3-year Evaluation of the Clinical Performances of a Self-adhesive Hybrid Resin Composite Compared to a Traditional Composite Resin Used for Direct Restorations of Non-carious Cervical Lesions (NCCLs): A Split-mouth Randomized Clinical Trial
Phase: NA
Conditions: Tooth Restoration
Sponsor: Dentsply Sirona Implants and Consumables

Protocol Synopsis: 14.1535 
09-Feb-2024 
1 (3) 
 
 
 
 
 
 
Title:  
 
3-year Evaluation of the Clinical Performances of a Self-adhesive Hybrid Resin 
Composite Compared to a Traditional Composite Resin Used for Direct 
Restorations of Non-carious Cervical Lesions (NCCLs): A Split-mouth 
Randomized Clinical Trial   
Identifier: NCT05751382 
Document date: 9-Feb-2024  
 
 
 

Protocol Synopsis: 14.1535 
09-Feb-2024 
2 (3) 
3-year Evaluation of the Clinical Performances of a Self-adhesive Hybrid Resin 
Composite Compared to a Traditional Composite Resin Used for Direct 
Restorations of Non-carious Cervical Lesions (NCCLs): A Split-mouth 
Randomized Clinical Trial    
Sponsor 
Dentsply DeTrey GmbH 
DeTrey Str. 1,  
78467 Konstanz  
Germany 
 
Principal Investigator  
Prof. Lorenzo Breschi 
Clinica Odontoiatrica (DIBINEM) 
Via San Vitale 59 
40125 Bologna 
Italy 
Anticipated number of study sites: 1 study site. 
Anticipated number of subjects: 50 (split-mouth design, i.e. Surefil one n=50, and Venous Pearl n=50). 
 
Background and overall aim  
Non carious cervical lesions (NCCL) are often restored due to dental sensitivity caused or for aesthetic 
reasons and in order to prevent further loss of mineralized tissue, with consequent pulp exposure. 
Numerous protocols of treatment have been proposed for V class cervical lesions. Treatment depends 
on the location and degree of dental materialized tissue loss, however, as soon as the lesion exposes 
the dentin, the restorative treatment may become necessary. Restorative therapy is often complicated 
by the absence of sufficient enamel tissue, dentin sclerosis and difficulty in isolation of the field. 
Furthermore, since the class V lesions tend to involve the anterior segments of the dental arches an 
incongruous restoration or pigmentations on the margins could affect the patients’ smile. Current 
research is directed towards the development of new materials and the improvement of the adhesion 
between the restorative materials and the mineralized dental surface trying to respect as much as 
possible the healthy dental tissues, and to obtain an impeccable aesthetics. In fact, we know that an 
unsatisfactory aesthetics is the main cause of rebuilding a restoration in the anterior section, unlike the 
posterior sectors where the main motivation for reintervention is bacterial infiltration that causes 
secondary caries.  
 
The aim of this study will be 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 comparison with traditional paste composite “Venus Pearl” employed in 
combination with iBond universal adhesive (Kulzer Dental) during an observational period of 3 years.  
 
Study objectives  
Primary objective 
The primary objective is assessment of restorative quality at 36 months follow-up using FDI and USPHS 
criteria. 
Secondary objectives 
The secondary objectives are to evaluate: 
▪ 
Restorative quality at 6-, 12- and 24-months follow-up using FDI and USPHS criteria.  
▪ 
Aesthetics at 6-, 12-, 24- and 36-months follow-up.  
▪ 
Level of pain at 6-, 12-, 24- and 36-months follow-up. 
▪ 
Time needed to perform the restoration. 
▪ 
Safety 

Protocol Synopsis: 14.1535 
09-Feb-2024 
3 (3) 
Study design  
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.  
Study population  
All patients will be treated at the Department of Conservative Dentistry of the University of Bologna, 
Italy. Patients showing NCCL will be screened to assess if they are eligible for participation according 
to below criteria. 
Inclusion criteria  
For inclusion in the study subject must meet all of the following criteria:  
1. Patients aging from 18 to 70 
2. 40-60% women, 40-60% men 
3. Patients who present at least 2 cervical lesions on canines and / or upper premolars on vital 
teeth 
4. Patients who are not allergic or sensitive to the ingredients contained in the products 
5. The test patient consents to the restorative treatment in line with the study´s criteria (informed 
consent) 
6. Sufficiently understanding of the language 
Exclusion criteria 
Any of the following is regarded as a criterion for exclusion from the study:  
1. Extremely low level of oral hygiene 
2. Teeth with previous restorations 
3. Not possible adequate isolation of the operating area 
4. Patients with serious systemic diseases 
5. Devitalized teeth or with pulpitis in progress 
6. Periodontal problems on the elements to be restored 
Materials employed in the study 
Adhesives: iBond Universal Adhesive (Kulzer, Germany).  
Composites: 
- 
Surefil one (Dentsply Sirona, Germany) 
- 
Venus Pearl (Kulzer, Germany) 
 
Indication 
Surefil one self-adhesive composite hybrid is a permanent bulk fill material for posterior restorations. 
 
Data Analyses: 
The differences between the two groups will be analyzed using a descriptive and inferential statistical 
analysis. The statistical analysis will be performed by the department of Biomedicinal and Neuro-Motor 
Sciences (DIBINEM) of the University of Bologna.  
 
Study timetable  
Anticipated study start: 
  
Sep 2022  
Anticipated completion:  
 
Sep 2026