Clinical Evaluation of Basic Filling Material in Class I and II Posterior Restorations

Caries Clinical Trial

Official title:

Clinical Evaluation of "Basic Filling" Material in Class I and II Cavities: A Prospective Controlled Clinical Trial up to 3 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763085
• Other study ID #: 283 (108400987-308)
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: November 2020

Study information

• Verified date: April 2023
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of a new basic filling restorative material.

In contemporary dentistry, clinicians have essentially three types of material choices for direct restorations: amalgam, resin composite, and glass ionomer restoratives.

Due to the toxicity of mercury and the subsequent environmental problems, the search for alternatives continues and search into new composite restorative materials intensifies. Recognized disadvantages of tooth colored resin based restorative materials are as polymerization shrinkage, postoperative sensitivity and technical procedure complexity. Higher rates of occlusal wear and lower toughness are disadvantages of glass ionomer restoratives.

Therefore, alternative materials are being developed to compensate the disadvantages of current contemporary tooth coloured restorative materials. Nevertheless, the search for simplification for restoring missing dental tissues introduced the "basic filling concept".

This project aims to study the clinical performance of this new basic filling restorative material for Class I and Class II cavities. 80 patients are recruited to the project which is carried out at the School of dentistry, Istanbul Medipol University, Turkey.

Description:

The objective of this study is to evaluate the clinical performance of a new basic filling restorative material for Class I and Class II cavities that needs to be restored in permanent teeth.

Basic filling material combines the handling properties of glass ionomer restorative materials with the mechanical properties of resin composite restorative materials.

Extensive laboratory studies have been performed on the new material, but the clinical attributes have yet to be disclosed.

The study will be carried out as a prospective study, with assessment of the restorations after three year.

The project includes 80 patients. Most of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul.

After giving their consent to take part in the study Class I & II restorations of both upper and lower molars and premolars are performed

The treatment procedure is:

The patients are offered local anesthetic before treatment start. The cavity is excavated and filled according to the guidelines for composite restorations.

The control procedure is:

The restoration is evaluated according to marginal adaptation, cavo surface marginal discoloration, approximal contact, fractures, caries associated with restorations and postoperative hypersensitivity. The controls will take place after two weeks, one year, two years and three years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2020
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Vital tooth

• Caries removal or restoration replacement (i.e. amalgam, composite, glass-ionomer)

• Class I & II restorations premolar and molars

• Maximum 2 fillings with the Basic Filling material in each patient

• No obvious untreated caries, dental health problems (regularly checked by a dentist)

• Good or moderate oral hygiene (plaque score of less than 30% in anterior region before treatment)

• No untreated periodontal disease (only DPSI 1, 2)

• Subjects had to be over the age of 18, 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)

Exclusion Criteria:

• Caries extends cemento-enamel junction in Class II

• Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score 2 or 3

• Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)

• Endodontic treatment

• Patients who still want to bleach their teeth or bleached teeth less than 3 weeks ago

• Excluding the teeth, without opposing natural dentition (either intact or restored with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth

• Subjects who presented with severe wear facets and/or reported parafunctional activities such as clenching or nocturnal bruxism

• Subjects who were pregnant or breast feeding during the duration of the study

• Subjects who are known to be allergic to the ingredients of resin materials

Related Conditions & MeSH terms

• Caries
• Unsatisfactory Restoration of Tooth

Intervention

Device:
• Basic Filling Material
Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the materials listed (Basic Filling Material). Procedures will be done using local anesthesia. The cavity is excavated and filled according to the guidelines for ordinary restorative techniques.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University School of Dentistry	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital	Ivoclar Vivadent AG

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FDI (World Dental Federation) criteria for dental restorations assessment	2 independent evaluators The primary outcome will consist in the FDI (World Dental Federation) instrument 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.; Hickel R, Peschke A, Tyas M, Mjör 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. Clin Oral Investig. 2010 Aug;14(4):349-66.	at 3 years
Secondary	Plaque accumulation according to the Silness & Löe (1964) Plaque Index	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	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