Culture of human gingival fibroblasts on an autologous scaffold and evaluation of its effect on augmentation of attached gingiva in comparison with the periosteal fenestration technique in patients with inadequate attached gingiva in a pilot clinical trial
The aim of this study is to evaluate the effect of culture of human gingival fibroblasts on an autologous scaffold on attached gingival augmentation. The patients entered in this study should have at least two non-adjacent tooth with an insufficient zone of attached gingiva that required soft tissue grafting . under local anesthesia, a small biopsy 3*2 mm will be prepared from the attached gingiva of the patient. fibroblasts prepared from this biopsy will be added to PRGF prepared from the patient blood to produce a cultured gingival graft. with throwing a coin, control and interventional sides will be randomly selected . preparation of the bed in both sides is periosteal fenestration. At the test site , the tissue engineered gingival graft will be removed from the sterile package , shaped and adapted to the recipient site. A vaseline gauze in an appropriate size will be placed on the graft surface and then a foil adapted . These components will be fixed with sutures. In control side, the process is similar with interventional side but without using the graft. the results ( change in attached and keratinized gingival width and probing depth ) will be checked after 3 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108135305N2
Registration date:2013-10-14, 1392/07/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-14, 1392/07/22
Registrant information
Name
Mohammad Mohammadi
Name of organization / entity
Kerman Dental School
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 9021
Email address
m_mohammadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman Oral and Dental Diseases Research ; Vice Chancellor for Research, Kerman University of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-09-23, 1389/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Culture of human gingival fibroblasts on an autologous scaffold and evaluation of its effect on augmentation of attached gingiva in comparison with the periosteal fenestration technique in patients with inadequate attached gingiva in a pilot clinical trial
Public title
Gingival Graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: no systemic diseases that contraindicated periodontal surgery ; no medications affecting periodontal surgery ; no pregnancy or lactation ; no periodontal diseases ; no smoking ; full mouth plaque score and full mouth bleeding score < 20% at the time of the surgical procedures ; at least two non-adjacent tooth with an insufficient zone of attached gingiva that required soft tissue grafting .
exclusion criteria: full mouth plaque score and full mouth bleeding score > 20% at the time of the surgical procedures
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
4
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
a pilot study, case series
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman Medical Sciences University
Street address
Tahmasbabad Crossover, Researches Center
City
Kerman
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
کا/86/96
Health conditions studied
1
Description of health condition studied
gingival disease
ICD-10 code
B99
ICD-10 code description
Other and unspecified infectious diseases
Primary outcomes
1
Description
keratinized gingival width
Timepoint
baseline and after 3 months
Method of measurement
the distance between gingival margin and MGJ , measurment with periodontal probe
2
Description
attached gingival width
Timepoint
baseline and 3 months later
Method of measurement
the distance between MGJ to base of the sulcus, measurment with periodontal probe.
3
Description
probing depth
Timepoint
baseline an 3 months later
Method of measurement
the amount of penetration of periodontal probe into the sulcus