Edentulous Alveolar RidgeNCT06576778
The Effect of Fiber-Reinforced Composites on Quality of Life and Bone Height in Maxillary Implant Arches
A study testing PROVSIONALIZATION in people with Edentulous Alveolar Ridge, run by Cairo University.
Trial summary
The aim of this study is assessing the effect of provisionalization with a glass fiber composite framework on patients' quality of life and bone height changes before the insertion of a definitive PEKKTON framework of screw-retained maxillary implant-supported prosthesis at a one-year follow-up period. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- PROVSIONALIZATION
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Nov 2025
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Completely edentulous patients with Angle's Class I maxillomandibular relationship
- Age ranges from 40 to 65 years old.
- Adequate zone of keratinized attached mucosa (≥ 8mm) over the maxillary crest.
- Absence of any medical disorder that could complicate the surgical phase or affect osseointegration.
- The patient must have enough bone height for implants, a minimum length of bone
- 12 mm, and a minimum diameter of bone 6 mm.
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- Patients with good oral hygiene.
- Adequate inter arch space for screw-retained prosthesis.
- Absence of any intra-oral pathological condition.
Who cannot join
- • Patients with recent extraction (less than three months).
- Patients with an inflamed ridge or candida infection
- Patients with the flabby ridge.
- Para functional habits.
- Cancer patients receiving chemotherapy and/or radiotherapy.
- Patients with uncontrolled diabetes, assessed by measuring glycosylated hemoglobin (HbA1c ≥ 7)
- Potentially uncooperative patients who are not willing to go through the proposed interventions.
- Moderate-to-heavy daily smokers (more than ten per day)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact of Provisionalization Using Fiber-Reinforced Composite on the Quality of Life and Bone Height Changes in Maxillary Implant Supported Arches Restored by Final PEKKTON Frameworks: A Randomized Controlled Trial
The aim of this study is assessing the effect of provisionalization with a glass fiber composite framework on patients' quality of life and bone height changes before the insertion of a definitive PEKKTON framework of screw-retained maxillary implant-supported prosthesis at a one-year follow-up period.
Read the detailed description
- Patient grouping: Group I, (control): patients obtained an Implant-supported, full arch maxillary definitive prosthesis utilizing 6 implants, for constructing PEKKTON framework without provisionalization. Group II, (intervention): Patients obtained an Implant-supported full arch maxillary provisional prosthesis protocol utilizing 6 implants for constructing a resin glass fiber composite framework followed by a definitive PEKKTON framework.
- Preparation of a scan appliance:
- The patient's denture will be used as a scan appliance by the addition of radiopaque material to act as radiopaque markers over the polished surfaces of the prosthesis in a staggered pattern at different levels to the occlusal plane on the buccal, labial, and palatal flanges of the denture.
- Double scan protocol will be used in our study in which a cone beam conventional tomography (CBCT) images will be produced for each case. The first scan will be taken for the maxilla while the patient is wearing the maxillary denture with the radiopaque markers and biting over cotton rolls, the other scan is for the modified maxillary denture.
- Computer software (BlueSky Bio) was used to overlap the two scans on each other where the final file contained reformatted images in 3D bone model, and 3D radiographic modified denture guide model to construct the surgical guide.
- Virtual planning, surgical guide fabrication, and Implant placement
- The implant planning will be done using the BlueSky Bio software. The scan of the maxillary denture will be superimposed over that of the maxillary arch scan, using points over the radiopaque marker as alignment points, for proper orientation of the scan appliance.
- 6 Implant planning ( 3.7x12 for anterior segment and 4x10 for the posterior segment) will be placed in areas with high bone quality and quantity of bone and will be distributed according to AP spread.
- A surgical guide will be planned and then the 3D virtual guide will be exported as STL file to the 3D printing machine. The surgical guide will be fixed in place using three fixation screws; with an adequate distance from the planned implant drilling sites, two screws placed in the buccal shelf area on both sides and one screw in the midline to achieve a tripoding position.
