Dental CariesNCT06544486
Contemporary Restorative Materials in Primary Molars
A study testing Caries Removal and Filling in people with Dental Caries, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to compare the clinical effectiveness of four ion-releasing restorative materials in the proximal cavities of primary molars that underwent selective caries removal. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Caries Removal and Filling
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 19 Jul 2024
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For participants:
- no known or suspected history of allergy to medications or restorative materials
- no habits of teeth grinding or clenching
- presence of at least one interproximal carious lesion
- For teeth:
- carious lesion reaching at least 1/2 dentin
Show all 12Show fewer
- in contact with adjacent teeth and in occlusion with antagonist teeth
- have no pathological mobility
- periodontally healthy
- no symptoms of pulpal pathology
- physiological root resorption should not exceed one-third of the root length if seen
- permanent tooth germ present below the tooth
Who cannot join
- did not attend their follow-up appointments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Contemporary Ion Releasing Restorative Materials in Primary Molars Subjected to Selective Caries Removal: A Randomized Clinical Trial
This randomized controlled trial aims to compare the clinical effectiveness of four ion-releasing restorative materials in the proximal cavities of primary molars that underwent selective caries removal. The main questions to answer are:
- Will there be any difference among the restorative materials clinical succes in the means of modified United States Public Health Services (USPHS) criteria for dental restorations?
- Will there be any difference among the restorative materials in the means of preservation of pulpal vitality? Eighty six children (262 teeth), between 5 and 9 years old (7.15±1.14) enrolled for the study. Researchers will compare the clinical performance of restorative materials, (1:Equia Forte HT; 2: Fuji II LC; 3: Cention N; 4: ChemFil Rock), applied to the proximal cavities of primary molars following selective caries removal, according to the modified USPHS criteria.
Read more
Participants will:
- visit the clinic 1st,3rd,6th,12th,18th,24th,30th and 36th months after the restoration.
- Conditions
- Dental Caries
- Being tested
- Caries Removal, Filling
- Keywords
- Cention N, Resin-modified glass-ionomer cement, Hybrid glass-ionomer cement, Zinc reinforced glass-ionomer cement, Primary Molar Teeth
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caries RemovalProcedure or surgery
The cavity preparation and restoration were performed by a single operator. Infected dentin tissue was selectively removed. The differentiation between infected and affected dentin was determined by the clinician through the visual-tactile method.Isolation was achieved with cotton rolls and suction.
FillingProcedure or surgery
Sectional matrix systems and interdental wedges were used to achieve an anatomical contour and contact. Then, the selected materials were placed in the cavity according to the manufacturers' recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Device: Hybrid Glass-ionomer Cement (Equia Forte HT) | Experimental | The material in capsule form was placed in the mixer (Ultramat 2, SDI, Australia) and mixed for 10 seconds, and applied to the cavity in a single step. The restorative material was polymerized for 20 seconds using an LED light device (VALO, Ultradent, Utah, USA). Equia Forte Coat was applied and polymerized for 20 seconds. Receives: Procedure: Caries Removal; Procedure: Filling |
| Device: Resin-Modified Glass-ionomer Cement (Fuji II LC) | Experimental | The material in capsule form was mixed in the mixer (Ultramat 2, SDI, Australia) for 10 seconds, and applied to the cavity in a single step. Polymerization was achieved using an LED light device (VALO, Ultradent, Utah, USA) for 20 seconds. Receives: Procedure: Caries Removal; Procedure: Filling |
| Device: Bioactive Glass-Containing Alkasite (Cention N) | Experimental | The material was mixed using a plastic spatula on a mixing pad or glass with a powder-to-liquid ratio of 1:1 until it reached a homogeneous consistency, which took approximately 45 -60 seconds. Then the material was applied to the cavity and allowed to set for its self-curing time of 4 and a half minutes. Receives: Procedure: Caries Removal; Procedure: Filling |
| Device: Zinc-Reinforced High-Viscosity Glass-ionomer Cement (ChemFil Rock) | Experimental | The material in capsule form was placed in the mixer (Ultramat 2, SDI, Australia) and mixed for 12 seconds, and applied to the cavity in a single step. In addition to the 90-second working time, an additional 4 and a half minutes were allowed for the material to cure. Receives: Procedure: Caries Removal; Procedure: Filling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of the filling materials according to the modified USPHS criteria
Restorations were evaluated for retention, marginal discoloration, marginal adaptation, color stability, secondary caries, and postoperative sensitivity according to the modified USPHS with scores assigned as follows: the best being Alpha and the worst being Charlie. Each restoration received a score of Alpha, Bravo, or Charlie at each time interval.
Measured: Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.
Secondary outcomes (1)
Preservation of pulpal vitality
The modified USPHS criteria do not include the measure of pulpal vitality when evaluating the success of restorations. However, maintaining pulpal vitality is also a criterion for the success of a restoration and is assessed not by a graded score but by the presence or absence of symptoms and findings. In this study, pulpal vitality was clinically evaluated based on the presence or absence of percussion sensitivity, palpation sensitivity, gingival redness, fistula or abscess. If percussion sensitivity, palpation sensitivity, or the formation of a fistula or abscess were present, the restoration was classified as unsuccessful regarding pulpal vitality. In cases of gingival redness or unclear clinical symptoms, a periapical radiograph was taken. If presence or absence of radiolucency in the periapical or furcal area was detected in the radiograph, the restoration was classified as unsuccessful regarding pulpal vitality.
