All patients will receive oral hygiene instructions and initial periodontal therapy to establish optimal plaque control and gingival health. Impression is taken from palatal region to prepare a surgical stent to protect the donor area. Surgical procedures will be carried out by one of the authors not aware of the study groups, according to Sullivan and Atkins technique. A 9*14 mm template made of aluminium foil is used to harvest the standardized graft. A rectangular shape incision with thickness of 1-1.5 mm is prepared in the area between distal finish line of the maxillary canine and distal of the first molar tooth in both groups. Subsequent to graft harvesting, the study group will receive laser irradiation of 940nm GaAlAs 5 J/cm2 immediately after surgery and every other day within the following ten days. Postoperative instructions will be provided to each individual. Epithelialization, Remaining Wound Area(RWA) & color match will be evaluated on the day of surgery and on the 7th , 14th, 28th, 60th days after surgery. Pain and secondary bleeding will be measured in the first ten days after surgery through the questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017092036203N2
Registration date:2017-11-01, 1396/08/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-01, 1396/08/10
Registrant information
Name
Hoori Asl Roosta
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8849 2345
Email address
h-aslroosta@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
no external funding
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Ga Al As 940nm low-level laser therapy on the healing of human palatal mocusa after free gingival graft surgery:a clinical trial study
Public title
The effect of laser therapy on the healing of human palatal wound after free gingival graft surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patents aged between 20 and 70 years old, systemically healthy, keratinized tissue width<1mm , Full Mouth Plaque Score (FMPS)<20%, Full Mouth Bleeding Score (FMBS)<20%, absence of pathological or morphological alterations in the palatal region (donor site).
Exclusion criteria: presence of gag reflex, smoking, presence of proximal bone loss, loss of sensation in palatal mucosa, tooth mobility and/or occlusal trauma in corresponding area, excessive forces (e.g., mechanical forces from orthodontics and traumatic occlusions), systematic diseases that would contraindicate periodontal surgery or interfere with tissue healing such as diabetes, chronic high dose steroid therapy, history of radiation or immuno-suppressive therapy, pregnancy, lactation, gastro-intestinal problems, hyper sensitivity to impression materials, history of drug therapies that are known to interfere with healing or cause gingival enlargement, and patients not complying with postoperative protocols and/or attending their visits irregularly.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Dentistry Faculty of Tehran University of Medical Sciences
Street address
Dentistry Faculty of Tehran University of Medical Sciences, North Karegar St, Tehran, Iran
City
Tehran
Postal code
Approval date
2017-09-10, 1396/06/19
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1396.3394
Health conditions studied
1
Description of health condition studied
Palatal wound after free gingival graft surgery
ICD-10 code
K13.7
ICD-10 code description
Other and unspecified lesions of oral mucosa
Primary outcomes
1
Description
Remaining Wound Area
Timepoint
On the day of surgery and on the 7th , 14th, 28th, 60th days after surgery
Method of measurement
Image J software (mm2)
Secondary outcomes
1
Description
Pain
Timepoint
The first 10 days after surgery
Method of measurement
Questionaire (VAS)
2
Description
Epithelialization
Timepoint
On the 7th , 14th, 28th, 60th days after surgery
Method of measurement
By means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface (total, partial or none)
3
Description
Secondary bleeding
Timepoint
The first 10 days after surgery
Method of measurement
Questionaire
4
Description
Colour Match (brightness parameters)
Timepoint
On the 7th , 14th, 28th, 60th days after surgery
Method of measurement
Adobe photoshop software
Intervention groups
1
Description
The patients allocated for the test group will receive the
following protocol for laser application: A GaAlAs laser will be used for irradiation at a wavelength of 940 nm, an intensity that had been previously calibrated by the manufacturer.(Ezlase; Biolase Technology Inc., Irvine,CA, USA). The wounds of each experimental group receive laser stimulation at doses of 5J/cm2. The power output is maintained at a constant 0.21 W in the continuous-wave (cw) mode; The spot size is 1.26 cm2, the total energy dose per session is 6.3 J, and powerdensity is 0.16 W/cm2. Laser energy will be applied via a 400 micron optical fiber. The optical fiber is positioned at a
distance of approximately 5 mm proximal to the wound,
and the irradiation time is 30 s. The experimental
groups will receive their first dose of irradiation immediately after surgery and within ten days, one day apart following the surgery for a total of 5 sessions.
Category
Rehabilitation
2
Description
The patients allocated
to the control group will receive sham irradiation. For
this, rubber protection is placed at the tip of the
laser device, which don't allow the light to reach the
tissue. The applications will be performed by a different
operator from the one who measure the study
parameters.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry Faculty of Tehran University of Medical Sciences
Full name of responsible person
Ghazal Morshedzade Tehrani
Street address
Department of Periodontology, Thired floor, Dentistry Faculty of Tehran University of Medical Sciences, North Karegar St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Private
Full name of responsible person
Ghazal Morshedzade Tehrani
Street address
Dentistry Faculty of Tehran University of Medical Sciences, North Karegar St, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Private
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
Dentistry Faculty of Tehran University of Medical Sciences
Full name of responsible person
Ghazal Morshedzade Tehrani
Position
dentistry student
Other areas of specialty/work
Street address
Dentistry faculty of Tehran University of Medical Sciences, North Karegar St, Tehran
City
Tehran
Postal code
Phone
+98 21 8888 3575
Fax
Email
ghzlmt@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dentistry Faculty of Tehran University of Medical Sciences
Full name of responsible person
Dr. Hoori Asl Roosta
Position
Periodontologist- Assistant Professor
Other areas of specialty/work
Street address
Department of Periodontology, Third floor, Dentistry Faculty of Tehran University of Medical Sciences, North Karegar St, Tehran
City
Tehran
Postal code
Phone
+98 912 547 0342
Fax
Email
h-aslroosta@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dentistry Faculty of Tehran University of Medical Sciences
Full name of responsible person
Ghazal Morshedzade Tehrani
Position
Dentistry student
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 8888 3575
Fax
Email
ghzlmt@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)