1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effect of scaling and root planning through conventional method versus using a laser on the treatment of chronic periodontitis: a single-blind randomized clinical trial

Protocol summary

Study aim
To assess the effect of scaling and root planning through conventional method versus using a laser on the treatment of chronic periodontitis
Design
This is a single-blind randomized clinical trial, phase II, in which 16 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with chronic periodontitis referring to the School of Dentistry in Hamadan city during the study period will be enrolled in the trial and the right or left side of the patient will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be single-blinded so that the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 20 to 65 years, Moderate to severe generalized chronic periodontitis, Envelope depth 4 to 7 mm without destruction of angular bone, Exclusion criteria: Pregnancy or breastfeeding, Any systemic disease, Using tobacco
Intervention groups
Intervention group: Scaling and root planning using a laser Er, Cr: YSGG, with a head of RFTP5, 1.5 W, 30 Hz, with an angle of less than 15 and parallel to the long axis of the tooth Control group: Scaling and leveling the root surface through the conventional method using a piezoelectric scaling machine with a sharp pen
Main outcome variables
Primary outcome: Probing Depth (PD), Clinical Attachment Level (CAL), Gingival recession (GR), Plaque Index (PI), Bleeding on Probing (BOP)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N372
Registration date: 2020-12-06, 1399/09/16
Registration timing: prospective

Last update: 2020-12-06, 1399/09/16
Update count: 0
Registration date
2020-12-06, 1399/09/16
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of scaling and root planning through conventional method versus using a laser on the treatment of chronic periodontitis: a single-blind randomized clinical trial
Public title
Comparison of the effect of scaling and root planning through conventional method versus using a laser on the treatment of chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20 to 65 years, Moderate to severe generalized chronic periodontitis, Envelope depth 4 to 7 mm without destruction of angular bone,
Exclusion criteria:
Pregnancy or breastfeeding, Any systemic disease, Using tobacco
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 16
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the right and left sides of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "right" on one sheet and "left" on another. Then, by referring to every patient, one of the sheets will be randomly taken. According to whether the sheet is taken right or left is assigned to the intervention group and the other side to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as single-blind
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-10-24, 1399/08/03
Ethics committee reference number
IR.UMSHA.REC.1399.628

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
Probing Depth (PD)
Timepoint
Before the intervention and 1 and 3 weeks after that
Method of measurement
By physical examination

2

Description
Clinical Attachment Level (CAL)
Timepoint
Before the intervention and 1 and 3 weeks after that
Method of measurement
By physical examination

3

Description
Gingival recession (GR)
Timepoint
Before the intervention and 1 and 3 weeks after that
Method of measurement
By physical examination

4

Description
Plaque Index (PI)
Timepoint
Before the intervention and 1 and 3 weeks after that
Method of measurement
By physical examination

5

Description
Bleeding on Probing (BOP)
Timepoint
Before the intervention and 1 and 3 weeks after that
Method of measurement
By physical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Scaling and root planning using a laser Er, Cr: YSGG, with a head of RFTP5, 1.5 W, 30 Hz, with an angle of less than 15 and parallel to the long axis of the tooth
Category
Treatment - Other

2

Description
Control group: Scaling and leveling the root surface through the conventional method using a piezoelectric scaling machine with a sharp pen
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Dentistry in Hamadan city
Full name of responsible person
Sahar Hemmatian
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sahar.hemmatian@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Sahar Hemmatian
Position
Dentistry Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sahar.hemmatian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Janet Moradi
Position
Periodontologist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Janet_haghgoo@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

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
Loading...