Prosthodontics E06.780FRCPDsNCT02764463
15 Years Control of Fiber Reenforced Composite Fixed Partial Dentures
A study testing Fiber Reinforced Composite Fixed Partial Dentures in people with Prosthodontics E06.780, run by BNM Clinic and Research.
Trial summary
This prospective clinical study evaluated the performance of indirect, posterior occlusal-retained, fiber-reinforced-composite restorations. Methods: Between June 1999 and June 2000, a total of 58 patients aged between 33 and 62 years old ( 33 male, 25 female) received 65 FCRFPD prosthesis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prosthodontics E06.780
- What is being tested?
- Fiber Reinforced Composite Fixed Partial Dentures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Jun 1999to Jan 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
- All subjects were required to be at least 18 years old, able to read and sign the informed consent document
- Physically and psychologically able to tolerate conventional restorative procedures
- Having no active periodontal or pulpal diseases
- Having no primary caries
- Not allergic to resin-based materials
- Not pregnant or nursing
- Having antagonist teeth opposing the FRC FDP to be restored
- Willing to return for follow-up examinations as outlined by the investigators.
Who cannot join
- Patients who had more absent teeth than the tooth to be replaced in the rest of the dentition or those having diastemas were not excluded.
About this study
Official title: Clinical Survival of Indirect, Lateral-posterior 3-unit Occlusal-retained Fiber-reinforced Composite Fixed Dental Prosthesis: 15-years Follow-up
This prospective clinical study evaluated the performance of indirect, posterior occlusal-retained, fiber-reinforced-composite restorations.
Methods: Between June 1999 and June 2000, a total of 58 patients aged between 33 and 62 years old ( 33 male, 25 female) received 65 FCRFPD prosthesis.
All restorations were made indirectly on a plaster model using unidirectional E-glass fibers (Vectris- Ivoclar Vivadent, liechtenstein) in combination with a laboratory resin composite (Signum, Heraeus-Kulzer) and cemented according to the instructions of resin cement Variolink II (Ivoclar Vivadent). After baseline recordings, patients were followed at 6 months and thereafter annually up to 15 years. The evaluation protocol involved technical (chipping, debonding or fracture of tooth/restoration) and biological failures (caries).
Read the detailed description
As of January 1999, FRC FDPs are offered as alternative to other conventional therapy options at the Department where the study was conducted. Between June-1999 and June-2000, 58 patients aged between 33 and 62 years old (25 females, 33 males, mean age: 47) received 65 indirect posterior FRC FDPs. Before enrolment in the trial, all patients were provided with a written informed consent Information was given to each patient regarding the alternative treatment options. The inclusion criteria were as follows: all subjects were required to be at least 18 years old, able to read and sign the informed consent document, physically and psychologically able to tolerate conventional restorative procedures, having no active periodontal or pulpal diseases, having no primary caries, not allergic to resin-based materials, not pregnant or nursing, having antagonist teeth opposing the FRC FDP to be restored, willing to return for follow-up examinations as outlined by the investigators. The patients who had more absent teeth than the tooth to be replaced in the rest of the dentition or those having diastemas were not excluded.
All the restorations were performed by a single operator, selected considering his clinical experience (>10 years since graduation).
All FDPs replaced one missing tooth and bonded to two adjacent abutment teeth were used for retention. No cantilever FDPs were involved.
Treatment was performed in two sessions: 1) Teeth preparation and Impression taking and model analysis, 2) Try-in, cementation and polishing of the FDP.
In the first session, after an accurate evaluation of spaces and residual dental tissues and the acceptance of this type of treatment by the patient, pillar teeth were prepared using diamond bur on high speed handpiece with mesio-occlusal, disto-occlusal, MOD, onlay or overlay preparations according to each clinical situation. Cavity preparation is required not only to remove all carious tissue, but to create a minimal space necessary to the glass fibers to support occlusal loads. According to "Munack" a cavity with 2x2mm occlusal surface and 2mm depth is able to support a 600N masticatory stress before breaking, and by increasing depth to 4mm we can reach 700N.
