Occlusal CariesPhase 1NCT04463342
Evaluation of Clinical Performance for Recent Non Coated Glass Ionomer in Posterior Teeth
A Phase 1 study testing Non Coated Glass Ionomer and Conventional Glass Ionomer with Coat in people with Occlusal Caries, run by Cairo University at 1 site in Egypt.
Trial summary
In patients with occlusal caries in posterior teeth, does the use of recently introduced non coated glass ionomer provide better clinical performance compared to conventional glass ionomer with surface coating? -Primary objective: To evaluate clinical performance of different types of restorations (Ketac molar with… Read more about this study
- Who is it for?
- Ages 19 to 40 years
- Conditions the study is for
- Occlusal Caries
- What is being tested?
- Non Coated Glass Ionomer and Conventional Glass Ionomer with Coat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Sep 2019to 10 Feb 2021
- Phase
- Phase 1
- 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 19 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of at least 2 carious class I in same patient.
- The absence of tooth mobility.
- Presence of contact with opposite teeth without any abnormal occlusion stress for the selected teeth.
- Accessible isolation and observable and easily accessible.
Who cannot join
- Patients with poor oral hygiene. According to DMF or ADA criteria.
- The presence of any para functional habit.
- Abnormal occlusion.
- Any regurgitation problem.
- Subjects with compromised medical history.
- Pulpitis, non-vital or endodontically treated teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Clinical Performance for Recently Introduced Non Coated Glass Ionomer in Occlusal Caries in Posterior Teeth Compared to Conventional Glass Ionomer With Coating: A Randomized Clinical Trial
In patients with occlusal caries in posterior teeth, does the use of recently introduced non coated glass ionomer provide better clinical performance compared to conventional glass ionomer with surface coating?
-Primary objective: To evaluate clinical performance of different types of restorations (Ketac molar with coating and Ketac Universal Aplicap 3M without coating) in occlusal caries in posterior teeth.
Read the detailed description
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Mahmoud Magdy Eldamanhory
Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University
- Local anesthesia will be applied to patients complaining about pain or sensitivity to prevent discomfort during restorative procedures.
- Conservative cavity design will be used according to the principals of minimal invasive dentistry.
- All the cavities will be performed by the main author using #57 straight plain carbide fissure bur held in high speed contra-angled hand piece with water cooling system.
- All internal line angles will be slightly rounded.
- Each bur will be discarded after 5 preparations
- If deep caries will be found, it will be removed with large round bur at low speed and a thin layer of calcium hydroxide will be placed on the deep portion of the cavity.
- Isolation will be maintained by using Rubber Dam.
- The dentin and enamel of cavities will be conditioned with 20% polyacrylic acid for 20 seconds (Cavity Conditioner, GC), washed, and briefly dried.
- The restorations will inject into the cavity.
- After the passage of the manufacturer's recommended setting time of 2.5 minutes, the restoration will be trimmed and polished wet using high-speed fine diamonds.
In control group ketac molar with coating:
-After the restoration will briefly dry, Ketac Coat will be applied and photocured for 20 seconds using a photo-curing light.
In study group " Ketac Universal Aplicap 3M without coating":
-The newest addition to glass ionomer family, Ketac Universal Aplicap glass ionomer restorative is a self-cure, one-step placement material designed to help to finish faster. There's no need for conditioning, coating or light-curing steps.
- Conditions
- Occlusal Caries
- Being tested
- Non Coated Glass Ionomer, Conventional Glass Ionomer with Coat
- Keywords
- Occlusal Caries, Glass Ionomer, Tooth colored Restoration, Non-Coated Glass Ionomer, Universal Glass Ionomer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Coated Glass IonomerCombination product
Also called Ketac Universal Aplicap- Glass Ionomer Restorative
KetacTM Universal AplicapTM Glass Ionomer Restorative saves time by eliminating the need for a coating-yet still delivers the compressive strength and surface hardness that are higher than several competitive glass ionomers which require one.
