Dentin HypersensitivityNCT06113874
The Influence of Desensitizing Agent on Postoperative Sensitivity in Posterior Composite Restoration
A study testing Hurriseal desensitizer and Gluma desensitizer in people with Dentin Hypersensitivity, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
This study aims to investigate the influence of desensitizing agents on reducing post-operative sensitivity in posterior composite. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Hurriseal desensitizer and Gluma desensitizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2022to 30 Aug 2023
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients having active primary class I carious lesions on vital molar teeth either in the middle or the inner third of dentin in the three quadrants of each patients.
- Teeth having a positive reaction to vitality test (cold test), no signs of pulp inflammation, or spontaneous pain before treatment.
- Preoperative radiographic record of the carious lesions.
- Buccolingual width is no more than half the inter-cuspal distance
Who cannot join
- Excessive tooth wear due to clenching or abnormal habits.
- Patients with direct occlusal contact by antagonist cusp (traumatic occlusion).
- Patients with periodontal or gingival disease.
- Patients using analgesics and/or anti-inflammatory medicine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Desensitizing Agent on Postoperative Sensitivity in Posterior Composite Restoration: A Randomized Controlled Clinical Trial
This study aims to investigate the influence of desensitizing agents on reducing post-operative sensitivity in posterior composite.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Hurriseal desensitizer, Gluma desensitizer
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hurriseal desensitizerOther
Patients will receive Hurriseal desensitizing agent and universal bond and composite.
Cavities will be restored with light-cured composite resin following the application of bonding agent.
Gluma desensitizerOther
Patients will receive Gluma desensitizing agent and universal bond and composite.
Cavities will be restored with light-cured composite resin following the application of bonding agent.
| Study group | Role | What they receive |
|---|---|---|
| Composite with Hurriseal desensitizer | Experimental | Not described Receives: Other: Hurriseal desensitizer |
| Composite with Gluma Desensitizer | Active comparator | Not described Receives: Other: Gluma desensitizer |
| Composite without desensitizer | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypersensitivity assessment
Air spray will be applied from a 2-mm distance on to the occlusal for 3 seconds. The severity of patients' pain/sensitivity will be recorded using (0-10) numerical rating scale. The score will be ranged from 0 (No pain) to 10 (maximum pain)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start5 Jul 2022
- Primary completion5 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin HypersensitivityStudies 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
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Nessrin Magdy, BDS, Principal investigator, Alexandria UniversityWaleed El-Mahy, PhD, Study director, Alexandria UniversityRania R Afifi, PhD, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113874
- Sponsor's protocol ID
- 7/22
- Status last verified
- Oct 2023
- First submitted
- 27 Oct 2023
- Last updated
- 2 Nov 2023
- 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 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Desensitizing Agent on Postoperative Sensitivity in Posterior Composite Restoration: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06113874
- Acronym / sponsor ID
- 7/22
- Conditions
- Dentin Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 2 Nov 2023 (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.
This study aims to investigate the influence of desensitizing agents on reducing post-operative sensitivity in posterior composite.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Composite with Hurriseal desensitizer | Experimental | Other: Hurriseal desensitizer |
| Composite with Gluma Desensitizer | Active comparator | Other: Gluma desensitizer |
| Composite without desensitizer | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients having active primary class I carious lesions on vital molar teeth either in the middle or the inner third of dentin in the three quadrants of each patients.
- Teeth having a positive reaction to vitality test (cold test), no signs of pulp inflammation, or spontaneous pain before treatment.
- Preoperative radiographic record of the carious lesions.
- Buccolingual width is no more than half the inter-cuspal distance
Key exclusion criteria (4 listed)
- Excessive tooth wear due to clenching or abnormal habits.
- Patients with direct occlusal contact by antagonist cusp (traumatic occlusion).
- Patients with periodontal or gingival disease.
- Patients using analgesics and/or anti-inflammatory medicine.
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 |
|---|---|---|
| Hurriseal desensitizerPatients will receive Hurriseal desensitizing agent and universal bond and composite. Cavities will be restored with light-cured composite resin following the application of bonding agent. | Other | Composite with Hurriseal desensitizer |
| Gluma desensitizerPatients will receive Gluma desensitizing agent and universal bond and composite. Cavities will be restored with light-cured composite resin following the application of bonding agent. | Other | Composite with Gluma Desensitizer |
Primary outcome
Hypersensitivity assessment
Time frame: up to 12 months
Air spray will be applied from a 2-mm distance on to the occlusal for 3 seconds. The severity of patients' pain/sensitivity will be recorded using (0-10) numerical rating scale. The score will be ranged from 0 (No pain) to 10 (maximum pain)
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 2 Nov 2023.
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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.
Nessrin Magdy, BDS principal investigator
Alexandria University
Waleed El-Mahy, PhD study director
Alexandria University
Rania R Afifi, PhD study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hurriseal desensitizer and Gluma desensitizer in people with Dentin Hypersensitivity, run by Nourhan M.Aly 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 4 inclusion and 4 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 2 Nov 2023. 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?
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?
Hypersensitivity assessment (time frame: up to 12 months). 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 2 Nov 2023.