All cavity designs are realized following these criteria:
minimum preparation depth of 2.5mm minimum cavity width of 2mm divergent proximal boxes bucco-lingual width of proximal boxes at least 3.5m round internal angles. Cavity preparations were done under rubber dam with a diamond bur (100micron) with high-speed handpiece, in case of carious tissue this was removed finely. After finishing, all cavities were cleaned with air-water spray and gently air-dried in order to apply 37% phosphoric acid etchant gel on enamel and dentin. The cavities were then rinsed for 30 s with air-water spray and dried using suction to keep some moisture in dentin and a layer of bonding is applied onto the surface and light-cured. Composite material was applied in the cavities in order to create a block-out, that will eliminate undercuts and increase thickness of residual walls.
Preparations were then finished and polished with fine grain burs(60 and 40 micron respectively). After removing rubber dam, complete arch impressions were taken with a polyether material followed by disinfecting the impressions for 10 min . Provisional restorations were placed with eugenol-free temporary cement . Dental impressions and photographs are sent to dental technician for FRCFPD fabrication.
FRC FDPs were made in one dental laboratory on the full arch plaster cast. The model was first isolated with two coats of isolation medium. One unidirectional pre-impregnated E-glass fibers (Vectris- Ivoclar Vivadent, Lienchestein) was used to reinforce the veneering composite. Each bundle consists of about 4000 glass fibers, with a diameter of 1.7 mm, embedded in a PMMA/bis-GMA matrix. Before the fibers were placed on the cast, a layer of composite was applied into the interproximal-occlusal box of the abutment teeth. The fiber bundle was placed in the bed of the flowable resin using metal hand instruments.
After photo-polymerization with a halogen polymerization unit (light output: 1200 mw/cm2), the framework was veneered with a resin composite An opaque resin was used in some cases to improve the optical properties. The veneering resin composite was built incrementally; the construction was polymerized for the final time with a heat-light polymerization oven.
In the second session, after rubber dam placement and removal of provisional restorations, the teeth were cleaned with a prophylaxis brush and pumice. After try-in of the FRCFPD to check proximal contacts and marginal fit, all adhesive surfaces of the restoration were sandblasted, and then cleaned with ethanol and air-dried.
The cementation surface of the FDP was treated with resin monomer of the corresponding resin cement using a micro brush (Heliobond Ivoclar Vivadent, liechtenstein). The resin was left unpolymerized, shielded from light, for at least 5 minutes to allow the resin to penetrate and activate the IPN-phase of the polymethacrylate polymer matrix of the FRC framework.
The tooth surface was prepared for adhesion by applying a three step etch and rinse adhesive. After removal of excess resin, all restorations were cemented using a resin cement Variolink II . light-cured for 40s on each surface (lingual, labial, mesial, distal) (Astralis 10, SN 018766, Ivoclar Vivadent, light output: 1200 mW/cm2). Static and dynamic occlusion was adjusted using fine grit diamond burs. The power output of the unit was measured with a radiometer ( before the placement of each restoration. After polymerization, restoration margins were finished. Occlusion was adjusted with fine diamond burs (60- and 40-µm grit) and finally, the restoration was polished with pointed silicon polishers and abrasive polishing brushes. Patients received individual instructions to maintain plaque control.
One operator applied all the restorations who has experience in adhesive dentistry (>10 years since graduation).
- Conditions
- Prosthodontics E06.780
- Being tested
- Fiber Reinforced Composite Fixed Partial Dentures
- Keywords
- Fiber Reinforced Composites, Resin cements, Survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber Reinforced Composite Fixed Partial DenturesDevice
Also called FRCPDs
All restorations were made indirectly on a plaster model using unidirectional E-glass fibers (Vectris- Ivoclar Vivadent, , liechtenstein) in combination with a laboratory resin composite (Signum, Heraeus-Kulzer)
| Study group | Role | What they receive |
|---|---|---|
| FRCFPDs | Other | Fiber reenforced Composite Fixed Partial Dentures Receives: Device: Fiber Reinforced Composite Fixed Partial Dentures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Debonding of restoration
According to USPHS criteria
Measured: 15 Years
Fracture of Tooth
According to USPHS criteria
Measured: 15 Years
Fracture of Restorations
According to USPHS criteria
Measured: 15 Years
Chipping of restoration
According to USPHS criteria
Measured: 15 Years
Secondary outcomes (1)
Secondary caries of the tooth
According to USPHS criteria
Measured: 15 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startJun 1999
- Primary completionSep 2016 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthodontics E06.780Studies 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- BNM Clinic and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Barabanti, BNM Clinic and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764463
- Sponsor's protocol ID
- FRCPDS15Y
- Acronym
- FRCPDs
- Status last verified
- Jul 2016
- First submitted
- 15 Mar 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Survival of Indirect, Lateral-posterior 3-unit Occlusal-retained Fiber-reinforced Composite Fixed Dental Prosthesis: 15-years Follow-up
- ClinicalTrials.gov ID
- NCT02764463
- Acronym / sponsor ID
- FRCPDs / FRCPDS15Y
- Conditions
- Prosthodontics E06.780
- Keywords
- Fiber Reinforced Composites, Resin cements, Survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (actual)
- Lead sponsor
- BNM Clinic and ResearchUniversity, hospital or other
- Study start
- Jun 1999
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 6 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.