- The 3D surgical guide will be provided with metal sleeves corresponding to the virtually planned drilling sites with the precise depth, angulation, mesiodistal and buccolingual positioning of each implant as planned during the computer simulation for accurate placement of the implants' osteotomies. The osteotomies will be drilled, and implants will be inserted.
- The Multi-unit abutments will be placed over the dental implants, the denture will be relieved and picked up with soft liner.
- All patients will be instructed about oral hygiene measures, a soft diet for 4 weeks after surgery, and antimicrobial prophylaxes (amoxicillin 500mg twice daily for 5 days starting 1 hour before surgery). Postsurgical analgesic treatment will be performed with ibuprofen 600mg twice daily.
- Prosthetic procedures:
After 1 Month:
Group I (control gp): patients obtained an Implant-supported, full arch maxillary prosthesis utilizing 6 implants, for constructing PEKKTON framework without provisionalization.
- Digital impressions Scan bodies will be tightened onto the multi-unit abutments and an intraoral digital impression will be made using an IOS system after one month of implant insertion.
- Verification jigs fabrication (digitally) The milled PMMA jig will be constructed and checked for passive seating on implants by verifying proper contact at the PMMA jig interface and the multi-unit abutments.
- Framework fabrication:
- The (PEKKTON) frameworks and teeth will be digitally designed according to implant location, crown height space, occlusion, and opposing dentition with the help of scan appliance wax up.
- The frameworks will be milled with the final material (PEKKTON) and teeth will be printed with temporary material (PMMA).
- First, the passive fit will be checked between frameworks and multi-unit abutments, and the occlusion of printed teeth by PMMA will be checked and tried intra-orally.
Accordingly, if the try-in is accepted, the assigned material (PMMA) will be milled and assembled to the framework.
Group two (intervention gp): will be rehabilitated by using a glass fiber composite as a temporary framework followed by PEKKTON definitive framework.
Framework fabrication:
- The glass fiber composite framework and PMMA teeth will be digitally designed according to implant location, crown height space, occlusion, and opposing complete denture with the help of scan appliance wax up.
- The framework will be placed over the multi-unit abutments intraorally, picked up on cylinder. The occlusion of printed teeth by PMMA will be checked and then cemented with the framework. Then the whole assembly will be removed from patient mouth.
- After one month, the printed composite framework with the printed PMMA teeth will be screwed intraorally.
- After four months of temporization, the definitive PEKKTON will be re-milled from the same scan and delivered to the patients with the milled teeth.
- These frameworks will be milled, the passive fit will be checked between frameworks and multi-unit abutments, and the occlusion of printed teeth by PMMA will be checked and tried intra-orally. If the try-in is accepted, the assigned material (PMMA) will be milled and assembled to the framework.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- PROVSIONALIZATION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROVSIONALIZATIONProcedure or surgery
glass fiber composite as a temporary framework followed by PEKKTON definitive framework.
| Study group | Role | What they receive |
|---|---|---|
| No Provisional Prosthesis (PEKKTON as Definitive Framework) | Active comparator | Implant-supported full arch maxillary prosthesis utilising 6 implants, for constructing PEKKTON framework without provisionalization. Receives: Procedure: PROVSIONALIZATION |
| Glass Fiber Reinforced Composite Framework for Provisionalization Then PEKKTON Framework | Experimental | Implant-supported full arch maxillary prosthesis utilising 6 implants, then Glass fiber composite as a temporary framework followed by PEKKTON definitive framework. Receives: Procedure: PROVSIONALIZATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health related to quality of life
A translated form from a validated questionnaire will be used to address the Egyptian population; all patients have to answer the same questionnaire. Each answer will be given a score from 0 to 4 where the lesser the score the better the quality of life, data will be collected, and privacy will be ensured.
