Patient SatisfactionPhase 4NCT04914325
Patient Satisfaction , Marginal Adaptation And Biocompatibility of Milled Biohpp Polyetheretherketone (PEEK) Single Anterior Crowns Veneered With Two Different Techniques.
A Phase 4 study testing peek in people with Patient Satisfaction and Gingival Bleeding, run by Cairo University at 1 site in Egypt.
Trial summary
Research question For patients in a need for anterior crown, does the use of Milled BioHPP PEEK copings veneered with CAD/CAM composite resin offer better patient satisfaction, marginal adaptation and biocompatibility when compared Milled BioHPP PEEK copings veneered with manual layering? Statement of the problem PEEK… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Patient Satisfaction, Gingival Bleeding
- What is being tested?
- peek
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Oct 2021to 22 Jan 2024
- Phase
- Phase 4
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All subjects are required to be:
- From 18-50 years old, be able to read and sign the informed consent document.
- Have no active periodontal or pulpal diseases, have teeth with good restorations
- Psychologically and physically able to withstand conventional dental procedures
- Patients in a need for anterior crown.
- Able to return for follow-up examinations and evaluation -
Who cannot join
- Patient less than 18 or more than 50 years
- Patient with active resistant periodontal diseases
- Patients with poor oral hygiene and uncooperative patients
- Pregnant women
- Patients in the growth stage with partially erupted teeth
- Psychiatric problems or unrealistic expectations -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction , Marginal Adaptation And Biocompatibility of Milled Biohpp Polyetheretherketone (PEEK) Single Anterior Crowns Veneered With Two Different Techniques.(Randomized Controlled Clinical Trial)
Research question For patients in a need for anterior crown, does the use of Milled BioHPP PEEK copings veneered with CAD/CAM composite resin offer better patient satisfaction, marginal adaptation and biocompatibility when compared Milled BioHPP PEEK copings veneered with manual layering? Statement of the problem PEEK exhibits a unique modulus of elasticity close to human bone/dentine so it acts as a shock absorber with stress reducing effect. Moreover from a biologic point of view, PEEK is highly compatible with surrounding tissues and it has very promising surface properties . The use of peek in anterior area is limited due to its opaque nature and grayish color, this drawback has been overcome by the use of composite layering material . PEEK restorations can be veneered with manual or CAD/CAM techniques. Information is lacking regarding the influence of the veneering technique on the patient satisfaction , precision of fit and biocompatibility of these restorations which will in turn influence their performance in patient's satisfaction.
Rationale To achieve high esthetics when using PEEK it must be veneered by esthetic material 3 . It is available to be used manually or to be milled by CAD/CAM. The manual veneering of the PEEK coping with composite might affect the marginal integrity and the surrounding gingival tissues leading to decrease in the patient satisfaction, while the CAD/CAM veneering technique is proposed to have better patient satisfaction , marginal adaptation and an excellent biocompatible effect on the surrounding tissue. The importance of this trial lies in providing an alternative solution to the manual veneering technique, which will, in-turn, provide better restoration longevity results
Read more
Aim of the study:
The aim of this study is to evaluate the patient satisfaction ,marginal adaptation and biocompatibility of milled BioHPP PEEK copings veneered with CAD/CAM composite resin and compare them to milled BioHPP PEEK copings veneered with manual layering.
Null hypothesis:
There is no difference in the patient satisfaction, marginal adaptation and biocompatibility between milled BioHPP PEEK copings veneered with CAD/CAM composite resin and milled BioHPP PEEK copings veneered with manual layering.
