SensitivityEPSBNNCT03792178
Evaluation of Post-operative Sensitivity of Bulk Fill Resin Composite Versus the Nano Resin Composite.
A study testing Bulk fill composite and Nano resin composite in people with Sensitivity, run by Rasmia Mamdouh Ali Salem.
Trial summary
Our study evaluated and compared the postoperative sensitivity of the placement technique (incremental and bulk fill) in class II posterior composite resin restorations bonded with two different adhesive strategies (self-etch and etch-and-rinse).Sixty patients were randomly selected, their age range from 25 to 40… Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Sensitivity
- What is being tested?
- Bulk fill composite and Nano resin composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 25 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must show no signs of spontaneous dental or orofacial pain.
- The presence of molar and premolar class II teeth requiring composite restorations for the treatment of primary carious lesions
- The selected teeth should have an occlusal contact with natural or crowned antagonist teeth
- The selected teeth should have a proximal contact with the adjacent teeth.
- Shallow and mid-sized cavity depths will be included in the study .
Who cannot join
- Increasing pre-operative sensitivity of the selected teeth.
- Teeth with abnormal periapical anatomy or caries that will be likely to result in very deep restorations.
- Teeth with old restorations or severely destructed dental crowns.
- Teeth with spontaneous pain
- Tempro-mandibular joint problems involving symptomatic pain.
- Patients taking analgesics that could alter their normal pain perception level.
- Pregnancy or breast feeding, acute and chronic systemic diseases, immunecompromised patients.
About this study
Our study evaluated and compared the postoperative sensitivity of the placement technique (incremental and bulk fill) in class II posterior composite resin restorations bonded with two different adhesive strategies (self-etch and etch-and-rinse).Sixty patients were randomly selected, their age range from 25 to 40 years old. They were divided into 2 main groups according to the packing technique of composite material; incremental Tetric Evoceram and Tetric Evoceram bulk fill composite.30 patients (n=30) were selected for incremental Tetric Evoceram composite restorations and they were equally divided according to the adhesive systems used (etch and rinse or self-etch adhesive strategy) (n=15 teeth).30 patients (n=30) were selected for Tetric Evoceram bulk fill composite restorations and they were equally divided according to the adhesive systems used (etch and rinse or self-etch adhesive strategy) (n=15 teeth).Post-operative pain assessed at 24 hours, 1 week and 1 month using the visual Analog Scale Score (VAS).Each patient was instructed to place a vertical mark on the VAS line at home to indicate the intensity of pain at each assessment period.
Read the detailed description
Our results revealed that when the two composite types using self-etch adhesive system \& total-etch adhesive system were evaluated; there was no statistically significant difference between the two composite types after 1 day, 1 week as well as 1 month.
When the two adhesive systems were compared using Bulk Fill composite \& incremental Nano resin composite there was no statistically significant difference between the two adhesive systems after 1 day, 1 week as well as 1 month.
Using Bulk Fill composite with self-etch adhesive; there was a statistically significant decrease in prevalence of hypersensitivity after 1 week. There were no cases with hypersensitivity after 1 week as well as 1 month. Using Bulk Fill composite with Total etch adhesive; there was a statistically significant decrease in prevalence of hypersensitivity after 1 week as well as from 1 week to 1 month.
Using Incremental Nano resin composite with self-etch adhesive; there was a statistically significant decrease in prevalence of hypersensitivity after 1 week as well as from 1 week to 1 month. Using Incremental Nano resin composite with Total etch adhesive; there was a statistically significant decrease in prevalence of hypersensitivity after 1 week as well as from 1 week to 1 month.
- Conditions
- Sensitivity
- Being tested
- Bulk fill composite, Nano resin composite
- Keywords
- Post operative sensitivity
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulk fill compositeOther
Composite resin dental material
Nano resin compositeOther
Dental composite material
| Study group | Role | What they receive |
|---|---|---|
| Nano resin composite | Active comparator | are types of synthetic resins which are used in dentistry as restorative material or adhesives. Receives: Other: Bulk fill composite; Other: Nano resin composite |
| Bulk fill composite | Experimental | Bulk- ll composites are claimed to be restorative materials used in deep preparations and effectively photoactivated in layers up to 4 mm. Receives: Other: Bulk fill composite; Other: Nano resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity
post operative sensitivity
Measured: one month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start1 Sep 2016
- Primary completion3 Sep 2016
- Study completion25 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- bulk fill resin composite placement techqniues versus nano resin composite at postoperative hypersensitivity
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rasmia Mamdouh Ali Salem
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Sponsor-investigator, Rasmia Mamdouh Ali Salem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792178
- Sponsor's protocol ID
- 150405
- Acronym
- EPSBN
- Status last verified
- Jan 2019
- First submitted
- 1 Jan 2019
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-operative Sensitivity of Bulk Fill Resin Composite Versus the Nano Resin Composite.
