CariesNCT02763085
Clinical Evaluation of Basic Filling Material in Class I and II Posterior Restorations
A study testing Basic Filling Material in people with Caries and Unsatisfactory Restoration of Tooth, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caries, Unsatisfactory Restoration of Tooth
- What is being tested?
- Basic Filling Material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2015to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University School of Dentistry
Istanbul, 34083
About this study
Official title: Clinical Evaluation of "Basic Filling" Material in Class I and II Cavities: A Prospective Controlled Clinical Trial up to 3 Years
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.
Read more
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.
Read the detailed 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.
- Conditions
- Caries, Unsatisfactory Restoration of Tooth
- Being tested
- Basic Filling Material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Filling MaterialDevice
Also called Dental Filling
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.
| Study group | Role | What they receive |
|---|---|---|
| Basic Filling Material | Experimental | Fillings made with a new dental filling material. Receives: Device: Basic Filling Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 3 years
Secondary outcomes (2)
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
Measured: at 3 years
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
Measured: at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJul 2015
- Primary completionSep 2018
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Responsible party
- Principal investigator, Funda Ozturk Bozkurt, Istanbul Medipol University Hospital
- Investigators
- Emir Yuzbasioglu, DDS,PhD, Principal investigator, Medipol UniversityMutlu Ozcan, DDS,PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763085
- Sponsor's protocol ID
- 283 (108400987-308)
- Status last verified
- Apr 2023
- First submitted
- 14 Feb 2016
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of "Basic Filling" Material in Class I and II Cavities: A Prospective Controlled Clinical Trial up to 3 Years
- ClinicalTrials.gov ID
- NCT02763085
- Acronym / sponsor ID
- 283 (108400987-308)
- Conditions
- Caries, Unsatisfactory Restoration of Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Study start
- Jul 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic Filling Material | Experimental | Device: Basic Filling MaterialFillings made with a new dental filling material. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Filling MaterialAlso: Dental FillingTooth (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. | Device | Basic Filling Material |
Primary outcome
FDI (World Dental Federation) criteria for dental restorations assessment
Time frame: at 3 years
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.
2 secondary outcomes
Plaque accumulation according to the Silness & Löe (1964) Plaque Index
Time frame: at 3 years
Gingival Inflammation according to the Silness & Löe (1964) Gingival Index.
Time frame: at 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emir Yuzbasioglu, DDS,PhD principal investigator
Medipol University
Mutlu Ozcan, DDS,PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Filling Material in people with Caries and Unsatisfactory Restoration of Tooth, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FDI (World Dental Federation) criteria for dental restorations assessment (time frame: at 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.