Primary objective: - The Primary outcome: : patient satisfaction of the two groups will be assessed by rating score 0 unaccepted , 1 good , 2 excellent - Secondary outcome: Marginal adaptation of the two groups will be assessed using the modified Ryge criteria. - Tertiary outcome: Biocompatibility (Bleeding). Signs of inflammation and bleeding of the two groups will be recorded after clinical examination and probing using periodontal probe Trial design: - Randomized clinical trial
Eligibility criteria:
Inclusion criteria:
All subjects are required to be: 1-From 18-50 years old, be able to read and sign the informed consent document. 2- Have no active periodontal or pulpal diseases, have teeth with good restorations 3- Psychologically and physically able to withstand conventional dental procedures 4- Patients in a need for anterior crown. 5- Able to return for follow-up examinations and evaluation Exclusion criteria
- Patient less than 18 or more than 50 years 2. Patient with active resistant periodontal diseases 3. Patients with poor oral hygiene and uncooperative patients 4. Pregnant women 5. Patients in the growth stage with partially erupted teeth 6. Psychiatric problems or unrealistic expectations
Read the detailed description
Intervention: Examination and diagnosis: - Selection and examination of the patients according to inclusion and exclusion criteria. Diagnosis of the patients' chief complaint and teeth that will be involved in this study will be done then performing proper scaling and polishing procedure, Primary impression will be taken to produce study cast. The patients will be asked to maintain good oral hygiene measures by using tooth brush twice daily. - Taking a pre-operative professional photo, Tooth preparation procedure: Recording the sulcus depth and gingival condition prior to preparation, Conservative tooth preparation will be prepared after local anesthesia has been given as required., Full coverage preparation will be carried out , After tooth preparation, adequate 2ry Impression using non aqueous elastomeric impression materials and bite registration will be taken., Fabrication of the temporary restoration using composite resin temporary material and cemented using non Eugenol Zinc Oxide temporary cement, Fabrication and cementation of restoration: Bio-HPP will be supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered with two veneering techniques; the CAD/ CAM and the manual technique using the visio.lign system of appropriate shade. The finished Bio HPP crown will be cemented by adhesive resin cement according to manufacturer instruction, Criteria for discontinuing: Restoration will be removed when there are any signs of leakage, fracture or severe post-operative pain due to pulpal response and replaced by a temporary restoration cemented with Ca (OH) cement in order to alleviate pain, Strategies to improve adherence to intervention protocol: - ''In the first visit, a Face to Face adherence session will be held in which the patient should be informed about the study steps and how to maintain oral hygiene measures. Further sessions will occur at the follow-up visits.8 Participant patients will be asked about any problems they are having. Patients will be recalled every three months for one year for follow up visits. Permitted or prohibited interventions: Oral hygiene measures are permitted for enhanced results while using hard tooth brushes or abrasive containing tooth paste after intervention are prohibited.
- Conditions
- Patient Satisfaction, Gingival Bleeding
- Being tested
- peek
- Medical subject headings
- Patient Satisfaction, Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peekCombination product
After tooth preparation, adequate 2ry Impression using non aqueous elastomeric impression materials and bite registration will be taken. 5. Fabrication of the temporary restoration using composite resin temporary material and cemented using non Eugenol Zinc Oxide temporary cement. 11.a.iii. Fabrication and cementation of restoration: Bio-HPP will be supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered with two veneering techniques; the CAD/ CAM and the manual technique using the visio.lign system of appropriate shade. The finished Bio HPP crown will be cemented by adhesive resin cement according to manufacturer instruction
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm :copings veneered with CAD/CAM composite resin | Experimental | Not described Receives: Combination Product: peek |
| Control arm : copings veneered with manual layering | Active comparator | Not described Receives: Combination Product: peek |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction of the two groups will be assessed
rating score 0 unaccepted , 1 good , 2 excellent
Measured: one year
Secondary outcomes (1)
Marginal adaptation of the two groups will be assessed u
using the modified Ryge criteria/- Alpha (A) No visible evidences of crevice along the margins; no catch or penetration of the explorer.
- Bravo (B) Visible evidence of crevice and/or catch of explorer; no penetration of the explorer.
- Charlie (C) Visible evidence of crevice and penetration of the explorer
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start22 Oct 2021
- Primary completion22 Jan 2023
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1\. Recording the sulcus depth and gingival condition prior to preparation. 2. Conservative tooth preparation will be prepared after local anesthesia has been given as required. 3. Full coverage preparation will be carried out . 3. After tooth preparation, adequate 2ry Impression using non aqueous elastomeric impression materials and bite registration will be taken. 5. Fabrication of the temporary restoration using composite resin temporary material and cemented using non Eugenol Zinc Oxide temporary cement. 11.a.iii. Fabrication and cementation of restoration: Bio-HPP will be supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered with two veneering techniques; the CAD/ CAM and the manual technique using the visio.lign system of appropriate shade. The finished Bio HPP crown will be cemented by adhesive resin cement according to manufacturer instruction.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah Mohamed Qasem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914325
- Sponsor's protocol ID
- 241020
- Status last verified
- Feb 2024
- First submitted
- 22 May 2021
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Visit 1: Preoperative records, face-to-face adherence reminder session, clinical, radiographic examination, intraoral photographs and primary impression for diagnostic cast construction. Visit 2: Teeth preparation, secondary impression using addition silicone rubber base material† and temporary restoration. Visit 3: placement and temporary cementation of the interim restoration using temporary cement. Visit 4: try in of the coping. Visit 5: placement of final restoration Evaluation of the restoration immediately and follow up visit at (T0, T6, T12)
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction , Marginal Adaptation And Biocompatibility of Milled Biohpp Polyetheretherketone (PEEK) Single Anterior Crowns Veneered With Two Different Techniques.(Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04914325
- Acronym / sponsor ID
- 241020
- Conditions
- Patient Satisfaction, Gingival Bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 22 Jan 2023 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 4 Jun 2021 (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.
