Dental CariesNCT02888873
Comparison of Two Universal Composites in Posterior Teeth
A study testing Charisma and Charisma Classic in people with Dental Caries, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized, prospective clinical study was to compare the clinical performance of a universal light-curing, ultra-fine particle hybrid composite with a new version of this product produced by the same manufacturer in Class 1 and Class 2 lesions. Read more about this study
- Who is it for?
- Ages 18 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Charisma and Charisma Classic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2014to May 2016
- 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 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- a need for at least two but not more than four posterior tooth-colored restorations
- the presence of teeth to be restored in occlusion
- teeth that were symptomless and vital
- a normal periodontal status
- a good likelihood of recall availability.
Who cannot join
- partly erupted teeth
- absence of adjacent and antagonist teeth
- poor periodontal status
- adverse medical history
- potential behavioral problems.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University School of Dentistry
Ankara, 06100
About this study
Official title: Prospective, Randomized, Controlled, Double Blind Trial of Two Universal Composites in Posterior Teeth
The aim of this randomized, prospective clinical study was to compare the clinical performance of a universal light-curing, ultra-fine particle hybrid composite with a new version of this product produced by the same manufacturer in Class 1 and Class 2 lesions.
Read the detailed description
A total of 80 (13 Class 1 and 67 Class 2) lesions in 40 patients (21 females, 19 males) with ages ranging between 18-38 years (23.15±5.15) were either restored with Charisma or Charisma Classic (Heraeus Kulzer) in combination with an etch and rinse adhesive system (Gluma 2 Bond) under rubber dam isolation by two experienced operators according to the manufacturer's instructions. Two independent examiners, who were blinded to the composites used evaluated the restorations according to the FDI (World Dental Federation) criteria. Bite-wing radiographs and intraoral digital photographs were taken before and after treatment and at 6 months. The statistical analyses were carried out with McNemar, Pearson Chi-square and Cochran Q tests (p<0.05).
- Conditions
- Dental Caries
- Being tested
- Charisma, Charisma Classic
- Keywords
- composite resin, Clinical trial, FDI (World Dental Federation) criteria
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CharismaOther
Also called universal composite
The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Charisma was used in combination Gluma2 Bond etch\&rinse adhesive. The composite resin restorations were light-cured (600 milliwatt/cm²). Occlusion was checked with thin articulating papers.
Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups.
Charisma ClassicOther
Also called universal composite
The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Charisma classic was used in combination Gluma2 Bond etch\&rinse adhesive. The composite resin restorations were light-cured (600 milliwatt/cm²). Occlusion was checked with thin articulating papers.
Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups.
| Study group | Role | What they receive |
|---|---|---|
| Charisma | Active comparator | applied randomly Receives: Other: Charisma |
| Charisma classic | Active comparator | applied randomly Receives: Other: Charisma Classic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observers evaluated the esthetic properties of the restorations using FDI (World Dental Federation) Criteria.
"Surface luster"; "Staining (surface, margins)"; "Color match and translucency"; "Esthetic anatomical form"
Measured: The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
Secondary outcomes (1)
Observers evaluated the functional properties of the restorations using FDI (World Dental Federation) Criteria.
"Fracture of material and retention"; "Marginal adaptation"
Measured: The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Bilge Kutuk, Hacettepe University
- Investigators
- Sevil Gurgan, DDS, PhD, Study director, Hacettepe University School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888873
- Sponsor's protocol ID
- 2014/03-13(KA-14005)
- Status last verified
- Aug 2016
- First submitted
- 24 Aug 2016
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Gurgan S, Vural UK, Kutuk ZB, Cakir FY. Comparison of two universal composites in posterior teeth: preliminary report. J Dent Res (Spec Iss 94 B): 308, 2015
Gurgan S, Koc Vural U, Kutuk ZB, Cakir FY. Does a new formula have an input in the clinical success of posterior composite restorations? A chat study. Clin Oral Investig. 2021 Apr;25(4):1715-1727. doi: 10.1007/s00784-020-03472-5. Epub 2020 Aug 3.
