Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001066471
Ethics application status
Approved
Date submitted
24/06/2025
Date registered
30/09/2025
Date last updated
30/09/2025
Date data sharing statement initially provided
30/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study on Tooth Sensitivity After Dental Fillings Using Self-Etch and Total-Etch Adhesives
Scientific title
Post-operative Sensitivity in Teeth Restored with Posterior Dental Composites using Self-Etch and Total-Etch Adhesives: Randomized Controlled Trial
Secondary ID [1] 314732 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tooth sensitivity 337942 0
Teeth Restoration 338723 0
Condition category
Condition code
Oral and Gastrointestinal 334264 334264 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
Group A (Self-Etch Adhesive):
Patients in this group will receive Class I composite restorations using a self-etch adhesive system (Prime Dental, USA). The adhesive will be applied for 20 seconds and light-cured for 10 seconds according to the manufacturer’s instructions. Composite resin (Ezfil Dental Composite Resin) will be placed incrementally and light-cured for 20 seconds per increment. Finishing will be done using diamond burs.
The self-etch adhesive will be applied once during a single restorative procedure (approximately 1 hour) on posterior teeth with Class I caries.
A bottled self-etch bonding agent (Prime Dental USA) will be applied directly to the prepared cavity using a disposable micro-brush for 20 seconds and then light cured for 10 seconds, according to the manufacturer’s instructions.
A qualified dentist (operator) will perform the procedure under rubber dam isolation in a dental operatory setting.
Adherence will be ensured by direct observation of the procedure by the operator and documented in patient records. Postoperative sensitivity will be monitored and recorded using a Visual Analogue Scale (VAS) 24 hours after treatment and during follow-up.
Intervention code [1] 331338 0
Treatment: Devices
Comparator / control treatment
The total-etch group (Group B) serves as the control/comparator against which the self-etch adhesive system (Group A) is being evaluated. In this group:
30–40% phosphoric acid gel is applied to enamel and dentin for 20 seconds
The etched surface is rinsed with water for 10 seconds
A bonding agent (Ezfil Dental Composite Resin) is applied and light-cured for 10 seconds
Composite resin is placed incrementally and light-cured for 20 seconds
Finishing is done with diamond burs
The total-etch adhesive will be applied once during a single restorative procedure (approximately 1 hour) on posterior teeth with Class I caries.
A 30–40% phosphoric acid gel will be applied to the prepared cavity for 20 seconds, then rinsed with water for 10 seconds and dried. A bonding agent (Ezfil Dental Composite Resin) will be applied using a disposable micro-brush and light cured for 10 seconds, followed by incremental placement of composite and curing for 20 seconds each layer.
A qualified dentist (operator) will carry out the procedure under rubber dam isolation in a dental operatory setting.
Adherence will be ensured by direct observation of the procedure by the operator and documented in patient records. Postoperative sensitivity will be monitored and recorded using a Visual Analogue Scale (VAS) 24 hours after treatment and during follow-up.
Control group
Active

Outcomes
Primary outcome [1] 341931 0
Postoperative sensitivity in posterior teeth restored with self-etch vs total-etch adhesives, measured using the Visual Analogue Scale (VAS).
Timepoint [1] 341931 0
The VAS score will be recorded: Primary Timepoint: 24 hours after the restoration procedure – Postoperative sensitivity will be assessed using the Visual Analogue Scale (VAS). Secondary Timepoint: 4 weeks after the restoration procedure – Follow-up assessment of postoperative sensitivity will be conducted via telephone call using the VAS, with particular focus on cold sensitivity.
Secondary outcome [1] 451681 0
Presence or absence of cold sensitivity in restored teeth.
Timepoint [1] 451681 0
4 weeks after the restoration procedure.

Eligibility
Key inclusion criteria
Patients of both genders
Aged 18 years or older
Vital maxillary or mandibular posterior teeth
Teeth requiring Class I composite restorations
Radiographic evidence of D1 lesions (caries in the outer third of dentin)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA III–VI patients
Periodontal disease
Use of desensitizing products (toothpaste or mouthwash)
History of parafunctional oral habits

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)
Allocation concealment will be achieved using sealed, opaque envelopes, prepared in advance and numbered sequentially.
The envelopes were opened only after the patient met inclusion criteria and gave consent, thus preventing selection bias and preserving randomization integrity
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization was used to generate the allocation sequence.
Participants were randomly assigned to either the self-etch group (Group A) or total-etch group (Group B) using the lottery method, ensuring each participant had an equal chance of assignment.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
30/12/2025
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment outside Australia
Country [1] 27138 0
Pakistan
State/province [1] 27138 0
Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 319285 0
University
Name [1] 319285 0
Khyber college of dentistry university of peshawar
Country [1] 319285 0
Pakistan
Primary sponsor type
University
Name
Khyber college of dentistry university of peshawar
Address
Country
Pakistan
Secondary sponsor category [1] 321758 0
Individual
Name [1] 321758 0
Doctor Aliya shah postgraduate resident KCD Peshawar
Address [1] 321758 0
Country [1] 321758 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317861 0
Research Review Board khyber college of dentistry
Ethics committee address [1] 317861 0
Ethics committee country [1] 317861 0
Pakistan
Date submitted for ethics approval [1] 317861 0
10/06/2024
Approval date [1] 317861 0
15/05/2025
Ethics approval number [1] 317861 0

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

Contacts
Principal investigator
Name 142390 0
Dr Aliya Shah
Address 142390 0
khyber college of dentistry KCD, university of peshawar pakistan postal code 25000
Country 142390 0
Pakistan
Phone 142390 0
+923339987080
Fax 142390 0
Email 142390 0
[email protected]
Contact person for public queries
Name 142391 0
Aliya Shah
Address 142391 0
khyber college of dentistry university of peshawar pakistan postal code 25000
Country 142391 0
Pakistan
Phone 142391 0
+923339987080
Fax 142391 0
Email 142391 0
[email protected]
Contact person for scientific queries
Name 142392 0
Aliya Shah
Address 142392 0
khyber college of dentistry university of peshawar pakistan postal code 25000
Country 142392 0
Pakistan
Phone 142392 0
+923339987080
Fax 142392 0
Email 142392 0
[email protected]

Data sharing statement
Will the study consider sharing 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.