Comparison of Mucoderm with connective tissue on root coverage
Design
Pragmatic, community based, parallel group, double blind, randomized controlled trial
Settings and conduct
In patients with bilateral Miller class I and II gingival recessions , one side will be treated by mucoderm and the other side will be treated with connective tissue randomly. Patients and researcher won't know which side is treated by which material
Participants/Inclusion and exclusion criteria
Patients with bilateral Miller class I and II gingival recessions 2mm or more and those who do not smoke, Women who are not pregnant or breastfeeding, those who do not have systemic diseases which are contraindicated for surgery,patients who do not consume drugs affecting gingivae, patient with appropriate tooth brushing method like Stillman and patients with good oral hygiene. Teeth which are abutments for partial dentures, orthodontic brackets,
teeth that are crowns and decayed and have cervical fillings will be excluded
Intervention groups
For root coverage, Mucoderm will be used in one side and connective tissue will be used on the other side and root coverage percentage will be compared between the two groups
Main outcome variables
Evaluation of gingival recession, keratinized tissue width, gingival thickness, pocket depth and clinical attachment level before and after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140318017053N10
Registration date:2019-04-13, 1398/01/24
Registration timing:retrospective
Last update:2019-04-13, 1398/01/24
Update count:0
Registration date
2019-04-13, 1398/01/24
Registrant information
Name
Ferena Sayar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
f_sayar@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Mucoderm with connective tissue graft on root coverage in Miller class I and II gingival recessions
Public title
Comparison of Mucoderm with connective tissue graft on root coverage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Miller class I and II gingival recessions with 2 mm or more
Exclusion criteria:
Patients who smoke
Women who are pregnant or breastfeeding
Patients with systemic diseases which have surgical contraindications
Patients who consume drugs with adverse effects on gingivae
Patients with inappropriate oral hygiene
Teeth which are abutments for partial denture, orthodontic brackets, crowns, decays and cervical fillings
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Computer generated randomization list (Microsoft Excel 2010)
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigator and Data analyzer won't know which side is treated with Mocoderm and which side is treated with connective tissue.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Faculty of Dentistry Tehran Medical sciences , Islamic Azad University
Street address
No.4 , 10th Neyestan st. , Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585/175
Approval date
2018-02-28, 1396/12/09
Ethics committee reference number
IR.IAU.DENTAL.REC.1397.023
Health conditions studied
1
Description of health condition studied
Root coverage treatment
ICD-10 code
K05.5
ICD-10 code description
Root coverage treatment
Primary outcomes
1
Description
Root coverage percentage
Timepoint
Before surgery and 1, 3 and 6 month after surgery
Method of measurement
Gingival Recession depth measurement with Williams probe
Secondary outcomes
1
Description
Measurement of keratinized tissue, pocket depth and attachment level.
Timepoint
Before, 1, 3 and 6 months after therapy.
Method of measurement
By periodontal probe
Intervention groups
1
Description
Control group: grafting with connective tissue graft
Category
Treatment - Surgery
2
Description
Intervention group: grafting with Mucoderm
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontics department of Islamic Azad University
Full name of responsible person
Ferena Sayar
Street address
Pasdaran St, Neyestan9
City
Tehran
Province
Tehran
Postal code
19585107
Phone
+98 21 2256 4571
Email
f_sayar@dentaliau.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No 4, 9th Neyestan, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Fax
+98 21 2256 4570
Email
a_azizi@dentaliau.ac.ir
Web page address
http://dentaliau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?