Dental CariesNCT02071953
Comparative Study of Experimental Dental Adhesive With and Without Phosphoric Acid Pretreatment
A study testing Experimental adhesive w/out phosphoric acid in post. rest. and Experimental adhesive with phosphoric acid in post. rest. in people with Dental Caries, run by Dentsply International.
Trial summary
The intent of this study is to evaluate the clinical performance of an experimental dental bonding agent for use with dental restorative composites with and without pretreatment of the tooth dentin and enamel using phosphoric acid etching. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Experimental adhesive w/out phosphoric acid in post. rest. and Experimental adhesive with phosphoric acid in post. rest.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients in need of Class I and Class II restorations in premolars and molars.
Who cannot join
- Patients with fewer than 20 teeth
- Patients exhibiting poor oral hygiene or uncontrolled periodontal disease
- Pregnant women or lactating mothers
- Patients with known allergies to HEMA or resin-based materials
- Patients with medical conditions that would contraindicate dental treatment
- Patients with xerostomia
About this study
Official title: Clinical Evaluation of an Experimental Universal Adhesive Used With and Without Phosphoric Acid Pretreatment in Posterior Composite Resin Restorations
The intent of this study is to evaluate the clinical performance of an experimental dental bonding agent for use with dental restorative composites with and without pretreatment of the tooth dentin and enamel using phosphoric acid etching.
Read the detailed description
The intent of this study is to evaluate the clinical performance of an experimental dental bonding agent (adhesive) for use with dental restorative composites with and without pretreatment of the tooth dentin and enamel using phosphoric acid etching.
- Conditions
- Dental Caries
- Being tested
- Experimental adhesive w/out phosphoric acid in post. rest., Experimental adhesive with phosphoric acid in post. rest.
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental adhesive w/out phosphoric acid in post. rest.Device
Experimental adhesive without phosphoric acid in posterior restorations
Experimental adhesive with phosphoric acid in post. rest.Device
Experimental adhesive with phosphoric acid in posterior restorations
| Study group | Role | What they receive |
|---|---|---|
| Adhesive without acid pretreatment | Experimental | Experimental adhesive w/out phosphoric acid in post. rest. Receives: Device: Experimental adhesive w/out phosphoric acid in post. rest. |
| Adhesive with acid pretreatment | Active comparator | Experimental adhesive with phosphoric acid in post. rest. Receives: Device: Experimental adhesive with phosphoric acid in post. rest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color Match
The color match will be assessed clinically according to Ryge (1973)* for matching with adjacent teeth and stability of color matching over time.
Assessments will be done to the following criteria:
Alpha= Restoration matches adjacent tooth structure in shade and/or translucency.
Bravo= Mismatch in shade and/or translucency is within normal range of tooth shades.
Charlie= Mismatch in shade and/or translucency is outside normal range of tooth shades.
*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973.
As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Measured: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
Marginal Discoloration
Marginal discoloration will be assessed clinically according to Ryge (1973)* over time.
Assessments will be done to the following criteria:
Alpha= No visual evidence of marginal discoloration. Bravo= Marginal discoloration present but has not penetrated in a pulpal direction.
Charlie= Marginal discoloration has penetrated in a pulpal direction.
*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973.
As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Measured: Baseline, 6 months, 18 months. Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
Marginal Integrity
Change in marginal integrity will be assessed clinically according to Ryge (1973)* over time.
Assessments will be done to the following criteria:
A= Explorer does not catch or slight catch with no visible crevice. B= Explorer catches and crevice is visible but no exposure of dentin or base. C= Explorer penetrates crevice and defect extended to amelo-dentinal junction. D= Restoration is fractured, mobile, or missing in part or in toto.
*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973.
As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Measured: Baseline, 6 months, 18 months. Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
Presence of Secondary Dental Caries (Cavities)
Change in presence of secondary dental caries will be assessed clinically according to Ryge (1973)* over time.
Assessments will be done to the following criteria:
A= No caries present. D= Caries present associated with the restoration.
*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973.
As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Note: Secondary caries is a categorical, dichotomous variable, i.e. there is caries or not. This was assessed clinically and radiographically by a trained professional (dentist).
Measured: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
Presence of Restoration Fractures (Localized or Bulk)
The restoration will be assessed clinically according to Ryge (1973)* for presence of fractures over time.
