1. Home
  2. Approved trials
  3. » فارسی

The Comparison of Acellular Dermal Matrix Allograft (CenoDerm) and a Subepithelial Connective Tissue Graft for the Treatment of Gingival Recession.

Protocol summary

Summary
Gingival Recession may lead to increase in dental sensitivity, pain, hardship of oral hygienic activities, root cavity, inappropriate gingival appearance, as well as missing periodontal connections. There are various treatment methods for root coverage. Acellular dermal grafts, although being of the high cost of Subepithelial Connective Tissue, is applied, because of its numerous advantages, especially in young people, old ages, and also the patients who are not able to have vast operations on, because of their systemic diseases. The present research aims at clinically comparing the Acellular Dermal Matrix Allograft (CenoDerm) along with Subepithelial Connective Tissue Graft, is used for the Treatment of Gingival Recession. There were twelve patients referred to the periodontics department of Babol Dentistry School in order to treat two-sided individual gingival recession. They will be selected according to the entry criteria (enough Vestibule depth, etc.), exclusion (pregnancy, etc.). The area to be operated on would be randomly divided into two parts in each person (totally 24 areas). One part would be treated through Transport Coronal flap with connective tissue graft placement method [CPF (coronally positioned flap ) + CTG (Connective Tissue Graft )]and the other part by Acellular Dermal Matrix Allograft (Ceno-Derm) (manufactured by replicating tissues Creed) and coronal displacement of the flap can be treated. All the surgeries are done by one person. Afterwards, during the surgery and intervals of one, three, and six months, the variables would be recorded by another one. In all the sessions of measuring the variables, clinical photography is done. The statistical data would be measured through SPSS. Morover, in order to analyze the variables, the Wilcoxon Singed Rank Test as well as the Mann-Whitney Test will be applied

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201305201760N23
Registration date: 2013-08-23, 1392/06/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-08-23, 1392/06/01
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Acellular Dermal Matrix Allograft (CenoDerm) and a Subepithelial Connective Tissue Graft for the Treatment of Gingival Recession.
Public title
The Comparison of Acellular Dermal Matrix Allograft (CenoDerm) and a Subepithelial Connective Tissue Graft for the Treatment of Gingival Recession.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Analysis of single-sided facial tissue depth of 2mm ≤ X CEJ in teeth or premolars; All sub-group analyzes of Miller class I / II; Selected teeth without fillings and no bleeding after probing; Persons 18 years and older; Ability to maintain good oral hygiene (% 20 O'Leary plaque score ≤); Vestibule depth of enough. Exclusion criteria: Pregnancy; use of drugs interfering with wound healing (corticosteroids, anti-cancer), or medicines that may cause gingival enlargement; Smoking; which prohibits any local or systemic disease, periodontal surgery is prescribed; Traumatic brushing methods; Hard toothbrushes or toothpaste abrasives; History of periodontal surgery in the past 2 years; The use of removable prosthodontic or orthodontic appliances in the area.
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Ganjafroz Road, Babol University of Medical Sciences
City
Babol
Postal code
Approval date
2013-05-14, 1392/02/24
Ethics committee reference number
2458

Health conditions studied

1

Description of health condition studied
Gingival recession
ICD-10 code
K06.0
ICD-10 code description
Gingival recession

Primary outcomes

1

Description
Treatment of Gingival Recession.
Timepoint
1 month, 3 months, 6 months after surgery.
Method of measurement
Clinical photography

Secondary outcomes

1

Description
Clinical attachment level
Timepoint
1 month, 3 months, 6 months after surgery
Method of measurement
Clinical (in mm)

2

Description
Probing depth
Timepoint
1 month, 3 months, 6 months after surgery
Method of measurement
Clinical (in mm)

3

Description
Gingival thickness
Timepoint
1 month, 3 months, 6 months after surgery
Method of measurement
Clinical (in mm)

4

Description
Mgj distance to CEJ
Timepoint
1 month, 3 months, 6 months after surgery
Method of measurement
Clinical (in mm)

5

Description
Vertical recession depth (VRD)
Timepoint
1 month, 3 months, 6 months after surgery
Method of measurement
Clinical (in mm)

6

Description
Healing
Timepoint
1 month, 3 months, 6 months after surgery
Method of measurement
Landry Index

7

Description
Cosmetic results
Timepoint
1 month, 3 months, 6 months after surgery
Method of measurement
Aesthetic Index (VAS)

8

Description
Discomfort after surgery
Timepoint
1 month, 3 months, 6 months after surgery
Method of measurement
Indexed pain (VAS)

Intervention groups

1

Description
Control group: Transport Coronal flap with connective tissue graft placement method is treated [CPF(coronally positioned flap ) + CTG(Connective Tissue Graft )]
Category
Treatment - Surgery

2

Description
Intervention group: With Acellular dermal matrix allograft (CenoDerm) (manufactured by replicating tissues Creed) and coronal displacement of the flap can be treated. [ADMA(Acellular Dermal Matrix Allograft)+CPF(coronally positioned flap)]
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental colleges of Babol
Full name of responsible person
Dr. Masoomeh Haghpanah Aski
Street address
Dental Colleges of Babol
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
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 and Technology, Babol 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
Dental College of Babol
Full name of responsible person
Dr. Masoomeh Haghpanah Aski
Position
Postgraduate Periodontics
Other areas of specialty/work
Street address
Dental College, Babol University of Medical Sciences
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
Email
parya_haghpanah@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental College of Babol
Full name of responsible person
Dr. Nilofar Jenabian
Position
Periodontics
Other areas of specialty/work
Street address
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
Postal code
Phone
+98 11 1222 7667
Fax
Email
parya_Haghpanah@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Fatemehzahra Infertility & Reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible of Reseach Center
Other areas of specialty/work
Street address
City
Babol
Postal code
Phone
00
Fax
Email
ngh_pa@yahoo.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
Loading...