Objective: The purpose of this study is to compare the effect of allograft to free gingival graft in increasing the attached gingiva width. Design: Thirty patients, with attached gingiva ≤1 mm on the facial aspect of teeth demonstrating a tendency of progressive marginal tissue recession, will randomly be assigned to either test or control treatment using the SPSS software. Setting and conduct: fifteen patients will receive allograft/ CenoDerm (test) and 15 patients will receive an free gingival graft (control). Participants: Patients with utmost 1 mm attached gingiva will be included and patients who fail to attend the recall visits will be excluded from the study. Clinical variables including plaque index (PI), gingival index (GI), probing depth (PD), attached tissue width (AT), and gingival recession (GR) will be recorded immediately before surgery and at the 3-month postoperative visit. Patients will be seen at 2 and 12 weeks to monitor wound healing and oral hygiene performance (PI and GI). Main outcome: Graft width will be measured, in corono-apical direction, on individually involved teeth during the surgery and 3 months later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051222249N1
Registration date:2015-06-13, 1394/03/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-13, 1394/03/23
Registrant information
Name
Kimia Najafi Khotbesara
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
knajafi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
institution
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of allograft in gingival augmentation compared to free gingival graft in patients with deficient attached gingiva
Public title
The effect of synthetic material in gingival reconstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients referred to Qazvin faculty of dentistry in 2014, who need a gingival augmentation due to gingival diseases, trauma or anatomic variations. All the participants should: 1) Practice adequate oral hygiene procedures regularly. 2) Have at least one teeth with gingival height <= 1 mm in need of gingival augmentation. 3) Have a probing depth <=3 mm in aforesaid tooth. 4) Not have any systemic diseases. 5) Not be smoker. Exclusion criteria: Failure to attend the recall visits.
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:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Each patient will receive a code and will randomly be assigned to either test or control group using the SPSS software.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences.
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
59811-34197
Approval date
2015-03-16, 1393/12/25
Ethics committee reference number
28/20/10038
Health conditions studied
1
Description of health condition studied
inadequate attached gingiva
ICD-10 code
K06.9
ICD-10 code description
Disorder of gingiva and edentulous alveolar ridge, unspecified
Primary outcomes
1
Description
attached gingiva width
Timepoint
baseline, 14 days post operation, 12 weeks post operation
Method of measurement
periodontal probe
Secondary outcomes
1
Description
inflammation, periodontal pocket
Timepoint
baseline, 12 weeks post operation
Method of measurement
gingival index, probing depth
Intervention groups
1
Description
Control: The Free Gingival Graft (FGG) is a surgical procedure frequently used in periodontics to increase the amount of keratinized tissue surrounding a tooth or a dental implant. The major limitation to the use of the FGG technique is the need for a donor site. Amongst others are anatomic limitations, color and texture mismatch with surrounding tissue that encouraged researchers to find proper alternatives for this technique.
Category
Treatment - Surgery
2
Description
Intervention: ADMs are soft tissue matrix grafts created by a process that results in decellularization but leaves the extracellular matrix intact. This matrix provides a scaffold upon and within which the patient’s own cells can repopulate and revascularize the implanted tissue. Its utility has been demonstrated in various reconstructive techniques, such as gingival augmentation, root coverage, GBR, GTR.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontics department, Qazvin University of Medical Sciences, Qazvin, Iran.
Full name of responsible person
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin university of medical sciences.
Full name of responsible person
Dr. Taghi Naserpour Farivar,
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran
City
Qazvin
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, Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Kimia Najafi
Position
periodontics resident
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
knajafi@qums.ac.irkimia_najafi@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences, Qazvin, Iran
Full name of responsible person
Dr. Kimia Najafi
Position
dentistry medical doctorate
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
knajafi@qums.ac.irkimia_najafi@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Kimia Najafi
Position
Other areas of specialty/work
Street address
Qazvin University of Medical sciences, Bahonar Blvd, Qazvin.
City
Postal code
Phone
00
Fax
Email
Knajafi@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)