Assessments will be done to the following criteria:
A= Smooth restoration surface with no irregularities. B= Slightly rough or pitted restoration surface. Can be refinished. C= Deeply pitted or grooved (not related to anatomy) restoration finish. Can not be refinished.
D= Restoration surface is fractured or flaking.
*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973.
As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Measured: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
Post-operative Sensitivity
Patient will be interviewed to assess post-operative sensitivity according to the following criteria:
A= No sensitivity. B= Mild sensitivity. C= Moderate sensitivity with no restoration replacement required. D= Sever sensitivity. Replacement of restoration is required.
Tooth sensitivity will be assessed at baseline and each follow-up appointment using cold thermal test (Endo-Ice, Hygienic) and Electric Pulp Test (EPT) when indicated.
Measured: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
Surface Condition of Restoration
The change in surface condition of restoration will be assessed clinically according to Ryge (1973)* over time.
Assessments will be done to the following criteria:
A= Restoration is continuous with existing anatomic form. B= Restoration is discontinuous with existing anatomic form but missing material is not sufficient to expose dentin or lining.
C= Sufficient restorative material is lost to expose dentin.
*As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973.
As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Measured: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
Gingival Inflammation Index
Patient's gingiva will be assessed clinically according to Ryge (1973)* over time.
Assessments will be done to the following criteria:
0 = Normal gingiva.
- = Mild inflammation, slight change in color, slight edema, no bleeding upon probing.
- = Moderate inflammation, redness; edema and glazing; bleeding upon palpation.
- = Severe inflammation, marked redness and edema, ulceration, tendency to spontaneous bleeding.
- As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Note: At 6 months data was not reported. At Baseline, all patients presented a score of 0. Any patient with a score greater than zero would have been excluded at baseline.
Patients who received Class I restorations were not assessed as these restorations are limited to the chewing surface and not related to the health of gums.
Measured: 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startApr 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental CariesStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ricardo Walter, DDS, Principal investigator, University of PennsylvaniaAlan M. Atlas, DMD, Principal investigator, Academy House of Professional Offices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071953
- Sponsor's protocol ID
- 765-550
- Other IDs
- 815642
- Status last verified
- Nov 2022
- First submitted
- 21 Feb 2014
- Last updated
- 28 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of an Experimental Universal Adhesive Used With and Without Phosphoric Acid Pretreatment in Posterior Composite Resin Restorations
- ClinicalTrials.gov ID
- NCT02071953
- Acronym / sponsor ID
- 765-550
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Dentsply InternationalIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Posted 28 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intent of this study is to evaluate the clinical performance of an experimental dental bonding agent for use with dental restorative composites with and without pretreatment of the tooth dentin and enamel using phosphoric acid etching.
Detailed description
The intent of this study is to evaluate the clinical performance of an experimental dental bonding agent (adhesive) for use with dental restorative composites with and without pretreatment of the tooth dentin and enamel using phosphoric acid etching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adhesive without acid pretreatment | Experimental | Device: Experimental adhesive w/out phosphoric acid in post. rest.Experimental adhesive w/out phosphoric acid in post. rest. |
| Adhesive with acid pretreatment | Active comparator | Device: Experimental adhesive with phosphoric acid in post. rest.Experimental adhesive with phosphoric acid in post. rest. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in need of Class I and Class II restorations in premolars and molars.
