Denture, Partial, Fixed, Resin-BondedNCT04491097
Clinical Outcomes of CAD/CAM Single-Retainer Monolithic Zirconia Ceramic Resin-Bonded Fixed Dentures Bonded With Two Different Resin Cements
A study testing Panavia V5 resin cement and Panavia F2.0 resin cement in people with Denture, Partial, Fixed, Resin-Bonded and Tooth Loss / Rehabilitation, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Congenitally missing tooth is one of the most common anomalies in human dentition. The treatment options of lateral incisor agenesis are closing the space with orthodontic treatment, implant treatment, conventional fixed dental prosthesis (FDPs) and resin-bonded fixed dentures (RBFDs). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Denture, Partial, Fixed, Resin-Bonded, Tooth Loss / Rehabilitation, Resin Cements
- What is being tested?
- Panavia V5 resin cement and Panavia F2.0 resin cement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2017to Feb 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 18 to 80 years
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participating in the study voluntarily
- Horizontal mobility of central incisors ≤1 mm
- Central incisors with healthy alveolar bone
- 1-1,5 mm overjet
- Having a good anterior guidance
Who cannot join
- Patients with gingivitis or periodontitis Poor oral hygiene Central incisors with endodontic treatment or periapical disease Central teeth with large fillings or loss of dental structure on the cementation surface Bad oral habits Patients with clinical symptoms of bruxism
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University School of Dentistry
Istanbul, 34083
About this study
Congenitally missing tooth is one of the most common anomalies in human dentition. The treatment options of lateral incisor agenesis are closing the space with orthodontic treatment, implant treatment, conventional fixed dental prosthesis (FDPs) and resin-bonded fixed dentures (RBFDs). RBFDs are used frequently for single tooth absence in the anterior region due to their minimal invasive properties, high clinical success and patient satisfaction. With the development of new and stronger materials, RBFDs with metal framework have been replaced by glass ceramic, lithium disilicate, fiber-reinforced composite (FRC) and zirconia. The aim of this study is to evaluate the clinical performance of CAD/CAM single-retainer monolithic zirconia ceramic RBFDs which cemented with two different resin cements.
Read the detailed description
The aim of this study is to evaluate the clinical performance of CAD/CAM single-retainer monolithic zirconia ceramic RBFDs which cemented with two different resin cements.
The project includes 20 patients. Most of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. The patients were selected from individuals who have unilateral or bilateral congenitally missing maxillary lateral teeth and wanted to be treated a restoration or undergoing orthodontic treatment.
After giving their consent to take part in the study no preparations were made on abutment teeth for RBFDs. Digital impressions were taken with an intraoral digital scanner. The RBFDs were designed using a CAD software, milled and presintered zirconia blocks (KatanaTM Zirconia HT, Kuraray Noritake Dental Inc, Tokyo, Japan). RBFD was adhesively bonded to abutment teeth with one of the two different resin cements (Panavia F2.0 or Panavia V5).
The control procedure is:
The restoration is evaluated according to presence of mobility or debonding and fracture at the connector area. Gingival harmony and periodontal tissues around the restorations were also examined. Mobility of the abutment tooth was checked in the clinical examination and alveolar bone was examined with periapical x-ray. The controls will take place after two weeks, one year, two years, three years and five years.
- Being tested
- Panavia V5 resin cement, Panavia F2.0 resin cement
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panavia V5 resin cementDevice
Missing lateral incisor teeth will be restored by zirconia ceramic RBFDs and adhesively bonded with Panavia V5 resin cement.The preperation and restoration of the tooth will be done according to to the guidelines for ordinary prosthetic techniques.
Panavia F2.0 resin cementDevice
Missing lateral incisor teeth will be restored by zirconia ceramic RBFDs and adhesively bonded with Panavia F2.0 resin cement.The preperation and restoration of the tooth will be done according to to the guidelines for ordinary prosthetic techniques.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Panavia V5 resin cement | Experimental | Resin cement with non-MDP monomer Receives: Device: Panavia V5 resin cement |
| Experimental: Panavia F2.0 resin cement | Active comparator | Resin cement with MDP monomer Receives: Device: Panavia F2.0 resin cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate of zirconia ceramic RBFDs
The survival was evaluated as described in the studies of Chai et al. (1). They described the survival as "the period of time starting at the cementation of the restoration and ending when the restoration was shown to have irreparably failed". The fracture was evaluated according to the study of Heintze and Rousson (2). They made a classification for fracture of zirconia restorations. Three grades of fracture treatment were assigned to this classification:
(1) Grade 1: Fracture surfaces were polished. (2) Grade 2: Fracture surfaces were repaired with resin-based composite. (3) Grade 3: Severe chipping fractures required replacement of affected prostheses.
