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Trial registered on ANZCTR
Registration number
ACTRN12618001647224
Ethics application status
Approved
Date submitted
29/09/2018
Date registered
5/10/2018
Date last updated
5/10/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Change in salivary pH under the effect of stainless steel versus elastomeric ligatures in selected group of orthodontic patients
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Scientific title
Change in salivary pH under the effect of stainless steel versus elastomeric ligatures in selected group of orthodontic patients : A randomized clinical trial
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Secondary ID [1]
296206
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Enamel demineralization due to drop in salivary pH during orthodontic treatment
309844
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Gingivitis
309845
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Condition category
Condition code
Oral and Gastrointestinal
308634
308634
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Each participant (selected group of orthodontic patients) will received one of the orthodontic ligature materials either stainless steel or elastomeric ligatures for 3 months followup in four interval time points ( T0,T1,T2 and T3 ) to compare change in salivary pH tested using a pH meter.
The research investigator will deliver the intervention in the orthodontic clinics of the University of Science and Technology Sana'a Yemen
Orthodontic ligatures are auxiliary components of fixed orthodontic appliances that ensure secure connection between the archwire and the brackets ,Stainless steel and elastomeric are the common materials from which archwire ligatures are fabricated
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Intervention code [1]
312537
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Treatment: Devices
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Comparator / control treatment
stainless steel ligature is the comparator or the control
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Control group
Active
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Outcomes
Primary outcome [1]
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change in salivary pH is assessed using a pH Meter device ( 3510,JENWAY ,UK )
in the four time-points followup interval
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Assessment method [1]
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Timepoint [1]
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(T0) baseline and then re-evaluated in three-time interval stages:
- (T1) : 2 weeks after placement of Fixed Orthodontic Appliance ( visit to recall maintenance and follow up).
- (T2) : 6 weeks after placement of FOA ( visit to change first archwire).
- (T3) : 12 weeks after placement of FOA (visits to change 2nd and 3rd archwires).
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Secondary outcome [1]
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Marginal Gingivitis is assessed using a plaque index
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Assessment method [1]
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Timepoint [1]
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(T0) baseline and then re-evaluated in three-time interval stages:
- (T1) : 2 weeks after placement of Fixed Orthodontic Appliance ( visit to recall maintenance and follow up).
- (T2) : 6 weeks after placement of FOA ( visit to change first archwire).
- (T3) : 12 weeks after placement of FOA (visits to change 2nd and 3rd archwires).
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Secondary outcome [2]
352510
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salivary flow rate
Saliva will be collected as per the protocol derived from the World Health
Organization ( WHO) /International Agency of Research (IAR) as follow :
Saliva samples will be obtained in the morning between 9 Am – 12pm.
Collecting of whole un-stimulated saliva through passsive drooling method
in a sterile measuring plastic tube with 1-ml gradation marks using labels
that recommended for freezing (cryolabels) with the horizontally labeling cod paper to
facilitate reading labels
salivary flow rate will be obtained by the equation :
quantity of saliva in the labiled tube / collection period (10 minutes ) = salivary flow rate ml / minute
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Assessment method [2]
352510
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Timepoint [2]
352510
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(T0) baseline assessment before placement ofthe ligature materials and then re-evaluated in three-time interval stages:
- (T1) : 2 weeks after placement of orthodontic ligature
( visit to recall maintenance and follow up).
- (T2) : 6 weeks after placement of orthodontic ligature
( visit to change first archwire).
- (T3) : 12 weeks after placement of orthodontic ligature (visits to change 2nd and 3rd archwires).
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Secondary outcome [3]
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Gingival bleeding tendancy tested using
bleeding index and or
ginvival index'
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Assessment method [3]
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Timepoint [3]
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(T0) baseline assessment before placement ofthe ligature materials and then re-evaluated in three-time interval stages:
- (T1) : 2 weeks after placement of orthodontic ligature
( visit to recall maintenance and follow up).
- (T2) : 6 weeks after placement of orthodontic ligature
( visit to change first archwire).
- (T3) : 12 weeks after placement of orthodontic ligature (visits to change 2nd and 3rd archwires).
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Secondary outcome [4]
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patient compliance to keep a good oral hyigen tested using
hygieneic index
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Assessment method [4]
352512
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Timepoint [4]
352512
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(T0) baseline assessment before placement ofthe ligature materials and then re-evaluated in three-time interval stages:
- (T1) : 2 weeks after placement of orthodontic ligature
( visit to recall maintenance and follow up).
- (T2) : 6 weeks after placement of orthodontic ligature
( visit to change first archwire).
- (T3) : 12 weeks after placement of orthodontic ligature (visits to change 2nd and 3rd archwires).
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Eligibility
Key inclusion criteria
Orthodontic patients with fixed orthodontic appliance in both upper and lower archs
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Minimum age
15
Years
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Maximum age
40
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- orthodontic patients with Chronic medication : antibiotic or anti-inflammatory
- orthodontic patients with Systemic diseases : diabetes mellitus, kidney diseases and respiratory infection.