Conventional Glass Ionomer with CoatCombination product
Conventional Glass Ionomer with Coat
| Study group | Role | What they receive |
|---|---|---|
| Non Coated Glass Ionomer | Experimental | A faster, easier procedure is great, but you want assurance that reducing chair time doesn't mean compromising on performance. KetacTM Universal AplicapTM Glass Ionomer Restorative saves time by eliminating the need for a coating-yet still delivers the compressive strength and surface hardness that are higher than several competitive glass ionomers which require one.This advancement is the latest in 3M's 30-year history of developing proven and trusted glass ionomers. Receives: Combination Product: Non Coated Glass Ionomer |
| Conventional Glass Ionomer with Coat | Active comparator | A bulk-fill, packable and fast-setting conventional glass ionomer. Because it's less "technique sensitive" than a composite it's ideal for difficult-to-isolate posterior restoration. High compressive strength and marginal integrity make it a glass ionomer of choice for posterior restorations.Ketac Conditioner Dentin Pretreatment is required; Ketac Glaze Light-Cured Varnish applied on the top of the restoration to avoid moisture contamination. Receives: Combination Product: Conventional Glass Ionomer with Coat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance penetrated by the Explorer at the tooth restoration interface
The explorer will be drawn across the surface of the restoration toward the tooth
Measured: during procedure
Distance penetrated by the Explorer at the tooth restoration interface
The explorer will be drawn across the surface of the restoration toward the tooth
Measured: 3 months
Distance penetrated by the Explorer at the tooth restoration interface
The explorer will be drawn across the surface of the restoration toward the tooth
Measured: 6 months
Distance penetrated by the Explorer at the tooth restoration interface
The explorer will be drawn across the surface of the restoration toward the tooth
Measured: 12 months
The degree of mismatch from the normal range of tooth shades and translucency
Visual inspection to check the proximity of the shade from the natural tooth
Measured: during procedure
The degree of mismatch from the normal range of tooth shades and translucency
Visual inspection to check the proximity of the shade from the natural tooth
Measured: 3 months
The degree of mismatch from the normal range of tooth shades and translucency
Visual inspection to check the proximity of the shade from the natural tooth
Measured: 6 months
The degree of mismatch from the normal range of tooth shades and translucency
Visual inspection to check the proximity of the shade from the natural tooth
Measured: 12 months
Distance penetrated along the restoration in a pulpal direction
Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure
Measured: during procedure
Distance penetrated along the restoration in a pulpal direction
Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure
Measured: 3 months
Distance penetrated along the restoration in a pulpal direction
Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure
Measured: 6 months
Distance penetrated along the restoration in a pulpal direction
Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure
Measured: 12 months
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Measured: during procedure
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Measured: 3 months
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Measured: 6 months
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Measured: 12 months
Area of continuous movement of an explorer across the surface of the restoration
Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
Measured: during procedure
Area of continuous movement of an explorer across the surface of the restoration
Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
Measured: 3 months
Area of continuous movement of an explorer across the surface of the restoration
Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
Measured: 6 months
Area of continuous movement of an explorer across the surface of the restoration
Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
Measured: 12 months
Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.
Visual inspection and explorer to check the shape and structure of the restoration
Measured: during procedure
Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.
Visual inspection and explorer to check the shape and structure of the restoration
Measured: 3 months
Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.
Visual inspection and explorer to check the shape and structure of the restoration
Measured: 6 months
Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.
