Clinical Trial of Comparison of Collagen Membrane and Space Maker With Subepithelial Connective Tissue Graft (Modified Method) in Treatment of Gingival Recession
Aim: The aim of this clinical trial is to compare the changes in clinical periodontal variables between two methods of guided tissue regeneration and connective tissue graft in the treatment of gingival recession. Study design: Randomized, single blind, no placebo, two-centered. Population: Patients aged 20-60 years, both male and female. Inclusion criteria: Class one or two Miller's gingival recessions with at least 3 mm depth in incisors and premolars; esthetic problem or root sensitivity (sensitivity is characterized by blowing air by means of air syringe on root surface for 3 seconds from 2 cm distance to the tooth and asking the patient regard root sensitivity); patient capability for plaque control. Exclusion criteria: Systemic disease; pregnancy; breastfeeding. Sample size: Twenty four samples in two groups; each containing 12 samples. Interventions: Utilization of collagen membrane with space maker and subepithelial connective tissue graft (modified method) in treatment of gingival recession. Investigation duration: six months. Primary Result: Pocket depth, clinical attachment level, depth and width of recession, width of keratinized tissue.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014051912487N5
Registration date:2014-06-14, 1393/03/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-14, 1393/03/24
Registrant information
Name
Shirin Amini
Name of organization / entity
Khorasgan Branch, Islamic Azad University, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1535 4053
Email address
sh.amini@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial of Comparison of Collagen Membrane and Space Maker With Subepithelial Connective Tissue Graft (Modified Method) in Treatment of Gingival Recession
Public title
Comparison of two Gingival Recession Treatment Techniques
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Class one or two Miller's gingival recession with at least 3 mm depth in incisors and premolars; esthetic problem or root sensitivity (sensitivity is characterized by blowing air by means of air syringe on root surface for 3 seconds from 2 cm distance to the tooth and asking the patient regard root sensitivity); patient capability for plaque control. Exclusion criteria: Systemic disease; smoking; gingival inflammation; allergy to collagen products
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The receded tooth in each site of a patient's mouth were randomly selected via throwing the coin to treat by one of the treatment methods. Blindness: All the variables were measured by another examiner who was blind to the selected treatment modalities for each tooth.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Khorasgan Branch, Islamic Azad University
Street address
Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavaniyeh street, Eastern Jey Street, Isfahan, Iran
City
Isfahan
Postal code
81595158
Approval date
2010-05-24, 1389/03/03
Ethics committee reference number
07301/D/890303
Health conditions studied
1
Description of health condition studied
Gingival recession
ICD-10 code
K06.9
ICD-10 code description
Gingival recession (post-operative)
Primary outcomes
1
Description
Probing depth
Timepoint
Before and one, 2, 3, 6 months after treatment
Method of measurement
Measuring of the pocket depth in mm by a Williams periodontal probe (Hu-Friedy, Chicago, IL, US)
2
Description
Clinical attachment level
Timepoint
Before and one, 2, 3, 6 months after treatment
Method of measurement
Measuring of the clinical attachment level in mm by a Williams periodontal probe (Hu-Friedy, Chicago, IL, US)
3
Description
Depth of gingival recession
Timepoint
Before and one, 2, 3, 6 months after treatment
Method of measurement
Measuring of the gingival recession depth in mm by a Williams periodontal probe (Hu-Friedy, Chicago, IL, US)
4
Description
Width of gingival recession
Timepoint
Before and one, 2, 3, 6 months after treatment
Method of measurement
Measuring of the gingival recession width in mm by a Williams periodontal probe (Hu-Friedy, Chicago, IL, US)
5
Description
Width of keratinised tissue
Timepoint
Before and one, 2, 3, 6 months after treatment
Method of measurement
Measuring of the keratinized tissue width in mm by a Williams periodontal probe (Hu-Friedy, Chicago, IL, US)
Secondary outcomes
empty
Intervention groups
1
Description
Connective tissue graft
Category
Treatment - Surgery
2
Description
Using of the collagen membrane (Biogide manufactured by Geistlich company,Wolhusen, Swiss) and space maker(Gingistat manufactured by GABA VEBAS srl , Rome, Italy)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Private practice and Department of Periodontology, Dental School,Khorasgan Branch, Islamic Azad Univ
Full name of responsible person
Dr Shirin Amini
Street address
Dental School, Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice- Chancellor of Islamic Azad University Khorasgan Branch
Full name of responsible person
Esfahanian, Vahid
Street address
Dental School, Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice- Chancellor of Islamic Azad University Khorasgan Branch
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
Department of Periodontology, Dental School, Khorasgan Branch, Islamic Azad University
Full name of responsible person
Dr Faraz Teimuri
Position
Assistant of Periodontology
Other areas of specialty/work
Street address
Dental School, Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1535 4053
Fax
Email
yasesefid744@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Full name of responsible person
Dr Shirin Amini
Position
Assistant Professor/ DDS, MSc
Other areas of specialty/work
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran
City
Isfahan
Postal code
81595158
Phone
+98 31 1535 4053
Fax
Email
Sh.amini@khuisf.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental School, Khorasgan Branch, Islamic Azad University( Isfahan)
Full name of responsible person
Dr Shirin Amini
Position
Assistant Professor/ DDS, MSc
Other areas of specialty/work
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran
City
Isfahan
Postal code
81595158
Phone
+98 3115
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)