Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000958583
Ethics application status
Approved
Date submitted
30/08/2023
Date registered
7/08/2024
Date last updated
7/08/2024
Date data sharing statement initially provided
7/08/2024
Date results provided
7/08/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Silver Diamine Fluoride (SDF) on tooth sensitivity
Scientific title
The effect of Silver Diamine Fluoride (SDF) on hyper sensitivity in dentistry patients
Secondary ID [1] 310497 0
nil
Universal Trial Number (UTN)
U1111-1297-2857
Trial acronym
SDF
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
tooth caries 331290 0
Condition category
Condition code
Oral and Gastrointestinal 330079 330079 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
38% silver diamine flouride. The participants in the Group A receive min. 0.1ml of single application of SDF on each tooth with root caries for at least 1 minute, according to the manufacturer's instructions.
The teeth are isolated with cotton rolls and gently dried. dentist will apply SDF with a disposable microbrush. the duration of visit is approximately 15 -20 minutes.
In our study, a treatment approach involving two visits is utilized. During the initial visit, the dentin undergoes a slight brown discoloration as a result of the application of SDF to root caries lesion. On next visit after a week, the root caries display darker color and increased hardness. Thus facilitating cavity preparation and subsequent composite restoration. This protocol ensures that the visual and tactile criteria are adequate for assessing the caries status on the second visit
Intervention code [1] 326887 0
Treatment: Drugs
Comparator / control treatment
5% sodium flouride varnish-
Group B - Participants in the control group received 5% NaF sodium fluoride varnish of min 0.1 ml ,applied to teeth with root caries by microbrush for 2 minutes minimum.
the dentist will apply Naf varnish.The teeth are isolated with cotton rolls and gently dried. NaF is applied .the duratio of study is at least 15 minutes for one visit
Control group
Active

Outcomes
Primary outcome [1] 335918 0
tooth hypersensitivity by triple airway syringe for at least 3 seconds. patient will report hyper-response and grading the response of the patient on a severity scale, 0 to 3.
Timepoint [1] 335918 0
base line (pre-treatment) and 1-month post initiation of treatment
Secondary outcome [1] 426139 0
caries progression- active or arrested lesion assessed by visual and tactile (blunt explorer)
Timepoint [1] 426139 0
base line (pre-treatment) and 1-month post initiation of treatment

Eligibility
Key inclusion criteria
hypersenstivity in teeth
Minimum age
6 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
oral infection

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomization sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
chi square test and frequency. 90 patients with caries lesions are assigned to two groups: Group A received 38% SDF, and Group B received 5% NaF sodium fluoride varnish. Follow-up assessments are conducted at one month, evaluating caries arrest through clinical examinations and patient-reported outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/06/2022
Date of last participant enrolment
Anticipated
Actual
10/04/2023
Date of last data collection
Anticipated
Actual
1/08/2023
Sample size
Target
120
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 25734 0
Pakistan
State/province [1] 25734 0
punjab

Funding & Sponsors
Funding source category [1] 316199 0
Self funded/Unfunded
Name [1] 316199 0
nil
Country [1] 316199 0
Primary sponsor type
Hospital
Name
bakhtawar amin
Address
northern bypass multan
Country
Pakistan
Secondary sponsor category [1] 318381 0
None
Name [1] 318381 0
Address [1] 318381 0
Country [1] 318381 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313714 0
bakhtawar amin dental ethical review board
Ethics committee address [1] 313714 0
Ethics committee country [1] 313714 0
Pakistan
Date submitted for ethics approval [1] 313714 0
Approval date [1] 313714 0
10/06/2022
Ethics approval number [1] 313714 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129110 0
Dr hafiz adil
Address 129110 0
dr hafiz adil baktawar amin medical and dental college Northern bypass multan 60000
Country 129110 0
Pakistan
Phone 129110 0
+9203115066698
Fax 129110 0
Email 129110 0
[email protected]
Contact person for public queries
Name 129111 0
jazib pervez
Address 129111 0
baktawar amin medical and dental college Northern bypass multan 60000
Country 129111 0
Pakistan
Phone 129111 0
+9203334627464
Fax 129111 0
Email 129111 0
[email protected]
Contact person for scientific queries
Name 129112 0
jazib pervez
Address 129112 0
baktawar amin medical and dental college Northern bypass multan 60000
Country 129112 0
Pakistan
Phone 129112 0
+9203334627464
Fax 129112 0
Email 129112 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Documents were uploaded by study researchers but have since been removed.

Documents added automatically
No additional documents have been identified.