Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001213730
Ethics application status
Approved
Date submitted
4/08/2022
Date registered
9/09/2022
Date last updated
9/09/2022
Date data sharing statement initially provided
9/09/2022
Date results information initially provided
9/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
To compare the hypersensitivity of two different bonds under composite restoration, on two different teeth of same patient. The bonds are three step total etch and one step universal bonding
Scientific title
Comparison of post-operative hypersensitivity between three step total etch and one step universal bonding technique: a randomized clinical trial in patients undergoing composite restoration on carious teeth
Secondary ID [1] 307132 0
None
Universal Trial Number (UTN)
U1111-1278-3044
Trial acronym
POH
Linked study record
NONE

Health condition
Health condition(s) or problem(s) studied:
post operative hypersensitivity 326307 0
Condition category
Condition code
Oral and Gastrointestinal 323620 323620 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
3M ESPE Scotchbond Universal adhesive system is a one step, single bottle, no mixing technique. It involves in the modification of smear layer; thence, is responsible for less hypersensitivity as claimed by their manufacturer.
Current study aimed at determining whether there is any difference in post operative hypersensitivity felt by the patients between the Total etch and Universal adhesive system.
All the restorations were performed and sensitivity were recorded by single operator (qualified dentist in post graduation training) in the department of Operative dentistry, Rawal Hospital. The two teeth were restored in the same clinic with no break in between.
Post-operative hypersensitivity (POH) was recorded by continuous visual analog scale (VAS of 0 – 10) before, immediately after and 24 hours after the placement of composite restoration using cold stimulus.
The hypersensitivity noted before the start of procedure was taken as a base line. The technique involved application of cold spray i.e. Tetrafluoroethane (TFE) on a small piece of cotton. This TFE soaked cotton was then applied on the mid facial surface of the tooth to measure hypersensitivity. The caries were removed by burs. After cavity preparation, Universal adhesive system was applied for 40 seconds by rubbing the entire preparation through micro brush. The surface was lightly air dried to remove the residual solvent. The second layer of adhesive was then reapplied and light cured for 20 seconds. Composite restoration was applied through incremental technique and light cured for 20 seconds. Sensitivity was recorded immediately after placement of restoration with composite.
Finishing was performed after 24 hours with carbide finishing bur and polishing brush. The sensitivity was recorded again at this time.
Duration for restoration was 20 to 30 minutes
Quantity of adhesive applied was 2 drops of adhesive from the bottle per tooth
Intervention code [1] 323744 0
Diagnosis / Prognosis
Comparator / control treatment
Total-etch (3M ESPE Adper Single bond plus Adhesive) was applied on the other tooth as a comparator treatment. All the restorations were performed on the same day without any break by single qualified dentist in the Department of Operative dentistry, Rawal Institute of Health Sciences (RIHS), Islamabad.
Post-operative hypersensitivity (POH) was recorded by continuous visual analog scale (VAS of 0 – 10) before, immediately after and 24 hours after the placement of composite restoration using cold stimulus.
Total etch requires multiple bottles and involves etching, rinsing and application of primer and bond. Total etch system requires removal of smear layer which is thought to be responsible for causing post- operative hypersensitivity but universal adhesive system involves in the modification of smear layer; thence, is responsible for less hypersensitivity as claimed by their manufacture. Moreover, Universal bond application is a single step procedure which consumes lesser time.
The hypersensitivity noted before the start of procedure was taken as a base line. The technique involved application of cold spray i.e.Tetrafluoroethane (TFE) on a small piece of cotton. This TFE soaked cotton was then applied on the mid facial surface of the tooth to measure hypersensitivity. Cavity was prepared by bur and then Total etch adhesive was applied in the following way: 37% Phosphoric acid was applied for 25 seconds on the prepared cavity. The acid was then washed by air and water pressure through triple syringe for 20 seconds. Then 2 coats of primer + bond were applied by rubbing through micro brush for 40 seconds. When the surface became shiny, it was light cured for 20 seconds. After application of bond, the composite material was applied in increments of 1-2 mm layer thickness in both cases (Universal adhesive as well as on Total-etch technique). Curing each increment was done for 20 second.
Sensitivity was recorded immediately after placement of restoration with composite.
Finishing was performed after 24 hours with carbide finishing bur and polishing brush. The sensitivity was recorded again at this time.
Duration for restoration was 30 to 40 minutes
Quantity of adhesive applied was 2 drops of adhesive from the bottle per tooth
Control group
Active

Outcomes
Primary outcome [1] 331620 0
Post- Operative hypersensitivity on VAS before applying universal bonding.
(Post operative hypersensitivity on VAS is taken before cavity preparation i.e. at that time no three step /universal bond was applied)
Timepoint [1] 331620 0
immediately after placement
(Post operative hypersensitivity on VAS is taken after three step /universal bond application and composite restoration)
Secondary outcome [1] 410557 0
post operative hypersensitivity on VAS after applying total etch bonding system
Timepoint [1] 410557 0
24 hours after placement
(Post operative hypersensitivity on VAS is taken 24 hours after completing the composite restoration i.e. the next day)

