objectives: to evaluate the effect of application of the biologic dressing on donor palatal wound healing and pain level.
design: 24 consecutive patients who referred to the periodontics department of dental school (TUMS) will be allocated into test and control groups.by closed envelope tech.
setting and conduct: in both groups free gingival graft surgeries have been conducted., in test group after graft harvesting, the palatal donor site is covered by biologic dressing and the dressing will be sutured. In the control group, the palatal donor site will be sutured and left uncovered to heal.
participants: healthy subject who needs gingival augmentation by free gingival graft technique in any parts of the gingiva will be included. patients with systemic diseases interfered with healing are excluded.
main out comes: the following parameters will be assessed in 7,14 and 21 days after surgery.
parameters:
1- pain scores by visual analog scale
2- number of medication taken for pain relief in first week after surgery.
3- healing rate of donor site: photographs is taken and healing process will be analysed according to color match, tissue texture and contour.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021321069N1
Registration date:2016-06-13, 1395/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-13, 1395/03/24
Registrant information
Name
zeinab kadkhoda
Name of organization / entity
Tehran university of medical sciences,faculty of dentistry.
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5801
Email address
zkadkhoda@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-12-30, 1395/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of biologic dressing on the wound healing of the palatal donor site in free gingival graft technique
Public title
effect of biologic dressing on the palatal wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
healthy subject who needs gingival augmentation by free gingival graft technique in any parts of the gingiva will be included.
exclusion criteria:
patients with non controlled diabetes;patients with immune deficiency diseases or who received immunosuppressive medications; smokers; pregnant and /or lactating women
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomization by closed envelope technique
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Tehran University of Medical Science
Street address
central building of Tehran University of Medical Science, ghods Ave, keshavarz Blvd
City
tehran
Postal code
Approval date
2016-04-11, 1395/01/23
Ethics committee reference number
IR.TUMS.REC.1395.2375
Health conditions studied
1
Description of health condition studied
palatal wound healing following free gingival graft surgeries
ICD-10 code
k06.9
ICD-10 code description
Disorder of gingiva and edentulous alveolar ridge, unspecified
Primary outcomes
1
Description
severity of pain after harvesting graft from palatal area
Timepoint
7,14 and 21 days after surgery
Method of measurement
VAS ( Visual Analogue Scale) 0= no pain, 10= the most sever pain had been experienced
Secondary outcomes
1
Description
healing rate of palatal donor area
Timepoint
7,14 and 21 days after syrgery
Method of measurement
evaluation of photographies by 2 investigators
Intervention groups
1
Description
In test group after controlling the bleeding with a wet gauze , the biologic dressing is placed on the donor site ad is sutured to the adjacent area
Category
Treatment - Surgery
2
Description
In control participants: after harvesting the tissue from the palate, gauze is kept in place to stop
Bleeding and the wound will be sutured.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
periodontics department of dental school, tehran university of medical science
Full name of responsible person
zeinab kadkhoda
Street address
north karegar Ave,periodontics department of dental school, tehran university of medical science
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research, Tehran University of Medical Science
Full name of responsible person
Dr. maasod yunesian
Street address
keshavarz Blvd, ghods Ave, tehran uviversity of medical science building
City
tehran
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, Tehran University of Medical Science
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
periodontics department of dental school, Tehran University of Medical Science
Full name of responsible person
solmaz akbari
Position
assistant professor
Other areas of specialty/work
Street address
periodontics department of dental school, Tehran University of Medical Science, north karegar Ave
City
tehran
Postal code
Phone
+98 21 8824 9184
Fax
Email
soolmaz.akbari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
periodontics department dental school, Tehran University of Medical Science
Full name of responsible person
Dr zeinab kadkhoda
Position
associete professor
Other areas of specialty/work
Street address
north karegar ave, periodontics department dental school,Tehran University of Medical Science
City
tehran
Postal code
Phone
002177665542
Fax
Email
zkadkhoda@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
periodontics department of dental school, Tehran University of Medical Science
Full name of responsible person
Dr, solmaz akbari
Position
assisstant professor
Other areas of specialty/work
Street address
periodontics department of dental school, Tehran University of Medical Science, north karegar Ave
City
tehran
Postal code
Phone
+98 21 8824 9184
Fax
Email
soolmaz.akbari@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)