Visual inspection and explorer to check the shape and structure of the restoration
Measured: 12 months
Pain due to dentin hypersensitivity (evaporative stimulus)
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
Measured: during procedure
Pain due to dentin hypersensitivity (evaporative stimulus)
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
Measured: 3 months
Pain due to dentin hypersensitivity (evaporative stimulus)
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
Measured: 6 months
Pain due to dentin hypersensitivity (evaporative stimulus)
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start3 Sep 2019
- Primary completion10 Jan 2020
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occlusal CariesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Occlusal Caries in Posterior teeth
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Magdy Eldamanhoury, Cairo University
- Investigators
- Mahmoud M Eldamanhoury, Master, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463342
- Sponsor's protocol ID
- CairoU-MMEldamanhoury
- Status last verified
- Mar 2025
- First submitted
- 24 Jun 2020
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Performance for Recently Introduced Non Coated Glass Ionomer in Occlusal Caries in Posterior Teeth Compared to Conventional Glass Ionomer With Coating: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04463342
- Acronym / sponsor ID
- CairoU-MMEldamanhoury
- Conditions
- Occlusal Caries
- Keywords
- Occlusal Caries, Glass Ionomer, Tooth colored Restoration, Non-Coated Glass Ionomer, Universal Glass Ionomer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 9 Jul 2020 (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.
In patients with occlusal caries in posterior teeth, does the use of recently introduced non coated glass ionomer provide better clinical performance compared to conventional glass ionomer with surface coating?
-Primary objective: To evaluate clinical performance of different types of restorations (Ketac molar with coating and Ketac Universal Aplicap 3M without coating) in occlusal caries in posterior teeth.
Detailed description
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Mahmoud Magdy Eldamanhory
Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University
- Local anesthesia will be applied to patients complaining about pain or sensitivity to prevent discomfort during restorative procedures.
- Conservative cavity design will be used according to the principals of minimal invasive dentistry.
- All the cavities will be performed by the main author using #57 straight plain carbide fissure bur held in high speed contra-angled hand piece with water cooling system.
- All internal line angles will be slightly rounded.
- Each bur will be discarded after 5 preparations
- If deep caries will be found, it will be removed with large round bur at low speed and a thin layer of calcium hydroxide will be placed on the deep portion of the cavity.
- Isolation will be maintained by using Rubber Dam.
- The dentin and enamel of cavities will be conditioned with 20% polyacrylic acid for 20 seconds (Cavity Conditioner, GC), washed, and briefly dried.
- The restorations will inject into the cavity.
- After the passage of the manufacturer's recommended setting time of 2.5 minutes, the restoration will be trimmed and polished wet using high-speed fine diamonds.
In control group ketac molar with coating:
-After the restoration will briefly dry, Ketac Coat will be applied and photocured for 20 seconds using a photo-curing light.
In study group " Ketac Universal Aplicap 3M without coating":
-The newest addition to glass ionomer family, Ketac Universal Aplicap glass ionomer restorative is a self-cure, one-step placement material designed to help to finish faster. There's no need for conditioning, coating or light-curing steps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Occlusal Caries in Posterior teeth
| Arm | Type | Receives |
|---|---|---|
| Non Coated Glass Ionomer | Experimental | Combination Product: Non Coated Glass IonomerA faster, easier procedure is great, but you want assurance that reducing chair time doesn't mean compromising on performance. KetacTM Universal AplicapTM Glass Ionomer Restorative saves time by eliminating the need for a coating-yet still delivers the compressive strength and surface hardness that are higher than several competitive glass ionomers which require one.This advancement is the latest in 3M's 30-year history of developing proven and trusted glass ionomers. |
| Conventional Glass Ionomer with Coat | Active comparator | Combination Product: Conventional Glass Ionomer with CoatA bulk-fill, packable and fast-setting conventional glass ionomer. Because it's less "technique sensitive" than a composite it's ideal for difficult-to-isolate posterior restoration. High compressive strength and marginal integrity make it a glass ionomer of choice for posterior restorations.Ketac Conditioner Dentin Pretreatment is required; Ketac Glaze Light-Cured Varnish applied on the top of the restoration to avoid moisture contamination. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Presence of at least 2 carious class I in same patient.
- The absence of tooth mobility.
- Presence of contact with opposite teeth without any abnormal occlusion stress for the selected teeth.
- Accessible isolation and observable and easily accessible.
Key exclusion criteria (6 listed)
- Patients with poor oral hygiene. According to DMF or ADA criteria.
