Objectives: The purpose of this study is to evaluate the effect of Simvastatin on tooth relapse after orthodontic tooth movements and its effect on the gingival index besides Clinical Attachment Loss.
Design: This is a single blinded, non-randomized clinical trial that is carried out parallel.
Setting and conduct: After attached all spaces with constant orthodontic instruments, gingival index besides Clinical Attachment Loss measured first for all the patients.
Participants including major eligibility criteria: Female patients with 4 to 6 mm space between front teeth of upper or lower gingival are entered to study. Besides patients under systemic therapy with simvastatin group medicines and sever periodontitis patients are excluded from this study.
Intervention: The patients will be divided into two equal groups. For the first group, normal saline injection as placebo carry out in the sixth front teeth depth pocket with 1.2 mg for each inter proximal section, two weeks after bleaching and for the second group, simvastatin injection carry out in the sixth front teeth depth pocket with 1.2 mg for each inter proximal section, two weeks after bleaching.
Main outcome and measures variables: The relapse will be measured through calculating the created space by photography and Smile Analyzer into two groups. Also gingival index besides Clinical Attachment Loss will be calculated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013041813054N1
Registration date:2013-11-04, 1392/08/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-04, 1392/08/13
Registrant information
Name
Parasto Namdar
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1883 0787
Email address
namdarp881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research chancellor of Mashhad University of Medical Sciences
Expected recruitment start date
2013-04-30, 1392/02/10
Expected recruitment end date
2014-05-10, 1393/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of subgingival injection of Simvastatin on prevention of the tooth relapse after orthodontic movements
Public title
Simvastatin effect on orthodontic relapse
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Female patients with 20 to 45 years old, with 4 to 6 mm space between front teeth of upper or lower gingival, controlled chronic periodontitis with Clinical Attachment Loss of 4 to 6 mm and without known allergy to simvastatin group medicines. Big tongue was not the cause of space.
Exclusion criteria: Patients under systemic therapy with simvastatin group medicines, pregnant or breath feeding patients, sever periodontitis patients, smoker or alcoholic patients, patients with diabetes or immunosuppressive diseases.
Age
From 20 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Postal code
91375-345
Approval date
2011-11-01, 1390/08/10
Ethics committee reference number
900303
Health conditions studied
1
Description of health condition studied
orthodontic relapse
ICD-10 code
Z46.4
ICD-10 code description
Fitting and adjustment of orthodontic device
Primary outcomes
1
Description
Gingival index
Timepoint
Before the study and eight weeks after injection in control and intervention group
Method of measurement
According to bleeding index
2
Description
Clinical Attachment Loss
Timepoint
Before the study and eight weeks after injection in control and intervention group
Method of measurement
By Probe
Secondary outcomes
empty
Intervention groups
1
Description
For control group: normal saline injection (1 .2 mg) in the sixth front teeth depth pocket, two weeks after bleaching
Category
Treatment - Drugs
2
Description
For intervention group: simvastatin injection in the sixth front teeth depth pocket with 1.2 mg for each inter proximal section, two weeks after bleaching
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad dentistry school
Full name of responsible person
Dr Arezo Jahanbin
Street address
Mashhad dentistry school, Azadi Square
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
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, Mashhad 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
Mashad University of Medical Sciences
Full name of responsible person
Dr Parasto Namdar
Position
orthodontic resident
Other areas of specialty/work
Street address
Mashhad dentistry school, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 1883 0787
Fax
Email
NamdarP881@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashad University of Medical Sciences
Full name of responsible person
Dr Arezo Jahanbin
Position
Associate Professor of orthodontic
Other areas of specialty/work
Street address
Mashhad dentistry school, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 1883 0787
Fax
Email
jahanbina@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashad University of Medical Sciences
Full name of responsible person
Dr Parasto Namdar
Position
orthodontic resident
Other areas of specialty/work
Street address
Mashhad dentistry school, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 1883 0787
Fax
Email
NamdarP881@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)