PubMed 32748072
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled, Double Blind Trial of Two Universal Composites in Posterior Teeth
- ClinicalTrials.gov ID
- NCT02888873
- Acronym / sponsor ID
- 2014/03-13(KA-14005)
- Conditions
- Dental Caries
- Keywords
- composite resin, Clinical trial, FDI (World Dental Federation) criteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 5 Sep 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.
The aim of this randomized, prospective clinical study was to compare the clinical performance of a universal light-curing, ultra-fine particle hybrid composite with a new version of this product produced by the same manufacturer in Class 1 and Class 2 lesions.
Detailed description
A total of 80 (13 Class 1 and 67 Class 2) lesions in 40 patients (21 females, 19 males) with ages ranging between 18-38 years (23.15±5.15) were either restored with Charisma or Charisma Classic (Heraeus Kulzer) in combination with an etch and rinse adhesive system (Gluma 2 Bond) under rubber dam isolation by two experienced operators according to the manufacturer's instructions. Two independent examiners, who were blinded to the composites used evaluated the restorations according to the FDI (World Dental Federation) criteria. Bite-wing radiographs and intraoral digital photographs were taken before and after treatment and at 6 months. The statistical analyses were carried out with McNemar, Pearson Chi-square and Cochran Q tests (p<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Charisma | Active comparator | Other: Charismaapplied randomly |
| Charisma classic | Active comparator | Other: Charisma Classicapplied randomly |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- a need for at least two but not more than four posterior tooth-colored restorations
- the presence of teeth to be restored in occlusion
- teeth that were symptomless and vital
- a normal periodontal status
- a good likelihood of recall availability.
Key exclusion criteria (5 listed)
- partly erupted teeth
- absence of adjacent and antagonist teeth
- poor periodontal status
- adverse medical history
- potential behavioral problems.
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 |
|---|---|---|
| CharismaAlso: universal compositeThe surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Charisma was used in combination Gluma2 Bond etch\&rinse adhesive. The composite resin restorations were light-cured (600 milliwatt/cm²). Occlusion was checked with thin articulating papers. Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups. | Other | Charisma |
| Charisma ClassicAlso: universal compositeThe surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Charisma classic was used in combination Gluma2 Bond etch\&rinse adhesive. The composite resin restorations were light-cured (600 milliwatt/cm²). Occlusion was checked with thin articulating papers. Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups. | Other | Charisma classic |
Primary outcome
Observers evaluated the esthetic properties of the restorations using FDI (World Dental Federation) Criteria.
Time frame: The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
"Surface luster"; "Staining (surface, margins)"; "Color match and translucency"; "Esthetic anatomical form"
1 secondary outcome
Observers evaluated the functional properties of the restorations using FDI (World Dental Federation) Criteria.
Time frame: The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
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 5 Sep 2016.
- Results publicationGurgan S, Vural UK, Kutuk ZB, Cakir FY. Comparison of two universal composites in posterior teeth: preliminary report. J Dent Res (Spec Iss 94 B): 308, 2015
- Derived from this study: PubMed 32748072Gurgan S, Koc Vural U, Kutuk ZB, Cakir FY. Does a new formula have an input in the clinical success of posterior composite restorations? A chat study. Clin Oral Investig. 2021 Apr;25(4):1715-1727. doi: 10.1007/s00784-020-03472-5. Epub 2020 Aug 3.
- Individual participant dataSharing planned: Yes
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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.
Sevil Gurgan, DDS, PhD study director
Hacettepe University School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Charisma and Charisma Classic in people with Dental Caries, run by Hacettepe University 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 5 inclusion and 5 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 5 Sep 2016. 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?
Observers evaluated the esthetic properties of the restorations using FDI (World Dental Federation) Criteria. (time frame: The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02888873, which also lists 2 linked publications.
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 5 Sep 2016.