Dental CariesCENFPTNCT02093091
Clinical Evaluation of Nanoionomer Filling in Primary Teeth
A study testing Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano. and Dental caries was removed from primary molars and was filled with the conventional filling material;Vitremer in people with Dental Caries, run by Tanta University at 1 site in Egypt.
Trial summary
This clinical trial was performed to evaluate the nano-filled resin modified glass ionomer (RMGI) -with a brand name of "Ketac Nano"- as a filling material for the treatment of caries in primary teeth. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano. and Dental caries was removed from primary molars and was filled with the conventional filling material;Vitremer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2011to Oct 2013
- 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The presence of a bilateral identical pair of primary molars in the same arch containing initial occlusal caries (a minimum of two pits or fissures without any cusp destruction).
Who cannot join
- Handicapped or uncooperative children and children with extensive or rampant caries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two-year Clinical Performance in Primary Teeth of Nano-filled Versus Conventional Resin Modified Glass Ionomer Restorations
This clinical trial was performed to evaluate the nano-filled resin modified glass ionomer (RMGI) -with a brand name of "Ketac Nano"- as a filling material for the treatment of caries in primary teeth. Children aged 5-8 years were selected and treated with either Ketac Nano or another conventional RMGI called Vitremer. Then, the treated children were evaluated at baseline, after one yeat and after two years. The hypothesis to be tested in the present study was: The clinical performance of nano-filled RMGI (Ketac Nano) in class I primary molars will differ from that of its preceding conventional RMGI (Vitremer).
Read the detailed description
First, shear bond strength of each material to primary molars dentin specimens were measured (n=10) using a notched-edge crosshead. Independent sample t-test was used for statistical analysis. Then, a split mouth designed clinical trial was performed in which nano-filled RMGI; Ketac Nano (KN) and conventional RMGI; Vitremer (VR) were used to restore class I cavities of primary molars. Each material group (n=30) was evaluated according to the modified United States Public Health Service (USPHS) regarding marginal discoloration, marginal adaptation, color match, anatomic form and recurrent caries, at baseline, after one year and after two years. Wilcoxon signed- rank test and Chi-square test were used for statistical analysis.
- Conditions
- Dental Caries
- Being tested
- Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano., Dental caries was removed from primary molars and was filled with the conventional filling material;Vitremer
- Keywords
- nano-filled resin modified glass ionomer, clinical performance, class I, primary teeth, dentin bond strength, Filling of class I
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano.Procedure or surgery
Class I carious primary molars were selected. Dental caries was removed and cavities were prepared. The recent nano-filled RMGI filling (Ketac Nano) was used to fill these cavities.
Dental caries was removed from primary molars and was filled with the conventional filling material;VitremerProcedure or surgery
Class I carious primary molars were selected. Dental caries was removed and cavities were prepared. The conventional RMGI filling (Vitremer) was used to fill these cavities.
| Study group | Role | What they receive |
|---|---|---|
| Vitremer | Sham comparator | Dental caries was removed from primary molars and was filled with the conventional filling material;Vitremer (n = 30). The right molars was always filled by Vitremer. A split-mouth design was used in the present clinical trial. Twenty nine children were involved in the present study and every one had one bilateral identical pair of carious molars except one child that had two identical pairs. This design was performed to enhance the accuracy of the present study. Receives: Procedure: Dental caries was removed from primary molars and was filled with the conventional filling material;Vitremer |
| Ketac Nano | Active comparator | Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano (n=30). The left molars was always restored with Ketac Nano filling material. Receives: Procedure: Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of clinically definite deterioration of the evaluated filling materials at specific characters (parameters); marginal discoloration, marginal adaptation, color match, anatomic form and recurrent caries.
