Hypersensitivity DentinNCT03562858
Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations
A study testing Immediate dentin sealing protocol and Delayed dentin sealing protocol in people with Hypersensitivity Dentin, run by Cairo University at 1 site in Egypt.
Trial summary
PICOT elements:P: Teeth restored with indirect tooth colored restoration I: Immediate dentin sealing using universal adhesive C: Delayed dentin sealing O: Post-operative Hypersensitivity T: -Hypersensitivity assessment one week during provisionalization period and post-cementation S: Randomized Controlled Clinical… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersensitivity Dentin
- What is being tested?
- Immediate dentin sealing protocol and Delayed dentin sealing protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2018to Oct 2018
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Extensive carious lesions indicated for indirect restorations
- Lower first molars
- Age of patients range is 18 -50 years
- Patients have not received antibiotic therapy for 1 month before sampling
- Males or Females (Both genders)
- Patients with Good oral hygiene
- Co-operative patients approving the trial
Who cannot join
- Pregnancy
- Systemic disease or severe medical
- Patients having complications as:
- Periodontal problems Mobile teeth, arrest caries and non-vital teeth
- Heavy smoking patients
- Xerostomia
- Lack of compliance
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry cairo university
Cairo, 002
Hoda Fouda, 01003786531, Hoda.omar@dentiatry.cu.edu.eg
Hoda Fouda, Master
About this study
Official title: Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations: Randomized Controlled Clinical Trial
PICOT elements:P: Teeth restored with indirect tooth colored restoration I: Immediate dentin sealing using universal adhesive C: Delayed dentin sealing O: Post-operative Hypersensitivity T: -Hypersensitivity assessment one week during provisionalization period and post-cementation S: Randomized Controlled Clinical Trial
- Conditions
- Hypersensitivity Dentin
- Being tested
- Immediate dentin sealing protocol, Delayed dentin sealing protocol
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate dentin sealing protocolProcedure or surgery
Sealing of the dentin before impression taking directly after cavity preparation to prevent postoperative hypersensitivity during provisionalization and after cementation
Delayed dentin sealing protocolProcedure or surgery
Sealing the dentin just prior to cementation
| Study group | Role | What they receive |
|---|---|---|
| Delayed dentine sealing | Active comparator | Not described Receives: Procedure: Delayed dentin sealing protocol |
| Immediate dentin sealing | Experimental | Not described Receives: Procedure: Immediate dentin sealing protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative hypersensitivity at baseline
The post-operative hypersensitivity assessment will be performed at baseline , using visual analogue scale (VAS) for both intervention and control group . The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity , the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity
Measured: 10 minutes
Post-operative hypersensitivity one week after temporization
The post-operative hypersensitivity will be assessed one week after temporization for both intervention and control group using the visual analogue scale VAS .The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity , the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity
Measured: 1 week
Post-operative hypersensitivity after cementation of the indirect tooth coloured restoration
The post-operative hypersensitivity will be assessed using visual analogue scale VAS 1 week after cementation of the indirect tooth coloured restoration. The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity, the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study startJul 2018 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersensitivity DentinStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hoda omar tawfeek hussien fouda, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562858
- Sponsor's protocol ID
- CEBD-CU-2018-05-21
- Status last verified
- Jun 2018
- First submitted
- 16 May 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03562858
- Acronym / sponsor ID
- CEBD-CU-2018-05-21
- Conditions
- Hypersensitivity Dentin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 20 Jun 2018 (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.
PICOT elements:P: Teeth restored with indirect tooth colored restoration I: Immediate dentin sealing using universal adhesive C: Delayed dentin sealing O: Post-operative Hypersensitivity T: -Hypersensitivity assessment one week during provisionalization period and post-cementation S: Randomized Controlled Clinical Trial
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed dentine sealing | Active comparator | Procedure: Delayed dentin sealing protocol |
| Immediate dentin sealing | Experimental | Procedure: Immediate dentin sealing protocol |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Extensive carious lesions indicated for indirect restorations
- Lower first molars
- Age of patients range is 18 -50 years
- Patients have not received antibiotic therapy for 1 month before sampling
- Males or Females (Both genders)
Key exclusion criteria (7 listed)
- Pregnancy
- Systemic disease or severe medical
- Patients having complications as:
- Periodontal problems Mobile teeth, arrest caries and non-vital teeth
- Heavy smoking patients
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 |
|---|---|---|
| Immediate dentin sealing protocolSealing of the dentin before impression taking directly after cavity preparation to prevent postoperative hypersensitivity during provisionalization and after cementation | Procedure or surgery | Immediate dentin sealing |
| Delayed dentin sealing protocolSealing the dentin just prior to cementation | Procedure or surgery | Delayed dentine sealing |
Primary outcome
Post-operative hypersensitivity at baseline
Time frame: 10 minutes
The post-operative hypersensitivity assessment will be performed at baseline , using visual analogue scale (VAS) for both intervention and control group . The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity , the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity
Post-operative hypersensitivity one week after temporization
Time frame: 1 week
The post-operative hypersensitivity will be assessed one week after temporization for both intervention and control group using the visual analogue scale VAS .The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity , the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity
Post-operative hypersensitivity after cementation of the indirect tooth coloured restoration
Time frame: 1 week
The post-operative hypersensitivity will be assessed using visual analogue scale VAS 1 week after cementation of the indirect tooth coloured restoration. The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity, the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate dentin sealing protocol and Delayed dentin sealing protocol in people with Hypersensitivity Dentin, run by Cairo University at 1 site in Egypt.
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 7 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: status not confirmed, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hoda Fouda, Master (01003786531, Hoda.omar@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative hypersensitivity at baseline (time frame: 10 minutes). The study lists 3 primary outcomes in all. 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 20 Jun 2018.