- Mouth breathing, xerostomia , hyposalivation
- History of unusual dietary habits like highly acidic food or drink consumers .
Diagnosis of any Systemic diseases , mouth breathing , xerostomia and salivary gland hypofunction is dependent upon a careful and detailed history and thorough oral examination
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
seventy enclosed envelopes for both two groups will be prepared before the study by
orthodontist assistant. Each envelope containing the treatment allocation number which
represent either an stainless steel or elastomeric ligature choice in the performed allocation tables .
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A software randomization program (Research Randomizer) will be used to generate
random allocation tables that include random number sequences for the participants.
Two randomly sequencing numbered tables from 1 to 70 will be generate by the
software. Each table represents a group of type of archwire ligature either stainless steel or elastomeric.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
Implementation:
The orthodontist assistant is responsible for implementing the randomization process
that include:
- Generate the allocation sequences and preparation of the enclosed envelopes in
sequence numbers .
- Enrollment of the participants .
- Assignment of the participants into their groups .
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Phase
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The Shapiro-Wilk test will be applied to verify the normality of distribution of the
examined variable on the whole sample.
The Chi2-test will be used to establish whether a significant difference existed between
the numbers of patients in each group. Deviations from baseline will be tested for
significance with the Wilcoxon signed ranks test (one-tailed).
The t- test for independent samples will be applied for the comparison between two
groups of methods of archwire ligation, while the comparison between T0,T1,T2and T3
will carried out with the t-test for paired sample.
The level of significance set at 0.05. Statistical analyses performed using the statistical
software SPSS for Windows (version 25.0, SPSS Inc.,Chicago,IL,USA).
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
15/05/2018
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Date of last participant enrolment
Anticipated
15/02/2019
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Actual
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Date of last data collection
Anticipated
15/06/2019
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Actual
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Sample size
Target
70
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Accrual to date
31
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Final
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Recruitment outside Australia
Country [1]
20878
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Yemen
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State/province [1]
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Sana'a
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Science and Technology
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Address [1]
300796
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60 street /Mathbah / Sana'a / Yemen
Tel 00967 1 373 237
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Country [1]
300796
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Yemen
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Primary sponsor type
University
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Name
University of Science and Technology
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Address
60 street /Mathbah / Sana'a / Yemen
Tel 00967 1 373 237
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Country
Yemen
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Secondary sponsor category [1]
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None
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Name [1]
300350
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Address [1]
300350
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Country [1]
300350
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301578
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Ethical Committee of Medical Research
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Ethics committee address [1]
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University of Science and Technology
60 street / Mathbah
Sana'a / Yemen
Phone 00967 1 373237
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Ethics committee country [1]
301578
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Yemen
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Date submitted for ethics approval [1]
301578
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31/03/2018
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Approval date [1]
301578
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10/04/2018
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Ethics approval number [1]
301578
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EAC/UST126
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Summary
Brief summary
would be Stainless steal better than Elastomeric ligature for oral hygiene maintenance, and help keep salivary pH at a more favorable level and therefore decrease chance for enamel demineralization during fixed orthodontic treatment ?
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
3117
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/AnzctrAttachments/376097-??Hind Nasher -MDS. proposal22th.pdf
(Protocol)
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Attachments [2]
3118
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/AnzctrAttachments/376097-Ethical approval_2.pdf
(Ethics approval)
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Attachments [3]
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/AnzctrAttachments/376097(v29-09-2018-03-37-40)-Medical_Questionnaire.pdf
(Participant information/consent)
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Attachments [4]
3124
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/AnzctrAttachments/376097-Informed Consent Form1.pdf
(Participant information/consent)
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Contacts
Principal investigator
Name
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Dr Hind Abdulkareem Nasher AL-Hayfi
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Address
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Hind Abdulkareem Nasher AL-Hayfi
University Of Science and Technology
Collage Of Dentistry Department Of Biological and Preventive Sciences Orthodontic Unite
30/Television street /Sofan City
Sana'a / Yemen
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Country
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Yemen
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Phone
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+ 967 770878955
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Hind Abdulkareem Nasher AL-Hayfi
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Address
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Hind Abdulkareem Nasher AL-Hayfi
University Of Science and Technology
Collage Of Dentistry Department Of Biological and Preventive Sciences Orthodontic Unite
30/Television street /Sofan City
Sana'a / Yemen
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Country
87447
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Yemen
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Phone
87447
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+ 967 770878955
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Fax
87447
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Email
87447
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[email protected]
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Contact person for scientific queries
Name
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Dr Hind Abdulkareem Nasher AL-Hayfi
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Address
87448
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Hind Abdulkareem Nasher AL-Hayfi
University Of Science and Technology
Collage Of Dentistry Department Of Biological and Preventive Sciences Orthodontic Unite
30/Television street /Sofan City
Sana'a / Yemen
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Country
87448
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Yemen
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Phone
87448
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+ 967 770878955
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Fax
87448
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Email
87448
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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