Comparison of the clinical outcomes of conventional periodontal flap surgery versus laser-assisted periodontal flap surgery in patients with moderate to severe chronic periodontitis: a randomized clinical trial
Objectives: To compare the clinical outcomes of conventional periodontal flap surgery versus laser-assisted periodontal flap surgery in patients with moderate to severe chronic periodontitis.
Design: A randomized clinical trial.
Setting and conduct: The eligible patients with moderate to severe chronic periodontitis who will refer to School of Dentistry during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 65 years; moderate to severe chronic periodontitis
Exclusion criteria: Pregnancy or breastfeeding; chronic disease; using tobacco; a history of gum surgery; angular bone lesions.
Intervention group: Treatment of periodontitis of one side of the mouth via open flap and removing the granulation tissue by laser with a wavelength of 2780 nm.
Control group: Treatment of periodontitis of the other side of the mouth via open flap and removing the granulation tissue by conventional surgery.
Primary outcome: (a) average changes in pocket depth 1 and 3 months after treatment with a clinical examination; (b) average changes in CAL 1 and 3 months after treatment with a clinical examination; (c) average changes of gum resorption 1 and 3 months after treatment with a clinical examination; (d) average changes in the percentage of plaque index 1 and 3 months after the clinical examination; (e) the average changes in the percentage of gum bleeding 1 and 3 months after the treatment with a clinical examination.
Randomization: Random assignment of the right and left side of the mouth to the intervention and control groups through drawing of lots.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201711129014N199
Registration date:2017-11-20, 1396/08/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-20, 1396/08/29
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
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-11-11, 1396/08/20
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the clinical outcomes of conventional periodontal flap surgery versus laser-assisted periodontal flap surgery in patients with moderate to severe chronic periodontitis: a randomized clinical trial
Public title
Comparison of the clinical outcomes of conventional periodontal flap surgery versus laser-assisted periodontal flap surgery in patients with moderate to severe chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 65 years; moderate to severe chronic periodontitis
Exclusion criteria: Pregnancy or breastfeeding; chronic disease; using tobacco; a history of gum surgery; angular bone lesions.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the right and left side of the mouth to the intervention and control groups through drawing of lots.
Blinding: Not possible.
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
Postal code
Approval date
2017-11-04, 1396/08/13
Ethics committee reference number
IR.UMSHA.REC.1396.525
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
Average changes in pocket depth
Timepoint
1 and 3 months after treatment
Method of measurement
With a clinical examination
2
Description
Average changes in changes in CAL
Timepoint
1 and 3 months after treatment
Method of measurement
With a clinical examination
3
Description
Average changes in gum resorption
Timepoint
1 and 3 months after treatment
Method of measurement
With a clinical examination
4
Description
Average changes in the percentage of plaque index
Timepoint
1 and 3 months after treatment
Method of measurement
With a clinical examination
5
Description
Average changes in the percentage of gum bleeding
Timepoint
1 and 3 months after treatment
Method of measurement
With a clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment of periodontitis of one side of the mouth via open flap and removing the granulation tissue by laser with a wavelength of 2780 nm.
Category
Treatment - Other
2
Description
Control group: Treatment of periodontitis of the other side of the mouth via open flap and removing the granulation tissue by conventional surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Dr Iman Barati
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Dentistry
Full name of responsible person
Dr Iman Barati
Position
Resident of Periodontics
Other areas of specialty/work
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
baratibros@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry
Full name of responsible person
Dr Leila Gholami
Position
Periodontics
Other areas of specialty/work
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
l.gholami@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)