Teeth SensitivityNCT06622018
Effect of Seashell Nanoparticles and Gluma Desensitizer on Sensitivity of Teeth
A study testing Seashell Nanoparticles and Gluma Desensitizer in people with Teeth Sensitivity and Treated Dentin Surfaces, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
Tooth hypersensitivity is characterized by a transient short and sharp pain originating from exposed dentin in response to thermal, dehydrating, tactile, osmotic, and chemical stimuli. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Teeth Sensitivity, Treated Dentin Surfaces
- What is being tested?
- Seashell Nanoparticles and Gluma Desensitizer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2023to 10 Oct 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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- For patient Age between 25 and 40 years and no gender reference.
- For the teeth Absence of pulpal exposure, RCT treatments, fracture and free of extensive caries (The amount of caries that can be removed during the preparation is acceptable
Who cannot join
- -For patients Use of desensitizing substances or drug like antihistamines, antidepressant 6 weeks before or during the study.
- Requiring antibiotic prophylaxes or cortico-steriod therapy.
- -For teeth Tooth hypersensitivity prior to tooth preparation (like, abrasion or attration).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Seashell Nanoparticles and Gluma Desensitizer on Sensitivity of Teeth Prepared for Intra Coronal Restorations as Well as Micromorphology of The Treated Dentin Surfaces
Tooth hypersensitivity is characterized by a transient short and sharp pain originating from exposed dentin in response to thermal, dehydrating, tactile, osmotic, and chemical stimuli. Tooth sensitivity after cementation of complete coverage crowns, is a rather common event since much of the protecting enamel is removed during preparation and a large area of dentin is exposed.
Dentin contains up to two million tubules per cm2, which corresponds approximately to the surface area of most crown preparations. It is well known that such dentin wounds respond to mechanical, osmotic, or thermal stimulation with pain. This phenomenon is commonly example by the hydrodynamic theory of Brannstrom.
Read the detailed description
The extent and duration of post cementation hypersensitivity has been related to number of factors, mainly associated with preparation trauma. However, research reports confirm potential effects of luting agents used and leakage of bacteria and bacterial products from the oral cavity along the margins of restorations, especially as a response to poorly fitting temporary restorations. Apparently, a relationship exists between the time interval during which the temporary restoration is in place and post cementation sensitivity.
Gluma Desensitizer is a combination of glutaraldehyde and HEMA (Hydroxy Ethyl Methacrylate). Glutaraldehyde causes amino acids and proteins to coagulate in dentinal tubules and is an effective disinfectant. HEMA can be effective in sealing of dentinal tubules.
Gluma does not interfere with dentin bonding systems but its glutaraldehyde component can damage the gingiva after long term exposure. HEMA can cause contact dermatitis and it can actually perforate latex gloves and must be used with caution, hence, the use of rubber dam is advised in such cases .
HEMA is soluble in water allowing it to penetrate deep into dentinal tubules however, the effect is reversible and HEMA gradually loses its effect allowing the dentinal tubules to again became exposed.
Hydroxyapatite powder is one such material that exhibits excellent bioactive properties and striking similarities to dental hard tissues can be achieved from two different sources. Synthetic and natural (biologic) hydroxyapatite.HAP can be produced from Coral Seashells, eggshells and also from body fluids.
Recently, the use of waste materials to synthesize HAP has received great response from many researchers across the world. This idea gives an innovation to produce a new valuable product from the waste materials such as seashell.Seashell consists of high source of calcium that can act as calcium precursor. Some researcher found that the content of calcium carbonate (CaCO3) in seashell is approximately between 98 and 99 %.
The word seashell is often used to mean only the shell of a marine mollusk. Using seashell as source of calcium carbonate (CaCO3) to produce calcite nanoparticle is meaningful for both environmental protection and biomedical application. Seashell is with the natural ceramic structure are similar to human bone and tooth structure.