- The presence of any para functional habit.
- Abnormal occlusion.
- Any regurgitation problem.
- Subjects with compromised medical history.
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 |
|---|---|---|
| Non Coated Glass IonomerAlso: Ketac Universal Aplicap- Glass Ionomer RestorativeKetacTM Universal AplicapTM Glass Ionomer Restorative saves time by eliminating the need for a coating-yet still delivers the compressive strength and surface hardness that are higher than several competitive glass ionomers which require one. | Combination product | Non Coated Glass Ionomer |
| Conventional Glass Ionomer with CoatConventional Glass Ionomer with Coat | Combination product | Conventional Glass Ionomer with Coat |
Primary outcome
Distance penetrated by the Explorer at the tooth restoration interface
Time frame: during procedure
The explorer will be drawn across the surface of the restoration toward the tooth
Distance penetrated by the Explorer at the tooth restoration interface
Time frame: 3 months
The explorer will be drawn across the surface of the restoration toward the tooth
Distance penetrated by the Explorer at the tooth restoration interface
Time frame: 6 months
The explorer will be drawn across the surface of the restoration toward the tooth
Distance penetrated by the Explorer at the tooth restoration interface
Time frame: 12 months
The explorer will be drawn across the surface of the restoration toward the tooth
The degree of mismatch from the normal range of tooth shades and translucency
Time frame: during procedure
Visual inspection to check the proximity of the shade from the natural tooth
The degree of mismatch from the normal range of tooth shades and translucency
Time frame: 3 months
Visual inspection to check the proximity of the shade from the natural tooth
The degree of mismatch from the normal range of tooth shades and translucency
Time frame: 6 months
Visual inspection to check the proximity of the shade from the natural tooth
The degree of mismatch from the normal range of tooth shades and translucency
Time frame: 12 months
Visual inspection to check the proximity of the shade from the natural tooth
Distance penetrated along the restoration in a pulpal direction
Time frame: during procedure
Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure
Distance penetrated along the restoration in a pulpal direction
Time frame: 3 months
Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure
Distance penetrated along the restoration in a pulpal direction
Time frame: 6 months
Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure
Distance penetrated along the restoration in a pulpal direction
Time frame: 12 months
Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Time frame: during procedure
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Time frame: 3 months
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Time frame: 6 months
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Time frame: 12 months
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Area of continuous movement of an explorer across the surface of the restoration
Time frame: during procedure
Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
Area of continuous movement of an explorer across the surface of the restoration
Time frame: 3 months
Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
Area of continuous movement of an explorer across the surface of the restoration
Time frame: 6 months
Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
Area of continuous movement of an explorer across the surface of the restoration
Time frame: 12 months
Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.
Time frame: during procedure
Visual inspection and explorer to check the shape and structure of the restoration
Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.
Time frame: 3 months
Visual inspection and explorer to check the shape and structure of the restoration
Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.
Time frame: 6 months
Visual inspection and explorer to check the shape and structure of the restoration
Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.
Time frame: 12 months
Visual inspection and explorer to check the shape and structure of the restoration
Pain due to dentin hypersensitivity (evaporative stimulus)
Time frame: during procedure
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
Pain due to dentin hypersensitivity (evaporative stimulus)
Time frame: 3 months
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
Pain due to dentin hypersensitivity (evaporative stimulus)
Time frame: 6 months
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
Pain due to dentin hypersensitivity (evaporative stimulus)
Time frame: 12 months
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
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 26 Mar 2025.
- Individual participant dataSharing planned: Yes. Undecided: It is not yet known if there will be a plan to make IPD available.
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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.
Mahmoud M Eldamanhoury, Master principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Non Coated Glass Ionomer and Conventional Glass Ionomer with Coat in people with Occlusal Caries, 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 4 inclusion and 6 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 26 Mar 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Distance penetrated by the Explorer at the tooth restoration interface (time frame: during procedure). The study lists 28 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 26 Mar 2025.