- ClinicalTrials.gov ID
- NCT03792178
- Acronym / sponsor ID
- EPSBN / 150405
- Conditions
- Sensitivity
- Keywords
- Post operative sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rasmia Mamdouh Ali SalemUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 3 Sep 2016 (actual)
- Study completion
- 25 Apr 2017 (actual)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study evaluated and compared the postoperative sensitivity of the placement technique (incremental and bulk fill) in class II posterior composite resin restorations bonded with two different adhesive strategies (self-etch and etch-and-rinse).Sixty patients were randomly selected, their age range from 25 to 40 years old. They were divided into 2 main groups according to the packing technique of composite material; incremental Tetric Evoceram and Tetric Evoceram bulk fill composite.30 patients (n=30) were selected for incremental Tetric Evoceram composite restorations and they were equally divided according to the adhesive systems used (etch and rinse or self-etch adhesive strategy) (n=15 teeth).30 patients (n=30) were selected for Tetric Evoceram bulk fill composite restorations and they were equally divided according to the adhesive systems used (etch and rinse or self-etch adhesive strategy) (n=15 teeth).Post-operative pain assessed at 24 hours, 1 week and 1 month using the visual Analog Scale Score (VAS).Each patient was instructed to place a vertical mark on the VAS line at home to indicate the intensity of pain at each assessment period.
Detailed description
Our results revealed that when the two composite types using self-etch adhesive system \& total-etch adhesive system were evaluated; there was no statistically significant difference between the two composite types after 1 day, 1 week as well as 1 month.
When the two adhesive systems were compared using Bulk Fill composite \& incremental Nano resin composite there was no statistically significant difference between the two adhesive systems after 1 day, 1 week as well as 1 month.
Using Bulk Fill composite with self-etch adhesive; there was a statistically significant decrease in prevalence of hypersensitivity after 1 week. There were no cases with hypersensitivity after 1 week as well as 1 month. Using Bulk Fill composite with Total etch adhesive; there was a statistically significant decrease in prevalence of hypersensitivity after 1 week as well as from 1 week to 1 month.
Using Incremental Nano resin composite with self-etch adhesive; there was a statistically significant decrease in prevalence of hypersensitivity after 1 week as well as from 1 week to 1 month. Using Incremental Nano resin composite with Total etch adhesive; there was a statistically significant decrease in prevalence of hypersensitivity after 1 week as well as from 1 week to 1 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- bulk fill resin composite placement techqniues versus nano resin composite at postoperative hypersensitivity
| Arm | Type | Receives |
|---|---|---|
| Nano resin composite | Active comparator | Other: Bulk fill composite, Other: Nano resin compositeare types of synthetic resins which are used in dentistry as restorative material or adhesives. |
| Bulk fill composite | Experimental | Other: Bulk fill composite, Other: Nano resin compositeBulk- ll composites are claimed to be restorative materials used in deep preparations and effectively photoactivated in layers up to 4 mm. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients must show no signs of spontaneous dental or orofacial pain.
- The presence of molar and premolar class II teeth requiring composite restorations for the treatment of primary carious lesions
- The selected teeth should have an occlusal contact with natural or crowned antagonist teeth
- The selected teeth should have a proximal contact with the adjacent teeth.
- Shallow and mid-sized cavity depths will be included in the study .
Key exclusion criteria (7 listed)
- Increasing pre-operative sensitivity of the selected teeth.
- Teeth with abnormal periapical anatomy or caries that will be likely to result in very deep restorations.
- Teeth with old restorations or severely destructed dental crowns.
- Teeth with spontaneous pain
- Tempro-mandibular joint problems involving symptomatic pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bulk fill compositeComposite resin dental material | Other | Bulk fill composite, Nano resin composite |
| Nano resin compositeDental composite material | Other | Bulk fill composite, Nano resin composite |
Primary outcome
sensitivity
Time frame: one month follow up
post operative sensitivity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bulk fill composite and Nano resin composite in people with Sensitivity, run by Rasmia Mamdouh Ali Salem.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity (time frame: one month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.