The filling materials were blindly evaluated by two trained investigators at specific characters or parameters according to the modified United States Public Health Service (USPHS). Each parameter has three grades of evaluation; Alfa (A), Bravo (B) and Charlie (C) that represent the degree of deterioration of the filling materials.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sahar E. Abo-Hamar, Tanta University
- Investigators
- Sahar E. Abo-Hamar, DMD, PhD, Principal investigator, Tanta University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093091
- Sponsor's protocol ID
- TantaU-Nano
- Acronym
- CENFPT
- Status last verified
- Mar 2014
- First submitted
- 11 Mar 2014
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-year Clinical Performance in Primary Teeth of Nano-filled Versus Conventional Resin Modified Glass Ionomer Restorations
- ClinicalTrials.gov ID
- NCT02093091
- Acronym / sponsor ID
- CENFPT / TantaU-Nano
- Conditions
- Dental Caries
- Keywords
- nano-filled resin modified glass ionomer, clinical performance, class I, primary teeth, dentin bond strength, Filling of class I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 20 Mar 2014 (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.
This clinical trial was performed to evaluate the nano-filled resin modified glass ionomer (RMGI) -with a brand name of "Ketac Nano"- as a filling material for the treatment of caries in primary teeth. Children aged 5-8 years were selected and treated with either Ketac Nano or another conventional RMGI called Vitremer. Then, the treated children were evaluated at baseline, after one yeat and after two years. The hypothesis to be tested in the present study was: The clinical performance of nano-filled RMGI (Ketac Nano) in class I primary molars will differ from that of its preceding conventional RMGI (Vitremer).
Detailed description
First, shear bond strength of each material to primary molars dentin specimens were measured (n=10) using a notched-edge crosshead. Independent sample t-test was used for statistical analysis. Then, a split mouth designed clinical trial was performed in which nano-filled RMGI; Ketac Nano (KN) and conventional RMGI; Vitremer (VR) were used to restore class I cavities of primary molars. Each material group (n=30) was evaluated according to the modified United States Public Health Service (USPHS) regarding marginal discoloration, marginal adaptation, color match, anatomic form and recurrent caries, at baseline, after one year and after two years. Wilcoxon signed- rank test and Chi-square test were used for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitremer | Sham comparator | Procedure: Dental caries was removed from primary molars and was filled with the conventional filling material;VitremerDental caries was removed from primary molars and was filled with the conventional filling material;Vitremer (n = 30). The right molars was always filled by Vitremer. A split-mouth design was used in the present clinical trial. Twenty nine children were involved in the present study and every one had one bilateral identical pair of carious molars except one child that had two identical pairs. This design was performed to enhance the accuracy of the present study. |
| Ketac Nano | Active comparator | Procedure: Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano.Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano (n=30). The left molars was always restored with Ketac Nano filling material. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The presence of a bilateral identical pair of primary molars in the same arch containing initial occlusal caries (a minimum of two pits or fissures without any cusp destruction).
Key exclusion criteria (1 listed)
- Handicapped or uncooperative children and children with extensive or rampant caries.
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 |
|---|---|---|
| Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano.Class I carious primary molars were selected. Dental caries was removed and cavities were prepared. The recent nano-filled RMGI filling (Ketac Nano) was used to fill these cavities. | Procedure or surgery | Ketac Nano |
| Dental caries was removed from primary molars and was filled with the conventional filling material;VitremerClass I carious primary molars were selected. Dental caries was removed and cavities were prepared. The conventional RMGI filling (Vitremer) was used to fill these cavities. | Procedure or surgery | Vitremer |
Primary outcome
Evidence of clinically definite deterioration of the evaluated filling materials at specific characters (parameters); marginal discoloration, marginal adaptation, color match, anatomic form and recurrent caries.
Time frame: 2 years
The filling materials were blindly evaluated by two trained investigators at specific characters or parameters according to the modified United States Public Health Service (USPHS). Each parameter has three grades of evaluation; Alfa (A), Bravo (B) and Charlie (C) that represent the degree of deterioration of the filling materials.
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 20 Mar 2014.
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
Sahar E. Abo-Hamar, DMD, PhD principal investigator
Tanta University, Faculty 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 Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano. and Dental caries was removed from primary molars and was filled with the conventional filling material;Vitremer in people with Dental Caries, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 1 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 20 Mar 2014. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Evidence of clinically definite deterioration of the evaluated filling materials at specific characters (parameters); marginal discoloration, marginal adaptation, color match, anatomic form and recurrent caries. (time frame: 2 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 20 Mar 2014.