Dental CariesNCT06558734
Pediatric Fiberglass Crown in Primary Teeth
A study testing Tooth Preperation and Cementation in people with Dental Caries and Dental Plaque, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled clinical trial aims to evaluate the clinical success of fiberglass crowns applied to primary teeth and to assess the impact of two different luting cements on the success of the fiberglass crowns. 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, Dental Plaque
- What is being tested?
- Tooth Preperation and Cementation
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 23 Nov 2022
- 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:
- absence of any systemic disease
- absence of any periodontal disease
- no unilateral chewing habit
- a Frankl scale score of three-four
- For teeth:
Show all 15Show fewer
- no percussion or palpation sensitivity
- no malocclusion
- no pathological mobility
- no pulpal treatment due to caries or other reasons
- had sound cervical margins
- not hypoplastic or hypocalcified
- had opposing functioning teeth
- had physiological root resorption not exceeding one-third of the root length
- had deep dentin caries with two or more surface that do not contain pulp involvement
Who cannot join
- did not attend their follow-up appointments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Clinical Success of Pediatric Fiberglass Crowns in Primary Teeth Using Different Luting Cements
This randomized controlled clinical trial aims to evaluate the clinical success of fiberglass crowns applied to primary teeth and to assess the impact of two different luting cements on the success of the fiberglass crowns. The main questions to answer are:
- Will fiberglass crowns demonstrate sufficient clinical success to serve as a viable alternative to existing pediatric crowns?
- Will there be any differences in the clinical success and mechanical properties of fiberglass crowns based on the type of luting cement used?
Read more
Thirty-eight children (60 teeth), between 5 and 9 years old (7.03±1.14), enrolled for the study. The researchers evaluated the clinical success of fiberglass crowns bonded with two different types of luting cement (1: FujiOne; 2: FujiCEM 2) based on retention, anatomical integrity, effect on periodontal health and parental satisfaction.
Participants will:
-Visit the clinic 1st, 3rd, 6th, 12th months after cementatiton.
- Conditions
- Dental Caries, Dental Plaque
- Being tested
- Tooth Preperation, Cementation
- Keywords
- Fiberglass crown, Glass-ionomer cement, Resin-modified glass-ionomer cement, Primary molar teeth
- Medical subject headings
- Dental Caries, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth PreperationProcedure or surgery
After the caries were removed, the teeth were prepared according to the manufacturer's recommendations for Figaro Crowns. Fiberglass crowns (Figaro Crowns Inc., USA) of the most suitable size in terms of the mesio-distal dimension of the tooth were selected. Following the establishment of anesthesia, the teeth were prepared using diamond cutting burs with a high-speed, water-cooled turbine handpiece. In order to achieve adequate interocclusal space, an occlusal reduction of 1-2 mm was executed along with a proximal reduction reaching 1 mm below the gingival margin. A more conservative reduction was applied to the buccal and lingual surfaces. After preparation, any remaining decayed dentin tissue was removed using a steel round bur with a low-speed micromotor. To ensure occlusal harmony, diamond burs were used to perform abrasion on the crown edges, and the trimmed crown edges were polished using rubber aids before cementation.
CementationProcedure or surgery
Figaro crowns were placed on the prepared teeth with finger pressure, following the manufacturer's instructions for the luting cement to be used. For each cement, the recommended setting time was observed, and excess cement residues were removed accordingly.
| Study group | Role | What they receive |
|---|---|---|
| Device: Glass-ionomer cement | Experimental | The capsule was attached to the mixer and mixed for 10 seconds. The cement was evenly distributed to the crowns paying attention that there were no air voids. Then crowns were placed by pressing them onto the prepared teeth with finger pressure. At least 2 minutes and 15 seconds after mixing, the excess cement was cleaned off. Following mixing, a minimum of 4 minutes and 30 seconds was allowed for the cement to set. Receives: Procedure: Tooth Preperation; Procedure: Cementation |
| Device: Resin-modified glass-ionomer cement | Experimental | FujiCEM 2 (GC, Tokyo, Japan) was evenly distributed to the inner surface of the crown with the syringe and immediately placed onto the teeth with finger pressure. The crowns were placed on the prepared tooth. At least 2 minutes and 15 seconds after mixing, the excess cement was cleaned off. Following mixing, a minimum of 4 minutes and 30 seconds was allowed for the cement to set. Receives: Procedure: Tooth Preperation; Procedure: Cementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crown success
Crown success was categorized as "successful" if no loss or fractures occurred and "unsuccessful" otherwise. Failed cases are classified as decementation, occlusal wear and fracture. Fracture classification includes large loss and chipped cases.
Measured: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Secondary outcomes (2)
Plaque Index
The Plaque Index scores of all teeth, including those treated with crowns (FGC group) and their symmetrical, healthy counterparts (control group), were evaluated and recorded, both before and after the application of the fiberglass crowns. The plaque Index was evaluated using the criteria established by Silness and Löe, with scores assigned as follows; 0 (the best): no plaque, 1: a film of plaque adhering to the free gingival margin and adjacent area of the tooth, 2: moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye and, 4 (the worst): abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. In the evaluation of the periodontal index, plaque control was carried out by utilizing a plaque-disclosing agent.