The conversation of macroparticles into nanoparticles resulted in larger surface area increasing the reactivity of nanoparticles and hence, it's efficacy. Nanoparticles have widespread use due to their superior properties and are being investigated extensively in recent years due to their advantages.Nano -sized materials can enter dentinal tubules of 2 -3 µm in diameter, easily occluding the dentinal tubules
- Conditions
- Teeth Sensitivity, Treated Dentin Surfaces
- Being tested
- Seashell Nanoparticles and 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.
Seashell Nanoparticles and Gluma DesensitizerProcedure or surgery
Also called Micromorphology
Evaluation the effect of Seashell Nano Particles and Gluma desensitizer on sensitivity of the teeth for Intra coronal restoration at different times
| Study group | Role | What they receive |
|---|---|---|
| Group A (Control Group) | Placebo comparator | About 11 patients with hypersensitive teeth of no treatment materials used Receives: Procedure: Seashell Nanoparticles and Gluma Desensitizer |
| Group B(Seashell Nanoparticles Group) | Active comparator | About 11 patients with hypersensitive teeth faced treatment by sea shell nanoparticles Receives: Procedure: Seashell Nanoparticles and Gluma Desensitizer |
| Group C (Gluma Group) | Active comparator | About 11 patients with hypersensitive teeth faced treatment by Gluma Receives: Procedure: Seashell Nanoparticles and Gluma Desensitizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desnsetizing agent Hypersensitivity
Evaluation of the treated patients from hypersensitivity of the application of desnsetizing agent ( gluma and nanasaesheall) by using VAS score (from 0 to 10) as 0 is mean no sensitivity while 10 is the worst.
Measured: from 0 hours to two weeks
Secondary outcomes (1)
Dentinal tubule occlusion
Ability of the materials to induce dentinal tubule occlusion using SEM
Measured: from 0 hours to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Jan 2023
- Primary completion5 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teeth 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
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Collaborators
- Al-Azhar University
- Responsible party
- Principal investigator, Hoda Fathy El gendy, Faculty of Dental Medicine for Girls
- Investigators
- Osama Saleh Abd El Ghani, Professor, Study chair, Al-Azhar Faculty of Dental Medicine for girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622018
- Sponsor's protocol ID
- Hoda El Gendy
- Status last verified
- Jan 2023
- First submitted
- 28 Sep 2024
- Last updated
- 1 Oct 2024
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Seashell Nanoparticles and Gluma Desensitizer on Sensitivity of Teeth Prepared for Intra Coronal Restorations as Well as Micromorphology of The Treated Dentin Surfaces
- ClinicalTrials.gov ID
- NCT06622018
- Acronym / sponsor ID
- Hoda El Gendy
- Conditions
- Teeth Sensitivity, Treated Dentin Surfaces
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Collaborators
- Al-Azhar University
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 1 Oct 2024 (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.
Tooth hypersensitivity is characterized by a transient short and sharp pain originating from exposed dentin in response to thermal, dehydrating, tactile, osmotic, and chemical stimuli. Tooth sensitivity after cementation of complete coverage crowns, is a rather common event since much of the protecting enamel is removed during preparation and a large area of dentin is exposed.
Dentin contains up to two million tubules per cm2, which corresponds approximately to the surface area of most crown preparations. It is well known that such dentin wounds respond to mechanical, osmotic, or thermal stimulation with pain. This phenomenon is commonly example by the hydrodynamic theory of Brannstrom.
Detailed description
The extent and duration of post cementation hypersensitivity has been related to number of factors, mainly associated with preparation trauma. However, research reports confirm potential effects of luting agents used and leakage of bacteria and bacterial products from the oral cavity along the margins of restorations, especially as a response to poorly fitting temporary restorations. Apparently, a relationship exists between the time interval during which the temporary restoration is in place and post cementation sensitivity.
Gluma Desensitizer is a combination of glutaraldehyde and HEMA (Hydroxy Ethyl Methacrylate). Glutaraldehyde causes amino acids and proteins to coagulate in dentinal tubules and is an effective disinfectant. HEMA can be effective in sealing of dentinal tubules.