This prospective clinical study evaluated the performance of indirect, posterior occlusal-retained, fiber-reinforced-composite restorations.
Methods: Between June 1999 and June 2000, a total of 58 patients aged between 33 and 62 years old ( 33 male, 25 female) received 65 FCRFPD prosthesis.
All restorations were made indirectly on a plaster model using unidirectional E-glass fibers (Vectris- Ivoclar Vivadent, liechtenstein) in combination with a laboratory resin composite (Signum, Heraeus-Kulzer) and cemented according to the instructions of resin cement Variolink II (Ivoclar Vivadent). After baseline recordings, patients were followed at 6 months and thereafter annually up to 15 years. The evaluation protocol involved technical (chipping, debonding or fracture of tooth/restoration) and biological failures (caries).
Detailed description
As of January 1999, FRC FDPs are offered as alternative to other conventional therapy options at the Department where the study was conducted. Between June-1999 and June-2000, 58 patients aged between 33 and 62 years old (25 females, 33 males, mean age: 47) received 65 indirect posterior FRC FDPs. Before enrolment in the trial, all patients were provided with a written informed consent Information was given to each patient regarding the alternative treatment options. The inclusion criteria were as follows: all subjects were required to be at least 18 years old, able to read and sign the informed consent document, physically and psychologically able to tolerate conventional restorative procedures, having no active periodontal or pulpal diseases, having no primary caries, not allergic to resin-based materials, not pregnant or nursing, having antagonist teeth opposing the FRC FDP to be restored, willing to return for follow-up examinations as outlined by the investigators. The patients who had more absent teeth than the tooth to be replaced in the rest of the dentition or those having diastemas were not excluded.
All the restorations were performed by a single operator, selected considering his clinical experience (>10 years since graduation).
All FDPs replaced one missing tooth and bonded to two adjacent abutment teeth were used for retention. No cantilever FDPs were involved.
Treatment was performed in two sessions: 1) Teeth preparation and Impression taking and model analysis, 2) Try-in, cementation and polishing of the FDP.
In the first session, after an accurate evaluation of spaces and residual dental tissues and the acceptance of this type of treatment by the patient, pillar teeth were prepared using diamond bur on high speed handpiece with mesio-occlusal, disto-occlusal, MOD, onlay or overlay preparations according to each clinical situation. Cavity preparation is required not only to remove all carious tissue, but to create a minimal space necessary to the glass fibers to support occlusal loads. According to "Munack" a cavity with 2x2mm occlusal surface and 2mm depth is able to support a 600N masticatory stress before breaking, and by increasing depth to 4mm we can reach 700N.
All cavity designs are realized following these criteria:
minimum preparation depth of 2.5mm minimum cavity width of 2mm divergent proximal boxes bucco-lingual width of proximal boxes at least 3.5m round internal angles. Cavity preparations were done under rubber dam with a diamond bur (100micron) with high-speed handpiece, in case of carious tissue this was removed finely. After finishing, all cavities were cleaned with air-water spray and gently air-dried in order to apply 37% phosphoric acid etchant gel on enamel and dentin. The cavities were then rinsed for 30 s with air-water spray and dried using suction to keep some moisture in dentin and a layer of bonding is applied onto the surface and light-cured. Composite material was applied in the cavities in order to create a block-out, that will eliminate undercuts and increase thickness of residual walls.