Measured: Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Mar 2021
- Primary completion21 Jun 2022
- Study completion19 Jul 2024
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zulfikar Zahit Ciftci, Akdeniz University
- Investigators
- Zulfikar Zahit Ciftci, Phd, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544486
- Sponsor's protocol ID
- TDH- 2022-5832
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Contemporary Ion Releasing Restorative Materials in Primary Molars Subjected to Selective Caries Removal: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06544486
- Acronym / sponsor ID
- TDH- 2022-5832
- Conditions
- Dental Caries
- Keywords
- Cention N, Resin-modified glass-ionomer cement, Hybrid glass-ionomer cement, Zinc reinforced glass-ionomer cement, Primary Molar Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 9 Aug 2024 (actual)
- 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 randomized controlled trial aims to compare the clinical effectiveness of four ion-releasing restorative materials in the proximal cavities of primary molars that underwent selective caries removal. The main questions to answer are:
- Will there be any difference among the restorative materials clinical succes in the means of modified United States Public Health Services (USPHS) criteria for dental restorations?
- Will there be any difference among the restorative materials in the means of preservation of pulpal vitality? Eighty six children (262 teeth), between 5 and 9 years old (7.15±1.14) enrolled for the study. Researchers will compare the clinical performance of restorative materials, (1:Equia Forte HT; 2: Fuji II LC; 3: Cention N; 4: ChemFil Rock), applied to the proximal cavities of primary molars following selective caries removal, according to the modified USPHS criteria.
Participants will:
- visit the clinic 1st,3rd,6th,12th,18th,24th,30th and 36th months after the restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Device: Hybrid Glass-ionomer Cement (Equia Forte HT) | Experimental | Procedure: Caries Removal, Procedure: FillingThe material in capsule form was placed in the mixer (Ultramat 2, SDI, Australia) and mixed for 10 seconds, and applied to the cavity in a single step. The restorative material was polymerized for 20 seconds using an LED light device (VALO, Ultradent, Utah, USA). Equia Forte Coat was applied and polymerized for 20 seconds. |
| Device: Resin-Modified Glass-ionomer Cement (Fuji II LC) | Experimental | Procedure: Caries Removal, Procedure: FillingThe material in capsule form was mixed in the mixer (Ultramat 2, SDI, Australia) for 10 seconds, and applied to the cavity in a single step. Polymerization was achieved using an LED light device (VALO, Ultradent, Utah, USA) for 20 seconds. |
| Device: Bioactive Glass-Containing Alkasite (Cention N) | Experimental | Procedure: Caries Removal, Procedure: FillingThe material was mixed using a plastic spatula on a mixing pad or glass with a powder-to-liquid ratio of 1:1 until it reached a homogeneous consistency, which took approximately 45 -60 seconds. Then the material was applied to the cavity and allowed to set for its self-curing time of 4 and a half minutes. |
| Device: Zinc-Reinforced High-Viscosity Glass-ionomer Cement (ChemFil Rock) | Experimental | Procedure: Caries Removal, Procedure: FillingThe material in capsule form was placed in the mixer (Ultramat 2, SDI, Australia) and mixed for 12 seconds, and applied to the cavity in a single step. In addition to the 90-second working time, an additional 4 and a half minutes were allowed for the material to cure. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- no known or suspected history of allergy to medications or restorative materials
- no habits of teeth grinding or clenching
- presence of at least one interproximal carious lesion
- carious lesion reaching at least 1/2 dentin
- in contact with adjacent teeth and in occlusion with antagonist teeth
Key exclusion criteria (1 listed)
- did not attend their follow-up appointments
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 |
|---|---|---|
| Caries RemovalThe cavity preparation and restoration were performed by a single operator. Infected dentin tissue was selectively removed. The differentiation between infected and affected dentin was determined by the clinician through the visual-tactile method.Isolation was achieved with cotton rolls and suction. | Procedure or surgery | Device: Bioactive Glass-Containing Alkasite (Cention N), Device: Hybrid Glass-ionomer Cement (Equia Forte HT), Device: Resin-Modified Glass-ionomer Cement (Fuji II LC), Device: Zinc-Reinforced High-Viscosity Glass-ionomer Cement (ChemFil Rock) |
| FillingSectional matrix systems and interdental wedges were used to achieve an anatomical contour and contact. Then, the selected materials were placed in the cavity according to the manufacturers' recommendations. | Procedure or surgery | Device: Bioactive Glass-Containing Alkasite (Cention N), Device: Hybrid Glass-ionomer Cement (Equia Forte HT), Device: Resin-Modified Glass-ionomer Cement (Fuji II LC), Device: Zinc-Reinforced High-Viscosity Glass-ionomer Cement (ChemFil Rock) |
Primary outcome
Clinical evaluation of the filling materials according to the modified USPHS criteria
Time frame: Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.
Restorations were evaluated for retention, marginal discoloration, marginal adaptation, color stability, secondary caries, and postoperative sensitivity according to the modified USPHS with scores assigned as follows: the best being Alpha and the worst being Charlie. Each restoration received a score of Alpha, Bravo, or Charlie at each time interval.
1 secondary outcome
Preservation of pulpal vitality
Time frame: Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.
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 9 Aug 2024.
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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.
Zulfikar Zahit Ciftci, Phd principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caries Removal and Filling in people with Dental Caries, run by Akdeniz 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 12 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 9 Aug 2024. 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?
Clinical evaluation of the filling materials according to the modified USPHS criteria (time frame: Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.). 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 9 Aug 2024.