Research question For patients in a need for anterior crown, does the use of Milled BioHPP PEEK copings veneered with CAD/CAM composite resin offer better patient satisfaction, marginal adaptation and biocompatibility when compared Milled BioHPP PEEK copings veneered with manual layering? Statement of the problem PEEK exhibits a unique modulus of elasticity close to human bone/dentine so it acts as a shock absorber with stress reducing effect. Moreover from a biologic point of view, PEEK is highly compatible with surrounding tissues and it has very promising surface properties . The use of peek in anterior area is limited due to its opaque nature and grayish color, this drawback has been overcome by the use of composite layering material . PEEK restorations can be veneered with manual or CAD/CAM techniques. Information is lacking regarding the influence of the veneering technique on the patient satisfaction , precision of fit and biocompatibility of these restorations which will in turn influence their performance in patient's satisfaction.
Rationale To achieve high esthetics when using PEEK it must be veneered by esthetic material 3 . It is available to be used manually or to be milled by CAD/CAM. The manual veneering of the PEEK coping with composite might affect the marginal integrity and the surrounding gingival tissues leading to decrease in the patient satisfaction, while the CAD/CAM veneering technique is proposed to have better patient satisfaction , marginal adaptation and an excellent biocompatible effect on the surrounding tissue. The importance of this trial lies in providing an alternative solution to the manual veneering technique, which will, in-turn, provide better restoration longevity results
Aim of the study:
The aim of this study is to evaluate the patient satisfaction ,marginal adaptation and biocompatibility of milled BioHPP PEEK copings veneered with CAD/CAM composite resin and compare them to milled BioHPP PEEK copings veneered with manual layering.
Null hypothesis:
There is no difference in the patient satisfaction, marginal adaptation and biocompatibility between milled BioHPP PEEK copings veneered with CAD/CAM composite resin and milled BioHPP PEEK copings veneered with manual layering.
Primary objective: - The Primary outcome: : patient satisfaction of the two groups will be assessed by rating score 0 unaccepted , 1 good , 2 excellent - Secondary outcome: Marginal adaptation of the two groups will be assessed using the modified Ryge criteria. - Tertiary outcome: Biocompatibility (Bleeding). Signs of inflammation and bleeding of the two groups will be recorded after clinical examination and probing using periodontal probe Trial design: - Randomized clinical trial
Eligibility criteria:
Inclusion criteria:
All subjects are required to be: 1-From 18-50 years old, be able to read and sign the informed consent document. 2- Have no active periodontal or pulpal diseases, have teeth with good restorations 3- Psychologically and physically able to withstand conventional dental procedures 4- Patients in a need for anterior crown. 5- Able to return for follow-up examinations and evaluation Exclusion criteria
- Patient less than 18 or more than 50 years 2. Patient with active resistant periodontal diseases 3. Patients with poor oral hygiene and uncooperative patients 4. Pregnant women 5. Patients in the growth stage with partially erupted teeth 6. Psychiatric problems or unrealistic expectations
Detailed description
Intervention: Examination and diagnosis: - Selection and examination of the patients according to inclusion and exclusion criteria. Diagnosis of the patients' chief complaint and teeth that will be involved in this study will be done then performing proper scaling and polishing procedure, Primary impression will be taken to produce study cast. The patients will be asked to maintain good oral hygiene measures by using tooth brush twice daily. - Taking a pre-operative professional photo, Tooth preparation procedure: Recording the sulcus depth and gingival condition prior to preparation, Conservative tooth preparation will be prepared after local anesthesia has been given as required., Full coverage preparation will be carried out , After tooth preparation, adequate 2ry Impression using non aqueous elastomeric impression materials and bite registration will be taken., Fabrication of the temporary restoration using composite resin temporary material and cemented using non Eugenol Zinc Oxide temporary cement, Fabrication and cementation of restoration: Bio-HPP will be supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered with two veneering techniques; the CAD/ CAM and the manual technique using the visio.lign system of appropriate shade. The finished Bio HPP crown will be cemented by adhesive resin cement according to manufacturer instruction, Criteria for discontinuing: Restoration will be removed when there are any signs of leakage, fracture or severe