Dental Restorations LongevityPhase 3NCT03834636
Impact of Patients Risk Factors on the Longevity of Aesthetic Restorations
A Phase 3 study testing Restorations with nanoparticulated composites and self etch adhesives, Restorations with nanoparticulated composites and total-etch adhesives and Restorations with nanohybrid composites and self etch adhesives in people with Dental Restorations Longevity and Dental Restoration Failure, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
The objective of this double-blind randomized clinical trial is to evaluate the influence of caries risk, occlusal stress and missing teeth on anterior restorations over a 10 years follow up period. Read more about this study
- Who is it for?
- Ages 9 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restorations Longevity, Dental Restoration Failure, Esthetics, Dental
- What is being tested?
- Restorations with nanoparticulated composites and self etch adhesives, Restorations with nanoparticulated composites and total-etch adhesives and Restorations with nanohybrid composites and self etch adhesives
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jan 2012to 10 Jan 2022
- Phase
- Phase 3
- 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 9 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with restorative needs in anterior teeth;
- Patients able to understand and sign the informed consent form;
- Patients willing to return to follow up.
Who cannot join
- Patients who had a need for Class III and Class IV restorations that did not involve at least 1/3 of the tooth;
- Patients under orthodontic treatment;
- Patients with a compromised general health condition, presenting a greater risk than ASA II, according to the ASA-PS (American Society of Anesthesiologists - Physical Status);
- Patients who had no occlusal contact with an opposing tooth and/or crown;
- Patient with absence of bilateral balanced occlusion;
- Patient with deep caries lesions in close contact with the dental pulp and in need of expectant treatment or direct pulp capping;
- Patients with post-retained need in anterior teeth.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal Univeristy of Pelotas
Pelotas, Rio Grande do Sul, 96015080
About this study
Official title: Impact of Patients Risk Factors, Type of Dental Material and Dental Technique on the Longevity of Aesthetic Dental Restorations
The objective of this double-blind randomized clinical trial is to evaluate the influence of caries risk, occlusal stress and missing teeth on anterior restorations over a 10 years follow up period. 300 teeth will be randomized according to two adhesive systems: Single Bond 2 and Single Bond Universal (3M ESPE); and two composite resins: nanoparticulated (Filtek ™ Z-350- 3M ESPE) and nanohybrid (IPS Empress Direct - Ivoclar Vivadent). The randomization will be stratified according to the risk of caries and cavity type. The primary outcomes will be longevity, annual failure rate (AFR) and the success of the restorations, and the secondary outcome will be causes for restorations' failure.
- Being tested
- Restorations with nanoparticulated composites and self etch adhesives, Restorations with nanoparticulated composites and total-etch adhesives, Restorations with nanohybrid composites and self etch adhesives, Restorations with nanohybrid composites and total-etch adhesives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restorations with nanoparticulated composites and self etch adhesivesProcedure or surgery
The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a self-etching dental adhesive (SingleBond Universal, 3M ESPE), selective enamel etching, and use of a nanoparticulated composite (Z350, 3M ESPE)
Restorations with nanoparticulated composites and total-etch adhesivesProcedure or surgery
The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a total-etching dental adhesive (SingleBond 2, 3M ESPE), and use of a nanoparticulated composite (Z350, 3M ESPE)
Restorations with nanohybrid composites and self etch adhesivesProcedure or surgery
The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a self-etching dental adhesive (SingleBond Universal, 3M ESPE), selective enamel etching, and use of a nanohybrid composite (IPS Empress Direct, Ivoclar Vivadent).
Restorations with nanohybrid composites and total-etch adhesivesProcedure or surgery
The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a total-etching dental adhesive (SingleBond 2, 3M ESPE), and use of a nanohybrid composite (IPS Empress Direct, Ivoclar Vivadent).
