Protocol summary

Summary
Therapeutic target of the present study is to introduce a new technique for adjusting Adams clasp, which is the most important component involved in the retention of removable appliances, to provide greater retention and patient comfort. In the present double-blind randomized clinical trial, 45 patients, in the 17‒25 age range will be randomly selected from those referring to the Department of Orthodontics, Faculty of Dentistry, Tabriz University of Medical Sciences and the study will be performed at the time interval from 22-09-2014 to 19-02-2015. Four removable maxillary plaques will fabricate for each patient, which has two Adams clasps on first molars with hooks on both sides (in order to apply force on the plaque) on the middle portion of the palate along the mesial surfaces of first premolars with acrylic resin covering of the palate. One plaque will adjust from the area of both Adams clasps at overhead areas in the conventional technique. In the three remaining plaques, the Adams clasp will be bent by the Three-plong plier in the middle area of the bridge under three vertical angles of 8, 15 and 20 degrees .after placing the plate in the patients` oral cavity the degree of retention will be measured. For the blindness of the present study the plates will be randomly coded as A, B, C, and D.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014100819465N1
Registration date: 2014-10-28, 1393/08/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-10-28, 1393/08/06
Registrant information
Name
somaye naghinejad ahmadi
Name of organization / entity
tabriz university of medical sciences-dental faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5921
Email address
naghinejads@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-10-17, 1393/07/25
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial about comparison of novel adjustment with conventional techniques on orthodontic plates` retention
Public title
Effect of novel adjustment on plate`s retention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of first upper molars on both sides; Permanent dentition period; Absence of any rotation of first molars. Exclusion criteria: Patients with congenital maxillofacial syndromes; Patients whom upper first molars do not have proximal contacts on both sides; Lack of patient cooperation during recall visits.
Age
From 17 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences, Dental Faculty
Street address
Central building of University of Medical Sciences, Golgasht Ave. , Azadi st. , Tabriz, Iran
City
Tabriz
Postal code
5166713898
Approval date
2014-02-12, 1392/11/23
Ethics committee reference number
92204

Health conditions studied

1

Description of health condition studied
Retention of orthodontic plate
ICD-10 code
Z46.4
ICD-10 code description
Fitting and adjustment of orthodontic device

Primary outcomes

1

Description
Plate`s retention
Timepoint
Immediate
Method of measurement
Using a Correx Tension gauge by the scale of newton

Secondary outcomes

1

Description
Amount of bite opening
Timepoint
Immediate
Method of measurement
Using orthodontic gauge by the scale of millimeter

Intervention groups

1

Description
In the middle portion of the adams clasp`s bridge respectively angels of 0,8,15,20 degrees will be applied.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Orthodontics, Faculty of Dentistry
Full name of responsible person
Somaye Naghinejad Ahmadi
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Somaye Naghinejad Ahmadi
Street address
Central building of University of Medical Sciences, Golgasht Ave. , Azadi st. , Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences, Dental Faculty
Full name of responsible person
Somaye Naghinejad Ahmadi
Position
Resident of orthodontics
Other areas of specialty/work
Street address
Central building of University of Medical Sciences, Golgasht Ave. , Azadi st. , Tabriz, Iran
City
Tabriz
Postal code
5166713898
Phone
+98 41 3335 5921
Fax
Email
naghinjads@tbzmed.ac.ir; dr_naghinejad@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Mecical Sciences, Dental Faculty
Full name of responsible person
Behnam Mirzakouchaki
Position
Associate Professor
Other areas of specialty/work
Street address
Central building of University of Medical Sciences, Golgasht Ave. , Azadi st. , Tabriz, Iran
City
Tabriz
Postal code
5166713898
Phone
+98 41 3335 5921
Fax
Email
mirzakouchaki@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Somaye Naghinejad Ahmadi
Position
Resident of orthodontics
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 41 3335 5921
Fax
Email
naghinjads@tbzmed.ac.ir;
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
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