Aim: The aim of this clinical trial is clinical & histological comparison of gingival tissue reaction to vicryl and silk sutures. Study design: Randomized, double blind, no placebo, one-centered. Population: Patients aged 20-40 years, both male and female. Inclusion criteria: Absence of systemic disease; patients required crown lengthening in maxillary premolar or molar teeth. Exclusion criteria: Systemic disease; smoking; receiving any type of local and systemic drugs which produced inflammation in gingival tissue or gingival inflammation in surgical site; patients who were received periodontal surgical treatment or antibiotic during past six months; pregnant women and allergy to silk or vicryl products. Sample size: Thirty-two samples in two groups; each containing 16 samples. Interventions: Suturing in the mesial and distal site of maxillary premolar & molar teeth and then removing gingival tissues containing suture materials for histological examination. Intervention duration: One week. Primary Result: Gingival index, the severity of presence acute & chronic inflammatory cells.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061612487N6
Registration date:2014-11-18, 1393/08/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-18, 1393/08/27
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
2013-02-12, 1391/11/24
Expected recruitment end date
2013-05-26, 1392/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial and Hystomorphometric Comparison of Tissue Reaction to Vicryl and Silk Sutures in Patients required Clinical Crown Lengthening
Public title
Comparison of Tissue Reaction to two Suture Material
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Absence of systemic disease; patients required crown lengthening in maxillary premolar or molar teeth. Exclusion criteria: Systemic disease; smoking; receiving any type of local and systemic drugs which produced inflammation in gingival tissue or gingival inflammation in surgical site; patients who were received periodontal surgical treatment or antibiotic during past six months; pregnant women and allergy to silk or vicryl products; Samples with insufficient length & depth for counting of acute & chronic inflammatory cells
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: In each patient, the mesial and distal sites of the selected tooth were sutured randomly via throwing the coin by one of the suture materials. Blindness: Histological investigation was carried out by another examiner who was blind to the selected suture for each sample.
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
2012-11-11, 1391/08/21
Ethics committee reference number
07859/D/910820
Health conditions studied
1
Description of health condition studied
Foreign body reaction
ICD-10 code
K06.9
ICD-10 code description
Disorder of gingiva and edentulous alveolar ridge, unspecified
Primary outcomes
1
Description
clinical Inflammation of the gingiva
Timepoint
Pretreatment and one week after the treatment
Method of measurement
Gingival index Loe and Sillness
2
Description
Histologic inflammation of the gingiva
Timepoint
Pretreatment and one week after the treatment
Method of measurement
Inflammatory cell count in histologic samples
Secondary outcomes
empty
Intervention groups
1
Description
Applying silk suture (Supa Medical Device, Tehran, Iran)
Category
Diagnosis
2
Description
Applying vicryl suture (Supa Medical Device, Tehran, Iran)
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontology Department, Dental School,Khorasgan Branch, Islamic Azad University
Full name of responsible person
Dr Shirin Amini
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay 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
Dr Vahid Esfahanian
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
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 31 3535 4053
Fax
Email
Sh.amini@khuisf.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental School, Khorasgan Branch, Islamic Azad University
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 3535 4043
Fax
+98 31 3535 4043
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
Elmira Guanji
Position
Dental student
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 3535 4043
Fax
Email
yasesefid744@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)