| Study group | Role | What they receive |
|---|---|---|
| Nanoparticulated composite - self-etch | Active comparator | Not described Receives: Procedure: Restorations with nanoparticulated composites and self etch adhesives |
| Nanoparticulated composite - total-etch | Active comparator | Not described Receives: Procedure: Restorations with nanoparticulated composites and total-etch adhesives |
| Nanohybrid composite - self-etch | Active comparator | Not described Receives: Procedure: Restorations with nanohybrid composites and self etch adhesives |
| Nanohybrid composite - total-etch | Active comparator | Not described Receives: Procedure: Restorations with nanohybrid composites and total-etch adhesives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of the restorations
Survival of the restoration is defined as any case where the restoration remains functional in the mouth at the time of evaluation, regardless of need of small interventions, such as repair or refurbishment. The restorations were evaluated shortly after baseline and in prospective periods through a direct clinical inspection, with an explorer probe and a clinical mirror, according to the criteria for clinical evaluation of restorations proposed by the FDI (International Dental Federation) (Hickel et al., 2010), the risks of caries and occlusal stress were also evaluated again.
Two trained and calibrated evaluators, unrelated to making the restorations, blinded to the type of material used, independently performed the clinical evaluations.
Measured: Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.
Success of the restorations
Success of the restoration is defined as any case where the restoration remains functional in the mouth at the time of evaluation, without any need of new interventions, and attending the patients demands. The restorations were evaluated shortly after baseline and in prospective periods through a direct clinical inspection, with an explorer probe and a clinical mirror, according to the criteria for clinical evaluation of restorations proposed by the FDI (International Dental Federation) (Hickel et al., 2010), the risks of caries and occlusal stress were also evaluated again.
Measured: Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.
Secondary outcomes (1)
Patient satisfaction with the treatment
Patient satisfaction will be recorded with FDI criteria
Measured: Changes in the patient's satisfaction status compared to baseline will be assessed yearly up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start10 Jan 2012
- Primary completion10 Jan 2022 (estimated)
- Study completion10 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Restorations LongevityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective randomized clinical trial, triple-blind, (patients, investigator and clinical evaluator) with parallel groups. After completing the ICDAS (International Caries Detection and Assessment), clinical occlusal stress examination and questionnaire application on occlusal stress, patients will be randomly divided into two types of dental adhesives and two types of composite resin. Randomization will be stratified according to the risk of caries determined by the ICDAS and the type of cavity to be filled. Operators (Master students and undergraduate students from the last year of the School of Dentistry, Federal University of Pelotas) will place the restorations supervised by highly trained clinicians.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximiliano Sergio Cenci, Federal University of Pelotas
- Investigators
- Maximiliano S Cenci, Principal investigator, Graduate Program in Dentistry - Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834636
- Sponsor's protocol ID
- PPGO 029
- Status last verified
- Feb 2019
- First submitted
- 7 Feb 2019
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Patients Risk Factors, Type of Dental Material and Dental Technique on the Longevity of Aesthetic Dental Restorations
- ClinicalTrials.gov ID
- NCT03834636
- Acronym / sponsor ID
- PPGO 029
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 10 Jan 2012 (actual)
- Primary completion
- 10 Jan 2022 (estimated)
- Study completion
- 10 Jan 2022 (estimated)
- First posted
- 8 Feb 2019 (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.
The objective of this double-blind randomized clinical trial is to evaluate the influence of caries risk, occlusal stress and missing teeth on anterior restorations over a 10 years follow up period. 300 teeth will be randomized according to two adhesive systems: Single Bond 2 and Single Bond Universal (3M ESPE); and two composite resins: nanoparticulated (Filtek ™ Z-350- 3M ESPE) and nanohybrid (IPS Empress Direct - Ivoclar Vivadent). The randomization will be stratified according to the risk of caries and cavity type. The primary outcomes will be longevity, annual failure rate (AFR) and the success of the restorations, and the secondary outcome will be causes for restorations' failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This study is a prospective randomized clinical trial, triple-blind, (patients, investigator and clinical evaluator) with parallel groups. After completing the ICDAS (International Caries Detection and Assessment), clinical occlusal stress examination and questionnaire application on occlusal stress, patients will be randomly divided into two types of dental adhesives and two types of composite resin. Randomization will be stratified according to the risk of caries determined by the ICDAS and the type of cavity to be filled. Operators (Master students and undergraduate students from the last year of the School of Dentistry, Federal University of Pelotas) will place the restorations supervised by highly trained clinicians.
