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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
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
Secondary ID [1] 296206 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Enamel demineralization due to drop in salivary pH during orthodontic treatment 309844 0
Gingivitis 309845 0
Condition category
Condition code
Oral and Gastrointestinal 308634 308634 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 312537 0
Treatment: Devices
Comparator / control treatment
stainless steel ligature is the comparator or the control
Control group
Active

Outcomes
Primary outcome [1] 307594 0
change in salivary pH is assessed using a pH Meter device ( 3510,JENWAY ,UK )
in the four time-points followup interval
Timepoint [1] 307594 0
(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).
Secondary outcome [1] 352380 0

Marginal Gingivitis is assessed using a plaque index
Timepoint [1] 352380 0
(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).
Secondary outcome [2] 352510 0
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

Timepoint [2] 352510 0
(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).
Secondary outcome [3] 352511 0
Gingival bleeding tendancy tested using
bleeding index and or
ginvival index'
Timepoint [3] 352511 0
(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).
Secondary outcome [4] 352512 0
patient compliance to keep a good oral hyigen tested using

hygieneic index
Timepoint [4] 352512 0
(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).

Eligibility
Key inclusion criteria
Orthodontic patients with fixed orthodontic appliance in both upper and lower archs
Minimum age
15 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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 .

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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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 .
Phase
Type of endpoint/s
Efficacy
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).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/05/2018
Date of last participant enrolment
Anticipated
15/02/2019
Actual
Date of last data collection
Anticipated
15/06/2019
Actual
Sample size
Target
70
Accrual to date
31
Final
Recruitment outside Australia
Country [1] 20878 0
Yemen
State/province [1] 20878 0
Sana'a

Funding & Sponsors
Funding source category [1] 300796 0
University
Name [1] 300796 0
University of Science and Technology
Country [1] 300796 0
Yemen
Primary sponsor type
University
Name
University of Science and Technology
Address
60 street /Mathbah / Sana'a / Yemen
Tel 00967 1 373 237
Country
Yemen
Secondary sponsor category [1] 300350 0
None
Name [1] 300350 0
Address [1] 300350 0
Country [1] 300350 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301578 0
Ethical Committee of Medical Research
Ethics committee address [1] 301578 0
Ethics committee country [1] 301578 0
Yemen
Date submitted for ethics approval [1] 301578 0
31/03/2018
Approval date [1] 301578 0
10/04/2018
Ethics approval number [1] 301578 0
EAC/UST126

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3117 3117 0 0
/AnzctrAttachments/376097-??Hind Nasher -MDS. proposal22th.pdf (Protocol)
Attachments [2] 3118 3118 0 0
/AnzctrAttachments/376097-Ethical approval_2.pdf (Ethics approval)
Attachments [3] 3123 3123 0 0
/AnzctrAttachments/376097(v29-09-2018-03-37-40)-Medical_Questionnaire.pdf (Participant information/consent)
Attachments [4] 3124 3124 0 0
/AnzctrAttachments/376097-Informed Consent Form1.pdf (Participant information/consent)

Contacts
Principal investigator
Name 87446 0
Dr Hind Abdulkareem Nasher AL-Hayfi
Address 87446 0
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
Country 87446 0
Yemen
Phone 87446 0
+ 967 770878955
Fax 87446 0
Email 87446 0
[email protected]
Contact person for public queries
Name 87447 0
Hind Abdulkareem Nasher AL-Hayfi
Address 87447 0
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
Country 87447 0
Yemen
Phone 87447 0
+ 967 770878955
Fax 87447 0
Email 87447 0
[email protected]
Contact person for scientific queries
Name 87448 0
Hind Abdulkareem Nasher AL-Hayfi
Address 87448 0
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
Country 87448 0
Yemen
Phone 87448 0
+ 967 770878955
Fax 87448 0
Email 87448 0
[email protected]

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

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