Eligibility
Key inclusion criteria
Patients of both genders between ages 16-50 years with at least 2 teeth requiring composite restoration were included in the study
Minimum age
16 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients having systemic diseases like un-controlled diabetes, mentally handicapped or with parafunctional habits such as bruxism, clenching teeth etc. were excluded.Teeth with increased pre-operative sensitivity or non- vital teeth with pulp necrosis or with irreversible pulpitis or grossly carious teeth with cavities extending near to pulp were also excluded from the study

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)
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


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data was analyzed using SPSS version 20. Independent sample T test was applied. P-value < 0.05 was considered significant

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/01/2019
Date of last participant enrolment
Anticipated
Actual
21/08/2019
Date of last data collection
Anticipated
Actual
21/08/2019
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 24820 0
Pakistan
State/province [1] 24820 0
Islamabad, Capital territory

Funding & Sponsors
Funding source category [1] 311436 0
Self funded/Unfunded
Name [1] 311436 0
Kiran Javed
Country [1] 311436 0
Pakistan
Primary sponsor type
Individual
Name
Kiran Javed
Address
Department of Operative dentistry, Rawal Institute of Health Sciences (RIHS), Lehtrar road,
Khanna pul, Islamabad
Country
Pakistan
Secondary sponsor category [1] 312831 0
Hospital
Name [1] 312831 0
Rawal Institute of Health Sciences
Address [1] 312831 0
Rawal Institute of Health Sciences, Lehtrar road, Khanna pul, Islamabad
Country [1] 312831 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310914 0
Ethics Committee Rawal Institute of Health Sciences
Ethics committee address [1] 310914 0
Rawal Institute of Health Science, Lehtrar Road, Khanna Pul, Islamabad
Ethics committee country [1] 310914 0
Pakistan
Date submitted for ethics approval [1] 310914 0
Approval date [1] 310914 0
05/01/2019
Ethics approval number [1] 310914 0

Summary
Brief summary
Objective: To determine and compare the mean post-operative hypersensitivity of three step Total-etch technique and one step Universal bonding technique following composite restoration in two different teeth of the same patient.
Design: A Randomized clinical trial
Place and duration of study: Department of Operative dentistry, Rawal Institute of Health Sciences (RIHS), Islamabad from Jan 2019 to Jan 2020.

Methodology: 100 patients were selected by consecutive sampling. Composite restorations were performed on two different teeth of the same patient by applying 3M ESPE Scotchbond Universal adhesive on one tooth and Total-etch (3M ESPE Adper Single bond plus Adhesive) on another tooth. The bonds and teeth were selected randomly. All the restorations were performed by single operator. Post-operative hypersensitivity (POH) was recorded by continuous visual analog scale (VAS of 0 – 10) before, immediately after and 24 hours after the placement of composite restoration using cold stimulus. Data was analyzed using SPSS version 20. Independent sample T test was applied. P-value < 0.05 was considered significant.

Result: No significant association was found between POH of Total etch and Universal bond technique before (p-value= 0.7), immediately after (p-value= 0.87) and 24 hours after (p-value= 0.67) the restoration. Gender analysis showed significant association (p < 0.05) with Total etch adhesive i.e. before (p-value= 0.003), immediately after (p-value=0.04) and 24 hours after (p-value=0.001) the restoration. Males showed more hypersensitivity as compared to females’ restorations (p-value< 0.05). Insignificant association of hypersensitivity was found between males and females with Universal adhesive system at any time (p-value >0.05).

Conclusion: No significant difference in POH was found between the two materials when a good sample size and proper technique was observed along with the removal of patients’ pain perception bias.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119326 0
Dr KIRAN JAVED
Address 119326 0
Department of Operative dentistry, Rawal Institute of Health Science, Lehtrar Road, Khanna Pul, Islamabad
Country 119326 0
Pakistan
Phone 119326 0
+923349557439
Fax 119326 0
Email 119326 0
kiran1406@yahoo.com
Contact person for public queries
Name 119327 0
Dr KIRAN JAVED
Address 119327 0
Department of Operative dentistry, Rawal Institute of Health Science, Lehtrar Road, Khanna Pul, Islamabad
Country 119327 0
Pakistan
Phone 119327 0
+923349557439
Fax 119327 0
Email 119327 0
kiran1406@yahoo.com
Contact person for scientific queries
Name 119328 0
Dr KIRAN JAVED
Address 119328 0
Department of Operative dentistry, Rawal Institute of Health Science, Lehtrar Road, Khanna Pul, Islamabad
Country 119328 0
Pakistan
Phone 119328 0
+923349557439
Fax 119328 0
Email 119328 0
kiran1406@yahoo.com

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16831Informed consent form    384067-(Uploaded-04-08-2022-23-16-24)-Study-related document.docx
16832Ethical approval    384067-(Uploaded-04-08-2022-23-00-34)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 384067-(Uploaded-31-08-2022-18-58-39)-Basic results summary.pdf
Plain language summaryNo No major difference in Post operative hypersensiti... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseComparison of postoperative hypersensitivity between Total-etch and Universal adhesive system: a randomized clinical trial.2024https://dx.doi.org/10.1038/s41598-024-51175-8
N.B. These documents automatically identified may not have been verified by the study sponsor.