Occlusal TraumaNCT06159530
Effect Of Occlusal Materials Used For All On Four Mandibular Implant Prosthesis With PEEK Framework
A study testing dental implants, peek framework and visio-lign nano composite in people with Occlusal Trauma, run by Mansoura University at 1 site in Egypt.
Trial summary
This study was performed to compare between the effects of different occlusal materials used for all on four implant supported mandibular fixed prosthesis with PEEK framework. Methods of Evaluation 1- Occlusal force analysis using digital occlusal device (occluscan). Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Occlusal Trauma
- What is being tested?
- dental implants, peek framework and visio-lign nano composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2022to 10 Oct 2023
- 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 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1- lack of satisfaction of mandibular conventional dentures due to denture instability. 2- Atrophy of mandibular ridges with insufficient bone. 3- They were healthy, free from any systemic diseases relating to bone resorption. 4- All patients have sufficient inter-arch space >15 mm. 5- Maxillary and mandibular residual alveolar ridges covered by healthy non-inflamed mucosa with even compressibility. 6- Normal maxilla-mandibular relationship (class I Angle's classification). 7- All patients will have mandibular bone height not less than 8-10mm as verified by cone beam CT. 8- Sufficient inter-arch space not less than 23 mm as verified by tentative jaw relation. And restorative space not less than14 mm as verified by putty index technique.
Who cannot join
- 1- Systemic disorders affecting bone (such as uncontrolled diabetes mellitus and osteoporosis). 2- Local or general contraindication for surgical procedures. 3- History of chemotherapy or radiation therapy to the head and neck area. 4- Habits as heavy smoking and alcoholism. 5- Patients with T.M.J disorders or poor neuromuscular co-ordination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Occlusal Materials Used For All On Four Implant Supported Mandibular Fixed Prosthesis With PEEK Framework
This study was performed to compare between the effects of different occlusal materials used for all on four implant supported mandibular fixed prosthesis with PEEK framework.
Methods of Evaluation
1- Occlusal force analysis using digital occlusal device (occluscan).
The evaluation periods will be done at time of insertion (T0),6 month (T1),12 month(T2) and 18 month(T3) after framework insertion.
Read the detailed description
thirty completely edentulous patients will be selected for the study from the outpatient's clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University.
The patients will be selected according to the following criteria:
- lack of satisfaction of mandibular conventional dentures due to denture instability.
- Atrophy of mandibular ridges with insufficient bone.
- They were healthy, free from any systemic diseases relating to bone resorption.
- All patients have sufficient inter-arch space >15 mm.
- Maxillary and mandibular residual alveolar ridges covered by healthy non-inflamed mucosa with even compressibility.
- Normal maxilla-mandibular relationship (class I Angle's classification).
- All patients will have mandibular bone height not less than 8-10mm as verified by cone beam CT.
- Sufficient inter-arch space not less than 23 mm as verified by tentative jaw relation. And restorative space not less than14 mm as verified by putty index technique.
Exclusion criteria included:
1- Systemic disorders affecting bone (such as uncontrolled diabetes mellitus and osteoporosis).
2- Local or general contraindication for surgical procedures. 3- History of chemotherapy or radiation therapy to the head and neck area. 4- Habits as heavy smoking and alcoholism. 5- Patients with T.M.J disorders or poor neuromuscular co-ordination.
- For all patient's conventional complete denture will be constructed and adjusted for insertion and delivery.
- A cone beam C.T will be done for each patient to determine the bone quality and quantity.
- A surgical stent will be designed and fabricated to allow accurate implant placement of two axially placed anterior implants and two distally tilted posterior implants by about 30 degree to support mandibular overdenture.
- Surgical placement of implant fixtures on its sites will be done.
- Multiunit abutments were screwed to the distal implants.
- The conventional mandibular denture will be modified to act as immediate fixed prosthesis that replace lost teeth and gingival tissues.
- After three months, the Polyetheretherketone (PEEK) frame that connects the four implants will be constructed using digital scan and CAD CAM manufacturing.
- The milled frame was fixed to the metal caps using DTK cement
- The BioHPP framework will have prepared abutments projecting from it. After processing, the framework will be tried in patient mouth for passive fit.
