Comparison of the root coverage with sub-epithelial connective tissue graft with and without root conditioning with laser in patients with gingival recession defect: a randomized clinical trial
Objectives: To compare the root coverage with sub-epithelial connective tissue graft with and without root conditioning with laser in patients with gingival recession defect.
Design: A randomized clinical trial.
Setting and conduct: The eligible patients with gingival recession defect 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; good oral hygiene (plaque index less than 30%); presence of at least 3 mm keratinized gingiva; class I and II gingival erosion defect based on Miller classification; immobility, lack of trauma due to occlusion.
Exclusion criteria: Coagulopathy disorders; using alcohol, tobacco, and opioid.
Intervention group: Routine treatment plus laser beam once at a distance of 1 to 2 mm from the surface of the root with a wavelength of 2780 nm, the power of 0.75 W, pulse duration of 140 µs, repetition rate of 20 Hz, using 90% water and 40% air through the tip MZ6 model with diameter of 600 mm and length of 6 mm.
Control group: Just routine treatment.
Primary outcome: Assessing percent coverage of gingival recession 2 weeks and 1 month after treatment with clinical examination.
Randomization: Random assignment of teeth on the right and left side of patients to the intervention and control through drawing of lots.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201705309014N167
Registration date:2017-06-01, 1396/03/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-01, 1396/03/11
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
2017-05-22, 1396/03/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the root coverage with sub-epithelial connective tissue graft with and without root conditioning with laser in patients with gingival recession defect: a randomized clinical trial
Public title
Using connective tissue graft for root coverage using root conditioning with laser in comparison with root conditioning without laser
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 65 years; good oral hygiene (plaque index less than 30%); presence of at least 3 mm keratinized gingiva; class I and II gingival recession defect based on Miller classification; immobility, lack of trauma due to occlusion.
Exclusion criteria: Coagulopathy disorders; using alcohol, tobacco, and opioid.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
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 teeth on the right and left side of patients to the intervention and control 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 the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2017-05-13, 1396/02/23
Ethics committee reference number
IR.UMSHA.REC.1396.115
Health conditions studied
1
Description of health condition studied
Gingival recession defect
ICD-10 code
K06.0
ICD-10 code description
Gingival recession
Primary outcomes
1
Description
percent coverage of gingival recession
Timepoint
2 weeks and 1 month after treatment
Method of measurement
with clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus laser beam once at a distance of 1 to 2 mm from the surface of the root with a wavelength of 2780 nm, the power of 0.75 W, pulse duration of 140 µs, repetition rate of 20 Hz, using 90% water and 40% air through the tip MZ6 model with diameter of 600 mm and length of 6 mm.
Category
Treatment - Other
2
Description
Control group: Just routine treatment.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Dr Amirarsalan Hooshyarfard
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 Amirarsalan Hooshyarfard
Position
Resident of Dentistry
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
dr.a.hooshyarfard@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry
Full name of responsible person
Dr Amirarsalan Hooshyarfard
Position
Resident of Dentistry
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
dr.a.hooshyarfard@gmail.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
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)