scaled periodontal probe, the distance between the gingival wall and the tooth surface from the gingival margin to the uppermost part of the junctional epithelium is measured and recorded.

2

Description
Comparative assessment of clinical attachment loss (CAL) after treatment in the case and control groups
Timepoint
3 months
Method of measurement
Using a scaled periodontal probe, the distance between the border of the enamel and cementum (Cemento-Enamel Junction) to the depth of the pocket is measured and recorded.

3

Description
Comparative assessment of bleeding on probing (BOP) after treatment in the case and control groups
Timepoint
3 months
Method of measurement
Checking the presence or absence of blood leakage 30 seconds after probing the periodontal pocket

Secondary outcomes

empty

Intervention groups

1

Description
Control group: scaling and root planing (SRP) of the selected teeth
Category
Treatment - Devices

2

Description
Category
empty

3

Description
Intervention group: 980nm diode laser therapy of the selected teeth following the scaling and root planing (SRP)
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Guilan university of medical sciences - Anzali international campus
Full name of responsible person
Dr. Seyed Ebrahim Seyed-Monir
Street address
Gilan University of Medical Sciences International Campus Faculty, 30 meters Blvd.., Bandar Anzali
City
Anzali
Province
Guilan
Postal code
43146-37758
Phone
+98 13 4455 3185
Fax
Email
ib@gums.ac.ir

2

Recruitment center
Name of recruitment center
Specialized dental office
Full name of responsible person
Dr. Seyed Ebrahim Seyed-Monir
Street address
specialized dental office of Dr. Seyed ebrahim Seyed-Monir, 3rd floor, Naderi Building, Saadi St., Gulsar
City
Rasht
Province
Guilan
Postal code
41356-33366
Phone
+98 13 3312 8404
Email
seyedmonir.ali13@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ms. Amani
Street address
Gilan University of Medical Sciences International Campus Faculty, 30 meters Blvd., Bandar Anzali
City
Bandar Anzali
Province
Guilan
Postal code
43146-37758
Phone
+98 13 4455 3185
Email
ib@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal by the researcher
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Seyed Ebrahim Seyed-Monir
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Periodontist
Street address
Guilan University of Medical Sciences International Campus Faculty, 30 meters Blvd., Bandar Anzali
City
Bandar Anzali
Province
Guilan
Postal code
43146-37758
Phone
+98 13 4455 3185
Email
seyedmonir.ali13@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Seyed Ebrahim Seyed-Monir
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Guilan University of Medical Sciences International Campus Faculty, 30 meters Blvd, Bandar Anzali
City
Bandar Anzali
Province
Guilan
Postal code
43146-37758
Phone
+98 13 4455 3185
Email
seyedmonir.ali13@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Seyed Ebrahim Seyed-Monir
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Guilan University of Medical Sciences International Campus Faculty, 30 meters Blvd., Bandar Anzali
City
Bandar Anzali
Province
Guilan
Postal code
43146-37758
Phone
+98 13 4455 3185
Email
seyedmonir.ali13@gmail.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
Not applicable
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
Loading...