An interventional study of Basic Filling Material in Caries and Unsatisfactory Restoration of Tooth, sponsored by Istanbul Medipol University Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment
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.
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.
Istanbul Medipol University Hospital is the lead sponsor of 365 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Fillings made with a new dental filling material.
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.
Also known as: Dental Filling
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.
Time frame: at 3 years
Plaque accumulation according to the Silness & Löe (1964) Plaque Index
0 = No plaque in the gingival area. 1. = 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. 2. = 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. 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent
Time frame: at 3 years
Gingival Inflammation according to the Silness & Löe (1964) Gingival Index.
0 = Normal gingival. 1. = Mild inflammation-slight change in colour, slight oedema. No bleeding on probing 2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing. 3. = Severe inflammation-marked redness and oedema. Ulceration. Tendency to spontaneous bleeding
Time frame: at 3 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Istanbul Medipol University Hospital →