| Arm | Type | Receives |
|---|---|---|
| Nanoparticulated composite - self-etch | Active comparator | Procedure: Restorations with nanoparticulated composites and self etch adhesives |
| Nanoparticulated composite - total-etch | Active comparator | Procedure: Restorations with nanoparticulated composites and total-etch adhesives |
| Nanohybrid composite - self-etch | Active comparator | Procedure: Restorations with nanohybrid composites and self etch adhesives |
| Nanohybrid composite - total-etch | Active comparator | Procedure: Restorations with nanohybrid composites and total-etch adhesives |
Who may qualify
- Ages
- 9 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with restorative needs in anterior teeth;
- Patients able to understand and sign the informed consent form;
- Patients willing to return to follow up.
Key exclusion criteria (7 listed)
- Patients who had a need for Class III and Class IV restorations that did not involve at least 1/3 of the tooth;
- Patients under orthodontic treatment;
- Patients with a compromised general health condition, presenting a greater risk than ASA II, according to the ASA-PS (American Society of Anesthesiologists - Physical Status);
- Patients who had no occlusal contact with an opposing tooth and/or crown;
- Patient with absence of bilateral balanced occlusion;
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 |
|---|---|---|
| Restorations with nanoparticulated composites and self etch adhesivesThe restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a self-etching dental adhesive (SingleBond Universal, 3M ESPE), selective enamel etching, and use of a nanoparticulated composite (Z350, 3M ESPE) | Procedure or surgery | Nanoparticulated composite - self-etch |
| Restorations with nanoparticulated composites and total-etch adhesivesThe restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a total-etching dental adhesive (SingleBond 2, 3M ESPE), and use of a nanoparticulated composite (Z350, 3M ESPE) | Procedure or surgery | Nanoparticulated composite - total-etch |
| Restorations with nanohybrid composites and self etch adhesivesThe restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a self-etching dental adhesive (SingleBond Universal, 3M ESPE), selective enamel etching, and use of a nanohybrid composite (IPS Empress Direct, Ivoclar Vivadent). | Procedure or surgery | Nanohybrid composite - self-etch |
| Restorations with nanohybrid composites and total-etch adhesivesThe restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a total-etching dental adhesive (SingleBond 2, 3M ESPE), and use of a nanohybrid composite (IPS Empress Direct, Ivoclar Vivadent). | Procedure or surgery | Nanohybrid composite - total-etch |
Primary outcome
Survival of the restorations
Time frame: Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.
Survival of the restoration is defined as any case where the restoration remains functional in the mouth at the time of evaluation, regardless of need of small interventions, such as repair or refurbishment. The restorations were evaluated shortly after baseline and in prospective periods through a direct clinical inspection, with an explorer probe and a clinical mirror, according to the criteria for clinical evaluation of restorations proposed by the FDI (International Dental Federation) (Hickel et al., 2010), the risks of caries and occlusal stress were also evaluated again. Two trained and calibrated evaluators, unrelated to making the restorations, blinded to the type of material used, independently performed the clinical evaluations.
Success of the restorations
Time frame: Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.
Success of the restoration is defined as any case where the restoration remains functional in the mouth at the time of evaluation, without any need of new interventions, and attending the patients demands. The restorations were evaluated shortly after baseline and in prospective periods through a direct clinical inspection, with an explorer probe and a clinical mirror, according to the criteria for clinical evaluation of restorations proposed by the FDI (International Dental Federation) (Hickel et al., 2010), the risks of caries and occlusal stress were also evaluated again.
1 secondary outcome
Patient satisfaction with the treatment
Time frame: Changes in the patient's satisfaction status compared to baseline will be assessed yearly up to 10 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- 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.
Maximiliano S Cenci principal investigator
Graduate Program in Dentistry - Federal University of Pelotas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Restorations with nanoparticulated composites and self etch adhesives, Restorations with nanoparticulated composites and total-etch adhesives and Restorations with nanohybrid composites and self etch adhesives in people with Dental Restorations Longevity and Dental Restoration Failure, run by Federal University of Pelotas at 1 site in Brazil.
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 3 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 8 Feb 2019. 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Survival of the restorations (time frame: Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.). The study lists 2 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 8 Feb 2019.