Gluma does not interfere with dentin bonding systems but its glutaraldehyde component can damage the gingiva after long term exposure. HEMA can cause contact dermatitis and it can actually perforate latex gloves and must be used with caution, hence, the use of rubber dam is advised in such cases .
HEMA is soluble in water allowing it to penetrate deep into dentinal tubules however, the effect is reversible and HEMA gradually loses its effect allowing the dentinal tubules to again became exposed.
Hydroxyapatite powder is one such material that exhibits excellent bioactive properties and striking similarities to dental hard tissues can be achieved from two different sources. Synthetic and natural (biologic) hydroxyapatite.HAP can be produced from Coral Seashells, eggshells and also from body fluids.
Recently, the use of waste materials to synthesize HAP has received great response from many researchers across the world. This idea gives an innovation to produce a new valuable product from the waste materials such as seashell.Seashell consists of high source of calcium that can act as calcium precursor. Some researcher found that the content of calcium carbonate (CaCO3) in seashell is approximately between 98 and 99 %.
The word seashell is often used to mean only the shell of a marine mollusk. Using seashell as source of calcium carbonate (CaCO3) to produce calcite nanoparticle is meaningful for both environmental protection and biomedical application. Seashell is with the natural ceramic structure are similar to human bone and tooth structure.
The conversation of macroparticles into nanoparticles resulted in larger surface area increasing the reactivity of nanoparticles and hence, it's efficacy. Nanoparticles have widespread use due to their superior properties and are being investigated extensively in recent years due to their advantages.Nano -sized materials can enter dentinal tubules of 2 -3 µm in diameter, easily occluding the dentinal tubules
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Control Group) | Placebo comparator | Procedure: Seashell Nanoparticles and Gluma DesensitizerAbout 11 patients with hypersensitive teeth of no treatment materials used |
| Group B(Seashell Nanoparticles Group) | Active comparator | Procedure: Seashell Nanoparticles and Gluma DesensitizerAbout 11 patients with hypersensitive teeth faced treatment by sea shell nanoparticles |
| Group C (Gluma Group) | Active comparator | Procedure: Seashell Nanoparticles and Gluma DesensitizerAbout 11 patients with hypersensitive teeth faced treatment by Gluma |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- For patient Age between 25 and 40 years and no gender reference.
- For the teeth Absence of pulpal exposure, RCT treatments, fracture and free of extensive caries (The amount of caries that can be removed during the preparation is acceptable
Key exclusion criteria (3 listed)
- -For patients Use of desensitizing substances or drug like antihistamines, antidepressant 6 weeks before or during the study.
- Requiring antibiotic prophylaxes or cortico-steriod therapy.
- -For teeth Tooth hypersensitivity prior to tooth preparation (like, abrasion or attration).
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 |
|---|---|---|
| Seashell Nanoparticles and Gluma DesensitizerAlso: MicromorphologyEvaluation the effect of Seashell Nano Particles and Gluma desensitizer on sensitivity of the teeth for Intra coronal restoration at different times | Procedure or surgery | Group A (Control Group), Group B(Seashell Nanoparticles Group), Group C (Gluma Group) |
Primary outcome
Desnsetizing agent Hypersensitivity
Time frame: from 0 hours to two weeks
Evaluation of the treated patients from hypersensitivity of the application of desnsetizing agent ( gluma and nanasaesheall) by using VAS score (from 0 to 10) as 0 is mean no sensitivity while 10 is the worst.
1 secondary outcome
Dentinal tubule occlusion
Time frame: from 0 hours to two weeks
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 1 Oct 2024.
- 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.
Osama Saleh Abd El Ghani, Professor study chair
Al-Azhar Faculty of Dental Medicine for girls
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seashell Nanoparticles and Gluma Desensitizer in people with Teeth Sensitivity and Treated Dentin Surfaces, run by Faculty of Dental Medicine for Girls 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 2 inclusion and 3 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 1 Oct 2024. 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. Some participants in this study may receive a placebo. 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?
Desnsetizing agent Hypersensitivity (time frame: from 0 hours to two weeks). 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 1 Oct 2024.