Tooth Restoration
Conditions
Brief summary
This is a split-mouth randomized clinical investigation conducted to evaluate clinical performances of a self-adhesive hybrid resin composite (investigational medical device Surefil) compared to a traditional composite resin, when used for direct restorations of non-carious lesions (NCCLs). The study consists of a 3-year long follow-up period.
Detailed description
The aim of this study is to demonstrate non-inferiority in terms of clinical performance and patient discomfort after direct restorative treatment of class V NCCL with Surefil one restorative material (Dentsply Sirona) in combination with a traditional paste composite Venus Pearl employed in combination with iBond universal adhesive (Kulzer Dental) during an observational period of 3 years.
Interventions
DEVICESurefil one
Restorative material (Dentsply Sirona). Used for direct restoration of class V NCCL.
DEVICEVenus Pearl
Restorative material. Traditional paste composite employed in combination with iBond universal adhesive.
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The aesthetic integration of the restoration will be evaluated by two experienced and blinded operators following the aesthetic criteria of the FDI.
Intervention model description
Split-mouth design, i.e. each subject have both treatment arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients aging from 18 to 70 * 40-60% women, 40-60% men * Patients who present at least 2 cervical lesions on canines and / or upper premolars on vital teeth * Patients who are not allergic or sensitive to the ingredients contained in the products * The test patient consents to the restorative treatment in line with the study´s criteria (informed consent) * Sufficiently understanding of the language
Exclusion criteria
* Extremely low level of oral hygiene * Teeth with previous restorations * Not possible adequate isolation of the operating area * Patients with serious systemic diseases * Devitalized teeth or with pulpitis in progress * Periodontal problems on the elements to be restored
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Restorative Quality | At 36 months follow-up. | The restorations will be evaluated using the World Dental Federation (FDI) criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Restorative Quality | At 6, 12 and 24 months follow-up | The restorations will be evaluated using the FDI criteria. |
| Assessment of Aesthetics | At 6, 12, 24 and 36 months follow-up | The aesthetic integration of the restoration will be evaluated by two experienced and blinded operators following the aesthetic criteria of the FDI. |
| Level of Pain | At 6, 12, 24 and 36 months follow-up | Sensitivity index: thermal yes/no, if yes then Visual Analogue Scale (VAS) index for level of pain. Air yes/no, if yes then VAS index for level of pain. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time Needed to Perform the Restoration | Day 0 | The time needed to perform the restorations will be compared between the groups. |
Countries
Italy
Participant flow
Recruitment details
Early termination.
Participants by arm
| Arm | Count |
|---|---|
| Restoration With Surefil One Hybrid Composite In a split-mouth design, subjects were randomly assigned to restoration with Surefil one hybrid composite in either the left or the right upper quadrant.
Restoration will be performed with Surefil one hybrid composite applied according to manufacturer's instruction and cured for 20 seconds with a LED lamp (Smartlamp Pro).
Surefil one: Restorative material (Dentsply Sirona). Used for direct restoration of class V NCCL. | 16 |
| Restoration With Surefil One Hybrid Composite In a split-mouth design, subjects were randomly assigned to restoration with Surefil one hybrid composite in either the left or the right upper quadrant.
Restoration will be performed with Surefil one hybrid composite applied according to manufacturer's instruction and cured for 20 seconds with a LED lamp (Smartlamp Pro).
Surefil one: Restorative material (Dentsply Sirona). Used for direct restoration of class V NCCL. | 16 |
| Restoration With Venus Pearl Composite In a split-mouth design, subjects were randomly assigned to restoration with Venus Pearl composite in either the left or the right upper quadrant.
After the application of the adhesive system (iBond universal), the Venus Pearl composite will be layered on the cavity and cured for 20 seconds with a LED lamp Smartlamp Pro).
Venus Pearl: Restorative material. Traditional paste composite employed in combination with iBond universal adhesive. | 16 |
| Restoration With Venus Pearl Composite In a split-mouth design, subjects were randomly assigned to restoration with Venus Pearl composite in either the left or the right upper quadrant.
After the application of the adhesive system (iBond universal), the Venus Pearl composite will be layered on the cavity and cured for 20 seconds with a LED lamp Smartlamp Pro).
Venus Pearl: Restorative material. Traditional paste composite employed in combination with iBond universal adhesive. | 16 |
| Total | 64 |
Baseline characteristics
| Characteristic | Restoration With Surefil One Hybrid Composite | Restoration With Venus Pearl Composite | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Assessment of Restorative Quality
The restorations will be evaluated using the World Dental Federation (FDI) criteria.
Time frame: At 36 months follow-up.
Population: Premature termination of study.
Primary
Assessment of Restorative Quality
The restorations will be evaluated using the United States Public Health Service (USPHS) criteria.
Time frame: At 36 months follow-up
Population: Premature termination of study.
Secondary
Assessment of Aesthetics
The aesthetic integration of the restoration will be evaluated by two experienced and blinded operators following the aesthetic criteria of the FDI.
Time frame: At 6, 12, 24 and 36 months follow-up
Secondary
Assessment of Restorative Quality
The restorations will be evaluated using the USPHS criteria.
Time frame: At 6, 12 and 24 months follow-up
Secondary
Assessment of Restorative Quality
The restorations will be evaluated using the FDI criteria.
Time frame: At 6, 12 and 24 months follow-up
Secondary
Level of Pain
Sensitivity index: thermal yes/no, if yes then Visual Analogue Scale (VAS) index for level of pain. Air yes/no, if yes then VAS index for level of pain.
Time frame: At 6, 12, 24 and 36 months follow-up
Other Pre-specified
Time Needed to Perform the Restoration
The time needed to perform the restorations will be compared between the groups.
Time frame: Day 0