Unsatisfactory or Defective Restoration of Tooth Clinical Trial
Official title:
Evaluation of Clinical Performance and Periodontal Status of Posterior Indirect Resin Composite (Nexco) Restorations With Proximal Box Elevation Technique: A Prospective Controlled Clinical Trial up to 3 Years
Verified date | June 2023 |
Source | Istanbul Medipol University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Evaluation of posterior indirect resin composite restorations with proximal box elevation technique. Restoration of large posterior defects extending below the cemento-enamel junction (CEJ) with coverage of one or more cusps represent a very common clinical situation. When restoring deep cervical margins biological and technical operative problems may occur. In order to make clinical procedures less fault-prone 'Proximal Box Elevation' (PBE) is an option that refers to application of composite resin in the deepest parts of the proximal areas in order to reposition the cervical margin supragingivally prior to cavity preparation for an indirect restoration. This project aims to evaluate the clinical performance and periodontal status of posterior indirect composite restorations with PBE. According to study design at least 60 patients will be recruited to project and 80 restorations will be evaluated. The project will be carried out at the School of Dentistry, Istanbul Medipol University,Turkey.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | September 2025 |
Est. primary completion date | September 14, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Vital or endodontically treated posterior teeth with extensive substance loss 2. Caries removal or restoration replacement (i.e. amalgam, composite, glass-ionomer) 3. Large posterior defects with at least one or more cuspal coverage in molars 4. Proximal defects extending below CEJ and at least one or more cavity margin/margins located beneath the gingival tissues 5. Maximum 2 indirect restorations with SR Nexco material in each patient 6. No obvious untreated caries in the rest of the dentition, dental health problems (regularly checked by a dentist) 7. Good or moderate oral hygiene (plaque score of less than 30% in anterior region before treatment) 8. No untreated periodontal disease (only DPSI 1, 2) 9. Subjects had to be over 18 years of age, be classified according to the American Society of Anesthesiologists (ASA) as ASA I or ASA II, present with moderate to good oral hygiene, and be free of periodontal disease (probing depth and attachment levels within normal limits, no furcation involvement, and no mobility) 10. Appropriate isolation after cavity preparations 11. Subjects had to agree to keep the scheduled recall appointments for data collection and maintenance and plan to stay in the area for at least 3 years. Exclusion Criteria: 1. Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score 2 or 3 2. Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4) 2. Poor endodontic prognosis 3. Pulp exposure 4. Patients who still want to bleach their teeth or bleached teeth less than 3 weeks ago 5. Extremely hypersensitive tooth 6. Excluding the teeth, without opposing natural dentition (either intact or restored with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth 7. Substance loss due to developmental anomalies (hypoplasia, amelogenesis imperfecta etc.) 8. Subjects who presented severe wear facets and/or reported parafunctional activities such as clenching or nocturnal bruxism 9. Subjects who are pregnant or breast feeding during the duration of the study 10. Subjects who are known to be allergic to the ingredients of resin materials |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Medipol University, Dental School | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul Medipol University Hospital | Ivoclar Vivadent AG |
Turkey,
D'Arcangelo C, Zarow M, De Angelis F, Vadini M, Paolantonio M, Giannoni M, D'Amario M. Five-year retrospective clinical study of indirect composite restorations luted with a light-cured composite in posterior teeth. Clin Oral Investig. 2014;18(2):615-24. — View Citation
Dukic W, Dukic OL, Milardovic S, Delija B. Clinical evaluation of indirect composite restorations at baseline and 36 months after placement. Oper Dent. 2010 Mar-Apr;35(2):156-64. doi: 10.2341/09-133-C. — View Citation
Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent. 2010 Aug;12(4):259-72. doi: 10.3290/j.jad.a19262. — View Citation
Juloski J, Koken S, Ferrari M. Cervical margin relocation in indirect adhesive restorations: A literature review. J Prosthodont Res. 2018 Jul;62(3):273-280. doi: 10.1016/j.jpor.2017.09.005. Epub 2017 Nov 15. — View Citation
Veneziani M. Adhesive restorations in the posterior area with subgingival cervical margins: new classification and differentiated treatment approach. Eur J Esthet Dent. 2010 Spring;5(1):50-76. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FDI (World Dental Federation) criteria for dental restorations assessment | Two independent investigators are responsible for evaluations. The primary outcome will consist in the FDI (World Dental Federation) instruments for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010. This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually. The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome. | at 3 years | |
Secondary | Plaque accumulation according to the Silness & Löe (1964) Plaque Index: | The secondary outcome of the study relies on evaluation of periodontal status. Peridontal parameters will be scored between 0 and 3.
0= No plaque in the gingival area. A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface. Moderate accumulation of soft deposits within the gingival pocket, on the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye. Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface. |
at 3 years | |
Secondary | Gingival Inflammation according to the Silness & Löe (1964) Gingival Index. | 0= Normal gingival.
Mild inflammation-slight change in colour, slight oedema. No bleeding on probing. Moderate inflammation-redness, oedema and glazing. Bleeding on probing. Severe inflammation-marked redness and oedema. Ulceration. Tendency to spontaneous bleeding. |
at 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT01997710 -
Minimal Invasive Rehabilitation of Tooth Loss in the Posterior Segment (MIZE-S)
|
N/A | |
Withdrawn |
NCT01997827 -
Minimal Invasive Rehabilitation of Tooth Loss in the Anterior Segment
|
N/A | |
Recruiting |
NCT06457737 -
The Performance of Posterior Partial Coverage Coronal Restorations Luted With Two Differrent Systems.
|
N/A | |
Active, not recruiting |
NCT04796974 -
Clinical Evaluation of "Cention Forte" Restorative Material
|
N/A | |
Completed |
NCT01925040 -
Comparison of 2 Different Resin Based Filling Materials in Posterior Teeth - a Multicenter Study
|
N/A | |
Completed |
NCT03221660 -
Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy
|
N/A | |
Active, not recruiting |
NCT04686422 -
Clinical Evaluation of a Bulk Fill Resin Composite
|
N/A | |
Completed |
NCT02051179 -
Longitudinal Results of a 10-Year Clinical Trial of Repair of Amalgam Restorations
|
N/A |