Key exclusion criteria (6 listed)
- Patients with fewer than 20 teeth
- Patients exhibiting poor oral hygiene or uncontrolled periodontal disease
- Pregnant women or lactating mothers
- Patients with known allergies to HEMA or resin-based materials
- Patients with medical conditions that would contraindicate dental treatment
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 |
|---|---|---|
| Experimental adhesive w/out phosphoric acid in post. rest.Experimental adhesive without phosphoric acid in posterior restorations | Device | Adhesive without acid pretreatment |
| Experimental adhesive with phosphoric acid in post. rest.Experimental adhesive with phosphoric acid in posterior restorations | Device | Adhesive with acid pretreatment |
Primary outcome
Color Match
Time frame: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
The color match will be assessed clinically according to Ryge (1973)* for matching with adjacent teeth and stability of color matching over time. Assessments will be done to the following criteria: Alpha= Restoration matches adjacent tooth structure in shade and/or translucency. Bravo= Mismatch in shade and/or translucency is within normal range of tooth shades. Charlie= Mismatch in shade and/or translucency is outside normal range of tooth shades. *As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Marginal Discoloration
Time frame: Baseline, 6 months, 18 months. Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
Marginal discoloration will be assessed clinically according to Ryge (1973)* over time. Assessments will be done to the following criteria: Alpha= No visual evidence of marginal discoloration. Bravo= Marginal discoloration present but has not penetrated in a pulpal direction. Charlie= Marginal discoloration has penetrated in a pulpal direction. *As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Marginal Integrity
Time frame: Baseline, 6 months, 18 months. Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
Change in marginal integrity will be assessed clinically according to Ryge (1973)* over time. Assessments will be done to the following criteria: A= Explorer does not catch or slight catch with no visible crevice. B= Explorer catches and crevice is visible but no exposure of dentin or base. C= Explorer penetrates crevice and defect extended to amelo-dentinal junction. D= Restoration is fractured, mobile, or missing in part or in toto. *As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Presence of Secondary Dental Caries (Cavities)
Time frame: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
Change in presence of secondary dental caries will be assessed clinically according to Ryge (1973)* over time. Assessments will be done to the following criteria: A= No caries present. D= Caries present associated with the restoration. *As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed. Note: Secondary caries is a categorical, dichotomous variable, i.e. there is caries or not. This was assessed clinically and radiographically by a trained professional (dentist).
Presence of Restoration Fractures (Localized or Bulk)
Time frame: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
The restoration will be assessed clinically according to Ryge (1973)* for presence of fractures over time. Assessments will be done to the following criteria: A= Smooth restoration surface with no irregularities. B= Slightly rough or pitted restoration surface. Can be refinished. C= Deeply pitted or grooved (not related to anatomy) restoration finish. Can not be refinished. D= Restoration surface is fractured or flaking. *As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Post-operative Sensitivity
Time frame: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
Patient will be interviewed to assess post-operative sensitivity according to the following criteria: A= No sensitivity. B= Mild sensitivity. C= Moderate sensitivity with no restoration replacement required. D= Sever sensitivity. Replacement of restoration is required. Tooth sensitivity will be assessed at baseline and each follow-up appointment using cold thermal test (Endo-Ice, Hygienic) and Electric Pulp Test (EPT) when indicated.
Surface Condition of Restoration
Time frame: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
The change in surface condition of restoration will be assessed clinically according to Ryge (1973)* over time. Assessments will be done to the following criteria: A= Restoration is continuous with existing anatomic form. B= Restoration is discontinuous with existing anatomic form but missing material is not sufficient to expose dentin or lining. C= Sufficient restorative material is lost to expose dentin. *As per the Investigation Protocol, United States Public Health Service (USPHS) direct evaluation procedures were conducted using modified methods reported by Ryge in 1973. As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed.
Gingival Inflammation Index
Time frame: 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
Patient's gingiva will be assessed clinically according to Ryge (1973)* over time. Assessments will be done to the following criteria: 0 = Normal gingiva. 1. = Mild inflammation, slight change in color, slight edema, no bleeding upon probing. 2. = Moderate inflammation, redness; edema and glazing; bleeding upon palpation. 3. = Severe inflammation, marked redness and edema, ulceration, tendency to spontaneous bleeding. * As described by Ryge in 1973, the term "clinical assessment" means a visual examination by a dentist, using a mouth mirror, an explorer, and supplementary lighting as needed. Note: At 6 months data was not reported. At Baseline, all patients presented a score of 0. Any patient with a score greater than zero would have been excluded at baseline. Patients who received Class I restorations were not assessed as these restorations are limited to the chewing surface and not related to the health of gums.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ricardo Walter, DDS principal investigator
University of Pennsylvania
Alan M. Atlas, DMD principal investigator
Academy House of Professional Offices
Questions about this trial
What is this clinical trial studying?
A study testing Experimental adhesive w/out phosphoric acid in post. rest. and Experimental adhesive with phosphoric acid in post. rest. in people with Dental Caries, run by Dentsply International.
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 1 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 28 Nov 2022. 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?
Yes. Results are posted in the registry (first posted 28 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Color Match (time frame: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.). The study lists 8 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 28 Nov 2022.