Preparations were then finished and polished with fine grain burs(60 and 40 micron respectively). After removing rubber dam, complete arch impressions were taken with a polyether material followed by disinfecting the impressions for 10 min . Provisional restorations were placed with eugenol-free temporary cement . Dental impressions and photographs are sent to dental technician for FRCFPD fabrication.
FRC FDPs were made in one dental laboratory on the full arch plaster cast. The model was first isolated with two coats of isolation medium. One unidirectional pre-impregnated E-glass fibers (Vectris- Ivoclar Vivadent, Lienchestein) was used to reinforce the veneering composite. Each bundle consists of about 4000 glass fibers, with a diameter of 1.7 mm, embedded in a PMMA/bis-GMA matrix. Before the fibers were placed on the cast, a layer of composite was applied into the interproximal-occlusal box of the abutment teeth. The fiber bundle was placed in the bed of the flowable resin using metal hand instruments.
After photo-polymerization with a halogen polymerization unit (light output: 1200 mw/cm2), the framework was veneered with a resin composite An opaque resin was used in some cases to improve the optical properties. The veneering resin composite was built incrementally; the construction was polymerized for the final time with a heat-light polymerization oven.
In the second session, after rubber dam placement and removal of provisional restorations, the teeth were cleaned with a prophylaxis brush and pumice. After try-in of the FRCFPD to check proximal contacts and marginal fit, all adhesive surfaces of the restoration were sandblasted, and then cleaned with ethanol and air-dried.
The cementation surface of the FDP was treated with resin monomer of the corresponding resin cement using a micro brush (Heliobond Ivoclar Vivadent, liechtenstein). The resin was left unpolymerized, shielded from light, for at least 5 minutes to allow the resin to penetrate and activate the IPN-phase of the polymethacrylate polymer matrix of the FRC framework.
The tooth surface was prepared for adhesion by applying a three step etch and rinse adhesive. After removal of excess resin, all restorations were cemented using a resin cement Variolink II . light-cured for 40s on each surface (lingual, labial, mesial, distal) (Astralis 10, SN 018766, Ivoclar Vivadent, light output: 1200 mW/cm2). Static and dynamic occlusion was adjusted using fine grit diamond burs. The power output of the unit was measured with a radiometer ( before the placement of each restoration. After polymerization, restoration margins were finished. Occlusion was adjusted with fine diamond burs (60- and 40-µm grit) and finally, the restoration was polished with pointed silicon polishers and abrasive polishing brushes. Patients received individual instructions to maintain plaque control.
One operator applied all the restorations who has experience in adhesive dentistry (>10 years since graduation).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FRCFPDs | Other | Device: Fiber Reinforced Composite Fixed Partial DenturesFiber reenforced Composite Fixed Partial Dentures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All subjects were required to be at least 18 years old, able to read and sign the informed consent document
- Physically and psychologically able to tolerate conventional restorative procedures
- Having no active periodontal or pulpal diseases
- Having no primary caries
- Not allergic to resin-based materials
Key exclusion criteria (1 listed)
- Patients who had more absent teeth than the tooth to be replaced in the rest of the dentition or those having diastemas were not excluded.
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 |
|---|---|---|
| Fiber Reinforced Composite Fixed Partial DenturesAlso: FRCPDsAll restorations were made indirectly on a plaster model using unidirectional E-glass fibers (Vectris- Ivoclar Vivadent, , liechtenstein) in combination with a laboratory resin composite (Signum, Heraeus-Kulzer) | Device | FRCFPDs |
Primary outcome
Debonding of restoration
Time frame: 15 Years
According to USPHS criteria
Fracture of Tooth
Time frame: 15 Years
According to USPHS criteria
Fracture of Restorations
Time frame: 15 Years
According to USPHS criteria
Chipping of restoration
Time frame: 15 Years
According to USPHS criteria
1 secondary outcome
Secondary caries of the tooth
Time frame: 15 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber Reinforced Composite Fixed Partial Dentures in people with Prosthodontics E06.780, run by BNM Clinic and Research.
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 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: status not confirmed, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Debonding of restoration (time frame: 15 Years). The study lists 4 primary outcomes in all. 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 26 Jul 2016.