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The effect on the width of keratinized gingiva Mucograft prototype in comparison with the free gingival graft

Protocol summary

Summary
This prospective split-mouth will be compared the use of a collagen matrix (mucograft) to an autogenous gingival graft (FGG) in the ability to increase the zone of keratinized attached gingiva. 12 patients with inadequate amounts of keratinized attached gingiva bilaterally in the posterior mandible will be enrolled using a split-mouth design. The maintenance of periodontal health and the patient morbidity will be assessed pre-operatively at 1, 3 and 6 months. Clinical variables including plaque index (PI), gingival index (GI), probing depth (PD), attached tissue width (AT), and clinical attachment level (CAL) will be recorded immediately before surgery and at 1, 3 and 6 months postoperative visit. Patients will be seen at 2, 4, 6, 8, and 12 weeks to monitor wound healing and oral hygiene performance (PI and GI). Graft width will be also measured, in corono-apical direction, on individually involved teeth during the surgery

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013052813501N1
Registration date: 2014-12-16, 1393/09/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-16, 1393/09/25
Registrant information
Name
Hadi Zare
Name of organization / entity
Faculty Of Dentistry, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5801
Email address
h-zare@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Dentistry, Tehran University of Medical Sciences and Research Funding
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect on the width of keratinized gingiva Mucograft prototype in comparison with the free gingival graft
Public title
The effect of gingival graft by mucograft and autologous tissue graft that harvested from palate in the gingival tissue created in the same person
Purpose
Treatment
Inclusion/Exclusion criteria
Patient inclusion criteria were ; the patients older than 18 years and systemic and periodontal patients healthy ; patients with at least 2 region (Split Mouth) gingival grafts are needed. Exclusion criteria for patients from the study; Patients with systemic problems (diabetes, Immunocompromised patients, patients with chronic diseases such as hepatitis, etc.) ; Patients who consume more than 10 cigarettes per day ; patients with plaque index more than 15% ; patients who are allergic to collagen are determined
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 12
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
This study will be held as a split mouth study which both surgical methods will be introduced simultaneously on one patient.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Enghelab square
City
Tehran
Postal code
Approval date
2012-06-30, 1391/04/10
Ethics committee reference number
91-04-10-18791-78324

Health conditions studied

1

Description of health condition studied
gingival recession and inadequate amounts of keratinized attached gingiva
ICD-10 code
K06.0
ICD-10 code description
Gingival recession

Primary outcomes

1

Description
keratinized tissue width
Timepoint
pre-operatively and 1, 3 and 6 months later intervention
Method of measurement
will be measured by UNC-15 probe

2

Description
Pain reduction by new technique
Timepoint
first , 3th , 5th , 7th after intervention
Method of measurement
according to visual analogue scale

Secondary outcomes

1

Description
surgery time reduction by new material
Timepoint
From the beginning to the end of surgery
Method of measurement
According to the minutes of by the stopwatch

Intervention groups

1

Description
The study, which will be split-mouth. Two surgeries will be done in a patient, on the one side Mucograft material and the other side using graft that will be harvested from the palate of the patient. first premolar will be selected as target for gingival transplant surgery by mucograft material or graft that harvested from the palatal. by the Bjorn technique surgery will be done .The size of the graft material in both site will be 10 x 20 mm and used 5 suture for tissue fixation
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty Of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
dr Hadi Zare
Street address
Faculty Of Dentistry , North Karegar, Amir Abad
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Faculty Of Dentistry, Tehran University of Medical Sciences, Research department
Full name of responsible person
dr Amir Reza Rokn,
Street address
Reasearch assistant director
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty Of Dentistry, Tehran University of Medical Sciences, Research department
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
Faculty Of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Hadi Zare
Position
Resident of periodontics
Other areas of specialty/work
Street address
Periodontics department,Floor 3, North Karegar, Amir Abad
City
Tehran
Postal code
Phone
+98 21 8801 5950
Fax
Email
h-zare@razi.tums.ac.irdr_hadizare@yahoo.comdrhadizare@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty Of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Dr Amir reza Rokn
Position
Associate Professor of Periodontics
Other areas of specialty/work
Street address
Faculty Of Dentistry, North Karegar, Amir Abad
City
Tehran
Postal code
Phone
+98 21 8801 5950
Fax
Email
arrokon@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty Of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Hadi Zare
Position
resident of periodontics
Other areas of specialty/work
Street address
Faculty Of Dentistry, North Karegar, Amir Abad
City
Tehran
Postal code
Phone
+98 21 8801 5950
Fax
Email
h-zare@razi.tums.ac.irdr_hadizare@yahoo.comdrhadizare@gamil.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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