- Wax interocclusal record was made to establish the occlusal relationship with opposing teeth. According to the artificial teeth, the patients will be divided into two groups:
- Group (I): PEEK framework veneered with nanocomposite resin(visio-lign)
- Group (II): PEEK framework veneered with zirconia
- The inner surface of the artificial teeth will be etched using hydrophosphoric acid then silane will be used and light cured resin cement will be used for cementation of the artificial teeth to the PEEK framework
- The occlusal scheme used with the opposing maxillary denture will be lingualized balanced occlusion to enhance the stability of mandibular implant overdentures.
Methods of evaluation:
1- Occlusal force analysis using digital occlusal device (occluscan).
The evaluation periods will be done at time of insertion (T0), 6 month (T1), 12 month (T2) and 18 month (T3) after framework insertion.
- Conditions
- Occlusal Trauma
- Being tested
- dental implants, peek framework, visio-lign nano composite, zirconia crowns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implantsProcedure or surgery
4 dental implants placed in the mandible according to all-on 4 concept
peek frameworkProcedure or surgery
peek framework screwed to multi-unit abutments of 4-implants
visio-lign nano compositeProcedure or surgery
peek framework veneered with nano composite (visio-lign) as an occlusal material
zirconia crownsProcedure or surgery
peek framework covered with zirconia crowns as an occlusal material
| Study group | Role | What they receive |
|---|---|---|
| PEEK framework veneered with nanocomposite resin(visio-lign) | Experimental | patients recieved 4 implants according to All on 4 concept then peek framework was delivered and veneered with nano-composite resin (visio-lign) as an occlusal material Receives: Procedure: dental implants; Procedure: peek framework; Procedure: visio-lign nano composite |
| PEEK framework veneered with zirconia crowns | Experimental | patients recieved 4 implants according to All on 4 concept then peek framework was delivered and veneered with zirconia crowns as an occlusal material Receives: Procedure: dental implants; Procedure: peek framework; Procedure: zirconia crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
occlusal stability
Occlusal stability using digital occlusal device (occlusense)
Measured: The evaluation periods will be done at time of insertion (T0), 6 month (T1), 12 month (T2) and 18 month (T3) after framework insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start20 Jan 2022
- Primary completion4 Sep 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occlusal TraumaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed shady, Mansoura University
- Investigators
- Mansoura U Faculty of dentistry, Principal investigator, Mansoura University Faculty of Dentistry, Prosthodontics department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159530
- Sponsor's protocol ID
- A03021121
- Status last verified
- Nov 2023
- First submitted
- 28 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Occlusal Materials Used For All On Four Implant Supported Mandibular Fixed Prosthesis With PEEK Framework
- ClinicalTrials.gov ID
- NCT06159530
- Acronym / sponsor ID
- A03021121
- Conditions
- Occlusal Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 6 Dec 2023 (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 study was performed to compare between the effects of different occlusal materials used for all on four implant supported mandibular fixed prosthesis with PEEK framework.
Methods of Evaluation
1- Occlusal force analysis using digital occlusal device (occluscan).
The evaluation periods will be done at time of insertion (T0),6 month (T1),12 month(T2) and 18 month(T3) after framework insertion.
Detailed description
thirty completely edentulous patients will be selected for the study from the outpatient's clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University.
The patients will be selected according to the following criteria:
- lack of satisfaction of mandibular conventional dentures due to denture instability.
- Atrophy of mandibular ridges with insufficient bone.
- They were healthy, free from any systemic diseases relating to bone resorption.
- All patients have sufficient inter-arch space >15 mm.
- Maxillary and mandibular residual alveolar ridges covered by healthy non-inflamed mucosa with even compressibility.
- Normal maxilla-mandibular relationship (class I Angle's classification).
- All patients will have mandibular bone height not less than 8-10mm as verified by cone beam CT.
- Sufficient inter-arch space not less than 23 mm as verified by tentative jaw relation. And restorative space not less than14 mm as verified by putty index technique.
Exclusion criteria included:
1- Systemic disorders affecting bone (such as uncontrolled diabetes mellitus and osteoporosis).
2- Local or general contraindication for surgical procedures. 3- History of chemotherapy or radiation therapy to the head and neck area. 4- Habits as heavy smoking and alcoholism. 5- Patients with T.M.J disorders or poor neuromuscular co-ordination.
- For all patient's conventional complete denture will be constructed and adjusted for insertion and delivery.
- A cone beam C.T will be done for each patient to determine the bone quality and quantity.
- A surgical stent will be designed and fabricated to allow accurate implant placement of two axially placed anterior implants and two distally tilted posterior implants by about 30 degree to support mandibular overdenture.