post-operative pain due to pulpal response and replaced by a temporary restoration cemented with Ca (OH) cement in order to alleviate pain, Strategies to improve adherence to intervention protocol: - ''In the first visit, a Face to Face adherence session will be held in which the patient should be informed about the study steps and how to maintain oral hygiene measures. Further sessions will occur at the follow-up visits.8 Participant patients will be asked about any problems they are having. Patients will be recalled every three months for one year for follow up visits. Permitted or prohibited interventions: Oral hygiene measures are permitted for enhanced results while using hard tooth brushes or abrasive containing tooth paste after intervention are prohibited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. Recording the sulcus depth and gingival condition prior to preparation. 2. Conservative tooth preparation will be prepared after local anesthesia has been given as required. 3. Full coverage preparation will be carried out . 3. After tooth preparation, adequate 2ry Impression using non aqueous elastomeric impression materials and bite registration will be taken. 5. Fabrication of the temporary restoration using composite resin temporary material and cemented using non Eugenol Zinc Oxide temporary cement. 11.a.iii. Fabrication and cementation of restoration: Bio-HPP will be supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered with two veneering techniques; the CAD/ CAM and the manual technique using the visio.lign system of appropriate shade. The finished Bio HPP crown will be cemented by adhesive resin cement according to manufacturer instruction.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm :copings veneered with CAD/CAM composite resin | Experimental | Combination Product: peek |
| Control arm : copings veneered with manual layering | Active comparator | Combination Product: peek |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- From 18-50 years old, be able to read and sign the informed consent document.
- Have no active periodontal or pulpal diseases, have teeth with good restorations
- Psychologically and physically able to withstand conventional dental procedures
- Patients in a need for anterior crown.
- Able to return for follow-up examinations and evaluation -
Key exclusion criteria (6 listed)
- Patient less than 18 or more than 50 years
- Patient with active resistant periodontal diseases
- Patients with poor oral hygiene and uncooperative patients
- Pregnant women
- Patients in the growth stage with partially erupted teeth
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 |
|---|---|---|
| peekAfter tooth preparation, adequate 2ry Impression using non aqueous elastomeric impression materials and bite registration will be taken. 5. Fabrication of the temporary restoration using composite resin temporary material and cemented using non Eugenol Zinc Oxide temporary cement. 11.a.iii. Fabrication and cementation of restoration: Bio-HPP will be supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered with two veneering techniques; the CAD/ CAM and the manual technique using the visio.lign system of appropriate shade. The finished Bio HPP crown will be cemented by adhesive resin cement according to manufacturer instruction | Combination product | Control arm : copings veneered with manual layering, Intervention arm :copings veneered with CAD/CAM composite resin |
Primary outcome
patient satisfaction of the two groups will be assessed
Time frame: one year
rating score 0 unaccepted , 1 good , 2 excellent
1 secondary outcome
Marginal adaptation of the two groups will be assessed u
Time frame: one year
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 6 Feb 2024.
- Individual participant dataSharing planned: Yes. Visit 1: Preoperative records, face-to-face adherence reminder session, clinical, radiographic examination, intraoral photographs and primary impression for diagnostic cast construction. Visit 2: Teeth preparation, secondary impression using addition silicone rubber base material† and temporary restoration. Visit 3: placement and temporary cementation of the interim restoration using temporary cement. Visit 4: try in of the coping. Visit 5: placement of final restoration Evaluation of the restoration immediately and follow up visit at (T0, T6, T12)
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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.
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 Phase 4 study testing peek in people with Patient Satisfaction and Gingival Bleeding, run by Cairo 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 6 inclusion and 6 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 6 Feb 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
patient satisfaction of the two groups will be assessed (time frame: one year). 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 6 Feb 2024.