- Chai J, Chu FC, Newsome PR, et al: Retrospective survival analysis of 3-unit fixed-fixed and 2-unit cantilevered fixed partial dentures. J Oral Rehabil 2005;32:759-765
- Heintze SD, Rousson V. Survival of zirconia- and metal-supported fixed dental prostheses: a systematic review. Int J Prosthodont 2010;23:493-502
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Jun 2017
- Primary completionAug 2022 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denture, Partial, Fixed, Resin-BondedStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kuraray Noritake Dental Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491097
- Sponsor's protocol ID
- 10840098-604.01.01-E14107
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of CAD/CAM Single-Retainer Monolithic Zirconia Ceramic Resin-Bonded Fixed Dentures Bonded With Two Different Resin Cements
- ClinicalTrials.gov ID
- NCT04491097
- Acronym / sponsor ID
- 10840098-604.01.01-E14107
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Kuraray Noritake Dental Inc.
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 29 Jul 2020 (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.
Congenitally missing tooth is one of the most common anomalies in human dentition. The treatment options of lateral incisor agenesis are closing the space with orthodontic treatment, implant treatment, conventional fixed dental prosthesis (FDPs) and resin-bonded fixed dentures (RBFDs). RBFDs are used frequently for single tooth absence in the anterior region due to their minimal invasive properties, high clinical success and patient satisfaction. With the development of new and stronger materials, RBFDs with metal framework have been replaced by glass ceramic, lithium disilicate, fiber-reinforced composite (FRC) and zirconia. The aim of this study is to evaluate the clinical performance of CAD/CAM single-retainer monolithic zirconia ceramic RBFDs which cemented with two different resin cements.
Detailed description
The aim of this study is to evaluate the clinical performance of CAD/CAM single-retainer monolithic zirconia ceramic RBFDs which cemented with two different resin cements.
The project includes 20 patients. Most of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. The patients were selected from individuals who have unilateral or bilateral congenitally missing maxillary lateral teeth and wanted to be treated a restoration or undergoing orthodontic treatment.
After giving their consent to take part in the study no preparations were made on abutment teeth for RBFDs. Digital impressions were taken with an intraoral digital scanner. The RBFDs were designed using a CAD software, milled and presintered zirconia blocks (KatanaTM Zirconia HT, Kuraray Noritake Dental Inc, Tokyo, Japan). RBFD was adhesively bonded to abutment teeth with one of the two different resin cements (Panavia F2.0 or Panavia V5).
The control procedure is:
The restoration is evaluated according to presence of mobility or debonding and fracture at the connector area. Gingival harmony and periodontal tissues around the restorations were also examined. Mobility of the abutment tooth was checked in the clinical examination and alveolar bone was examined with periapical x-ray. The controls will take place after two weeks, one year, two years, three years and five years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Panavia V5 resin cement | Experimental | Device: Panavia V5 resin cementResin cement with non-MDP monomer |
| Experimental: Panavia F2.0 resin cement | Active comparator | Device: Panavia F2.0 resin cementResin cement with MDP monomer |
Who may qualify
- Ages
- 18 to 80 years
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participating in the study voluntarily
- Horizontal mobility of central incisors ≤1 mm
- Central incisors with healthy alveolar bone
- 1-1,5 mm overjet
- Having a good anterior guidance
Key exclusion criteria (1 listed)
- Patients with gingivitis or periodontitis Poor oral hygiene Central incisors with endodontic treatment or periapical disease Central teeth with large fillings or loss of dental structure on the cementation surface Bad oral habits Patients with clinical symptoms of bruxism
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 |
|---|---|---|
| Panavia V5 resin cementMissing lateral incisor teeth will be restored by zirconia ceramic RBFDs and adhesively bonded with Panavia V5 resin cement.The preperation and restoration of the tooth will be done according to to the guidelines for ordinary prosthetic techniques. | Device | Experimental: Panavia V5 resin cement |
| Panavia F2.0 resin cementMissing lateral incisor teeth will be restored by zirconia ceramic RBFDs and adhesively bonded with Panavia F2.0 resin cement.The preperation and restoration of the tooth will be done according to to the guidelines for ordinary prosthetic techniques. | Device | Experimental: Panavia F2.0 resin cement |
Primary outcome
Survival rate of zirconia ceramic RBFDs
Time frame: 5 years
The survival was evaluated as described in the studies of Chai et al. (1). They described the survival as "the period of time starting at the cementation of the restoration and ending when the restoration was shown to have irreparably failed". The fracture was evaluated according to the study of Heintze and Rousson (2). They made a classification for fracture of zirconia restorations. Three grades of fracture treatment were assigned to this classification: (1) Grade 1: Fracture surfaces were polished. (2) Grade 2: Fracture surfaces were repaired with resin-based composite. (3) Grade 3: Severe chipping fractures required replacement of affected prostheses. 1. Chai J, Chu FC, Newsome PR, et al: Retrospective survival analysis of 3-unit fixed-fixed and 2-unit cantilevered fixed partial dentures. J Oral Rehabil 2005;32:759-765 2. Heintze SD, Rousson V. Survival of zirconia- and metal-supported fixed dental prostheses: a systematic review. Int J Prosthodont 2010;23:493-502
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panavia V5 resin cement and Panavia F2.0 resin cement in people with Denture, Partial, Fixed, Resin-Bonded and Tooth Loss / Rehabilitation, run by Istanbul Medipol University Hospital 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 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 29 Jul 2020. 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?
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?
Survival rate of zirconia ceramic RBFDs (time frame: 5 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 29 Jul 2020.