- Surgical placement of implant fixtures on its sites will be done.
- Multiunit abutments were screwed to the distal implants.
- The conventional mandibular denture will be modified to act as immediate fixed prosthesis that replace lost teeth and gingival tissues.
- After three months, the Polyetheretherketone (PEEK) frame that connects the four implants will be constructed using digital scan and CAD CAM manufacturing.
- The milled frame was fixed to the metal caps using DTK cement
- The BioHPP framework will have prepared abutments projecting from it. After processing, the framework will be tried in patient mouth for passive fit.
- Wax interocclusal record was made to establish the occlusal relationship with opposing teeth. According to the artificial teeth, the patients will be divided into two groups:
- Group (I): PEEK framework veneered with nanocomposite resin(visio-lign)
- Group (II): PEEK framework veneered with zirconia
- The inner surface of the artificial teeth will be etched using hydrophosphoric acid then silane will be used and light cured resin cement will be used for cementation of the artificial teeth to the PEEK framework
- The occlusal scheme used with the opposing maxillary denture will be lingualized balanced occlusion to enhance the stability of mandibular implant overdentures.
Methods of evaluation:
1- Occlusal force analysis using digital occlusal device (occluscan).
The evaluation periods will be done at time of insertion (T0), 6 month (T1), 12 month (T2) and 18 month (T3) after framework insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEK framework veneered with nanocomposite resin(visio-lign) | Experimental | Procedure: dental implants, Procedure: peek framework, Procedure: visio-lign nano compositepatients recieved 4 implants according to All on 4 concept then peek framework was delivered and veneered with nano-composite resin (visio-lign) as an occlusal material |
| PEEK framework veneered with zirconia crowns | Experimental | Procedure: dental implants, Procedure: peek framework, Procedure: zirconia crownspatients recieved 4 implants according to All on 4 concept then peek framework was delivered and veneered with zirconia crowns as an occlusal material |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1- lack of satisfaction of mandibular conventional dentures due to denture instability. 2- Atrophy of mandibular ridges with insufficient bone. 3- They were healthy, free from any systemic diseases relating to bone resorption. 4- All patients have sufficient inter-arch space >15 mm. 5- Maxillary and mandibular residual alveolar ridges covered by healthy non-inflamed mucosa with even compressibility. 6- Normal maxilla-mandibular relationship (class I Angle's classification). 7- All patients will have mandibular bone height not less than 8-10mm as verified by cone beam CT. 8- Sufficient inter-arch space not less than 23 mm as verified by tentative jaw relation. And restorative space not less than14 mm as verified by putty index technique.
Key exclusion criteria (1 listed)
- 1- Systemic disorders affecting bone (such as uncontrolled diabetes mellitus and osteoporosis). 2- Local or general contraindication for surgical procedures. 3- History of chemotherapy or radiation therapy to the head and neck area. 4- Habits as heavy smoking and alcoholism. 5- Patients with T.M.J disorders or poor neuromuscular co-ordination.
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 |
|---|---|---|
| dental implants4 dental implants placed in the mandible according to all-on 4 concept | Procedure or surgery | PEEK framework veneered with nanocomposite resin(visio-lign), PEEK framework veneered with zirconia crowns |
| peek frameworkpeek framework screwed to multi-unit abutments of 4-implants | Procedure or surgery | PEEK framework veneered with nanocomposite resin(visio-lign), PEEK framework veneered with zirconia crowns |
| visio-lign nano compositepeek framework veneered with nano composite (visio-lign) as an occlusal material | Procedure or surgery | PEEK framework veneered with nanocomposite resin(visio-lign) |
| zirconia crownspeek framework covered with zirconia crowns as an occlusal material | Procedure or surgery | PEEK framework veneered with zirconia crowns |
Primary outcome
occlusal stability
Time frame: The evaluation periods will be done at time of insertion (T0), 6 month (T1), 12 month (T2) and 18 month (T3) after framework insertion
Occlusal stability using digital occlusal device (occlusense)
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 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
Mansoura U Faculty of dentistry principal investigator
Mansoura University Faculty of Dentistry, Prosthodontics department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental implants, peek framework and visio-lign nano composite in people with Occlusal Trauma, run by Mansoura 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 1 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 6 Dec 2023. 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.
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?
occlusal stability (time frame: The evaluation periods will be done at time of insertion (T0), 6 month (T1), 12 month (T2) and 18 month (T3) after framework insertion). 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 Dec 2023.