Measured: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Gingival Index
The Gingival Index scores of all teeth, including those treated with crowns (FGC group) and their symmetrical, healthy counterparts (control group), were evaluated and recorded, both before and after the application of the fiberglass crowns. The Gingival Index was evaluated using the criteria established by Silness and Löe, with scores assigned as follows; 0 (the best): normal gingiva, 1: mild inflammation, 2: moderate inflammation, and 4 (the worst): severe inflammation.
Measured: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start15 Jun 2020
- Primary completion20 Nov 2021
- Study completion23 Nov 2022
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 Akdeniz 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 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
- NCT06558734
- Sponsor's protocol ID
- TDH-2020-5280
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 19 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 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Success of Pediatric Fiberglass Crowns in Primary Teeth Using Different Luting Cements
- ClinicalTrials.gov ID
- NCT06558734
- Acronym / sponsor ID
- TDH-2020-5280
- Conditions
- Dental Caries, Dental Plaque
- Keywords
- Fiberglass crown, Glass-ionomer cement, Resin-modified glass-ionomer cement, Primary molar teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 19 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 clinical trial aims to evaluate the clinical success of fiberglass crowns applied to primary teeth and to assess the impact of two different luting cements on the success of the fiberglass crowns. The main questions to answer are:
- Will fiberglass crowns demonstrate sufficient clinical success to serve as a viable alternative to existing pediatric crowns?
- Will there be any differences in the clinical success and mechanical properties of fiberglass crowns based on the type of luting cement used?
Thirty-eight children (60 teeth), between 5 and 9 years old (7.03±1.14), enrolled for the study. The researchers evaluated the clinical success of fiberglass crowns bonded with two different types of luting cement (1: FujiOne; 2: FujiCEM 2) based on retention, anatomical integrity, effect on periodontal health and parental satisfaction.
Participants will:
-Visit the clinic 1st, 3rd, 6th, 12th months after cementatiton.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device: Glass-ionomer cement | Experimental | Procedure: Tooth Preperation, Procedure: CementationThe capsule was attached to the mixer and mixed for 10 seconds. The cement was evenly distributed to the crowns paying attention that there were no air voids. Then crowns were placed by pressing them onto the prepared teeth with finger pressure. At least 2 minutes and 15 seconds after mixing, the excess cement was cleaned off. Following mixing, a minimum of 4 minutes and 30 seconds was allowed for the cement to set. |
| Device: Resin-modified glass-ionomer cement | Experimental | Procedure: Tooth Preperation, Procedure: CementationFujiCEM 2 (GC, Tokyo, Japan) was evenly distributed to the inner surface of the crown with the syringe and immediately placed onto the teeth with finger pressure. The crowns were placed on the prepared tooth. At least 2 minutes and 15 seconds after mixing, the excess cement was cleaned off. Following mixing, a minimum of 4 minutes and 30 seconds was allowed for the cement to set. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- absence of any systemic disease
- absence of any periodontal disease
- no unilateral chewing habit
- a Frankl scale score of three-four
- no percussion or palpation sensitivity
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 |
|---|---|---|
| Tooth PreperationAfter the caries were removed, the teeth were prepared according to the manufacturer's recommendations for Figaro Crowns. Fiberglass crowns (Figaro Crowns Inc., USA) of the most suitable size in terms of the mesio-distal dimension of the tooth were selected. Following the establishment of anesthesia, the teeth were prepared using diamond cutting burs with a high-speed, water-cooled turbine handpiece. In order to achieve adequate interocclusal space, an occlusal reduction of 1-2 mm was executed along with a proximal reduction reaching 1 mm below the gingival margin. A more conservative reduction was applied to the buccal and lingual surfaces. After preparation, any remaining decayed dentin tissue was removed using a steel round bur with a low-speed micromotor. To ensure occlusal harmony, diamond burs were used to perform abrasion on the crown edges, and the trimmed crown edges were polished using rubber aids before cementation. | Procedure or surgery | Device: Glass-ionomer cement, Device: Resin-modified glass-ionomer cement |
| CementationFigaro crowns were placed on the prepared teeth with finger pressure, following the manufacturer's instructions for the luting cement to be used. For each cement, the recommended setting time was observed, and excess cement residues were removed accordingly. | Procedure or surgery | Device: Glass-ionomer cement, Device: Resin-modified glass-ionomer cement |
Primary outcome
Crown success
Time frame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Crown success was categorized as "successful" if no loss or fractures occurred and "unsuccessful" otherwise. Failed cases are classified as decementation, occlusal wear and fracture. Fracture classification includes large loss and chipped cases.
2 secondary outcomes
Plaque Index
Time frame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Gingival Index
Time frame: Evaluations were conducted at the 1st, 3rd, 6th, 12th 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 19 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 Tooth Preperation and Cementation in people with Dental Caries and Dental Plaque, 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 15 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 19 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?
Crown success (time frame: Evaluations were conducted at the 1st, 3rd, 6th, 12th 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 19 Aug 2024.