Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000099426
Ethics application status
Approved
Date submitted
1/12/2024
Date registered
30/01/2025
Date last updated
30/01/2025
Date data sharing statement initially provided
30/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of retention of powder and paste form of denture adhesives in mandibular complete denture wearers by using spring scale
Scientific title
Comparison of retention of powder and paste form of denture adhesives in mandibular complete denture wearers by using spring scale
Secondary ID [1] 313499 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral and gastrointestinal 335925 0
Condition category
Condition code
Oral and Gastrointestinal 332515 332515 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
After informed consent participants will be divided into group A (powder denture adhesive) and group B (paste denture adhesive) by lottery method. Paper slips, each labeled with either group A or group B will be placed in a jar. Patients will be asked to randomly select one slip from the jar, and the content of the slip will determine their group assignment. This lottery method will ensure that each patient had an equal chance of being assigned to either group, eliminating bias in the group allocation process. All patients will be blinded to this group allocation. In order to minimize bias and ensure objective measurements, the data collection procedure will involve the participation of two investigators and a principal investigator. The first investigator, under supervision of principal investigator, will be responsible for application of denture adhesive and proper seating of complete denture in patient’s mouth. This setup allows for consistent application across all participants, reducing the potential of variability. The second investigator, also under the supervision of principal investigator, will be responsible for measuring the denture retention using spring scale. The second investigator will be blinded to the type of adhesive applied to maintain objectivity in the measurement process. The principal investigator will oversee the entire study and observe both investigators to ensure adherence to protocol and prevent any potential biases.
Group A patients’ measurement of denture retention without any denture adhesive application with Spring scale will serve as control value. Powder denture adhesive will be applied by first investigator as per manufacturer’s instruction and patient will be instructed to maintain non-forced intercuspation (bite) for 5 minutes. The second investigator will measure the denture retention by using spring scale and record it. Two additional measurements will be taken after 1 minute interval in order to eliminate error. Mean of these three retention measurements will be calculated to obtain a representative value for each patient. Same steps i.e. control measurements, adhesive application, non-forced intercuspation and retention measurements will be followed using the paste denture adhesive on patients of group B.

All investigators are prosthodontists
Intervention code [1] 330073 0
Treatment: Devices
Comparator / control treatment
Group A- powder group
Control group
Active

Outcomes
Primary outcome [1] 340035 0
To compare the retention of powder and paste form of denture adhesive in mandibular complete denture wearers by using spring scale.
Assessment method [1] 340035 0
Spring scale tool
Timepoint [1] 340035 0
5 mins after application of fixative
Secondary outcome [1] 443428 0
None
Assessment method [1] 443428 0
None
Timepoint [1] 443428 0
None

Eligibility
Key inclusion criteria
Edentulous patient with class 1 jaw relationship, mandibular resorbed ridge (order 5 and 6 according to Atwood’s classification) and well fabricated mandibular complete denture.
Minimum age
45 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neuromuscular incoordination (diagnosed by neurologist)

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
By using Open epi, the total calculated sample size was 30 by using mean of retention of complete denture (439.09 ± 168.47) powder group and (679.26± 218.26) mean of retention using paste group by keeping 95% confidence interval with 90% power test. In order to adjust the normality assumption of data and CPSP criteria we will take a total sample size of 30 in each group.

Data will be analyzed using SPSS version 27. Mean and standard deviation will be calculated for numerical variable like age and retention scores of both groups (powder and paste) while frequency and percentages will be calculated for categorical variable like gender,dry mouth and denture condition.
Normality of data will be checked through Shapiro-Wilk test. Independent sample T test (for normally distributed data) or the Mann-Whitney U-test (for skewed data) will be used to compare the effectiveness in terms of mean (± SD) of retention scores between groups of denture adhesive in mandibular complete denture. Similarly, this outcome will be stratified among age , gender ,dry mouth and denture condition by using Mann-Whitney U-test/independent sample T test. P value =0.05 will be considered significant. All data will be presented in the forms of tables and charts.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/09/2024
Date of last participant enrolment
Anticipated
Actual
14/11/2024
Date of last data collection
Anticipated
Actual
14/11/2024
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 26767 0
Pakistan
State/province [1] 26767 0
Khyber pakhtunkhuwa

Funding & Sponsors
Funding source category [1] 317948 0
Self funded/Unfunded
Name [1] 317948 0
Dr.Aiman Zafar
Country [1] 317948 0
Pakistan
Primary sponsor type
Hospital
Name
Khyber college of dentistry,Peshawar Pakistan
Country
Pakistan
Secondary sponsor category [1] 320286 0
University
Name [1] 320286 0
College of physician and surgeons
Country [1] 320286 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316624 0
Research Review Board,khyber college of dentistry, Peshawar
Ethics committee address [1] 316624 0
Ethics committee country [1] 316624 0
Pakistan
Date submitted for ethics approval [1] 316624 0
20/05/2023
Approval date [1] 316624 0
16/06/2023
Ethics approval number [1] 316624 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 138446 0
Ms Aiman Zafar
Address 138446 0
Khyber college of dentistry,Peshawar University campus,University Road,khyber pakhtunkhuwa,pakistan postcode25000
Country 138446 0
Pakistan
Phone 138446 0
+923324646332
Email 138446 0
amnzfr1@gmail.com
Contact person for public queries
Name 138447 0
Aiman Zafar
Address 138447 0
Khyber college of dentistry,University campus peshawar,pakistan postal code 25000
Country 138447 0
Pakistan
Phone 138447 0
+923324646332
Email 138447 0
amnzfr1@gmail.com
Contact person for scientific queries
Name 138448 0
Aiman Zafar
Address 138448 0
Khyber college of dentistry,University campus peshawar, Pakistan postal code25000
Country 138448 0
Pakistan
Phone 138448 0
+923324646332
Email 138448 0
amnzfr1@gmail.com

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• All concerned departments

Conditions for requesting access:
• -

What individual participant data might be shared?
• All variables of study
1.Retention scores
2.gender information
3.xerostomia
4.Denture old/new

What types of analyses could be done with individual participant data?
• Data analysis,article writing,proof reading and observation

When can requests for individual participant data be made (start and end dates)?
From:
From 20th December 2024 till 28th Feb 2025

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• By contacting principal investigator.
Email: amnzfr1@gmail.com

Are there extra considerations when requesting access to individual participant data?
No


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.