Measured: 1 year
Secondary outcomes (1)
Bone height changes assessments
Digital periapical radiographs (Digora System) at the time of implant loading, three months, six-months, one year post-operatively will be done utilizing periapical radiographs following the standardized long cone paralleling technique and evaluated. For further standardization, the same x-ray machine will be used at 8 milliamperes and 70 kilovolts for 0.6 seconds with a focal film distance of 35 cm.
Marginal bone height changes around the implants will be evaluated using the measurement software system supplied with the Digora radiographs system.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group I, (control): patients obtained an Implant-supported, full arch maxillary definitive prosthesis utilizing 6 implants, for constructing PEKKTON framework without provisionalization. Group II, (intervention): Patients obtained an Implant-supported full arch maxillary provisional prosthesis protocol utilizing 6 implants for constructing a resin glass fiber composite framework followed by a definitive PEKKTON framework.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haydi Hesham Mohamed Issa, Cairo University
- Investigators
- Haydi Issa, PhD, Principal investigator, faculty of dentistry, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576778
- Sponsor's protocol ID
- 3 1 24
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 29 Aug 2024
- 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 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Provisionalization Using Fiber-Reinforced Composite on the Quality of Life and Bone Height Changes in Maxillary Implant Supported Arches Restored by Final PEKKTON Frameworks: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06576778
- Acronym / sponsor ID
- 3 1 24
- Conditions
- Edentulous Alveolar Ridge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 29 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.
The aim of this study is assessing the effect of provisionalization with a glass fiber composite framework on patients' quality of life and bone height changes before the insertion of a definitive PEKKTON framework of screw-retained maxillary implant-supported prosthesis at a one-year follow-up period.
Detailed description
- Patient grouping: Group I, (control): patients obtained an Implant-supported, full arch maxillary definitive prosthesis utilizing 6 implants, for constructing PEKKTON framework without provisionalization. Group II, (intervention): Patients obtained an Implant-supported full arch maxillary provisional prosthesis protocol utilizing 6 implants for constructing a resin glass fiber composite framework followed by a definitive PEKKTON framework.
- Preparation of a scan appliance:
- The patient's denture will be used as a scan appliance by the addition of radiopaque material to act as radiopaque markers over the polished surfaces of the prosthesis in a staggered pattern at different levels to the occlusal plane on the buccal, labial, and palatal flanges of the denture.
- Double scan protocol will be used in our study in which a cone beam conventional tomography (CBCT) images will be produced for each case. The first scan will be taken for the maxilla while the patient is wearing the maxillary denture with the radiopaque markers and biting over cotton rolls, the other scan is for the modified maxillary denture.
- Computer software (BlueSky Bio) was used to overlap the two scans on each other where the final file contained reformatted images in 3D bone model, and 3D radiographic modified denture guide model to construct the surgical guide.
- Virtual planning, surgical guide fabrication, and Implant placement
- The implant planning will be done using the BlueSky Bio software. The scan of the maxillary denture will be superimposed over that of the maxillary arch scan, using points over the radiopaque marker as alignment points, for proper orientation of the scan appliance.
- 6 Implant planning ( 3.7x12 for anterior segment and 4x10 for the posterior segment) will be placed in areas with high bone quality and quantity of bone and will be distributed according to AP spread.
- A surgical guide will be planned and then the 3D virtual guide will be exported as STL file to the 3D printing machine. The surgical guide will be fixed in place using three fixation screws; with an adequate distance from the planned implant drilling sites, two screws placed in the buccal shelf area on both sides and one screw in the midline to achieve a tripoding position.
- The 3D surgical guide will be provided with metal sleeves corresponding to the virtually planned drilling sites with the precise depth, angulation, mesiodistal and buccolingual positioning of each implant as planned during the computer simulation for accurate placement of the implants' osteotomies. The osteotomies will be drilled, and implants will be inserted.
- The Multi-unit abutments will be placed over the dental implants, the denture will be relieved and picked up with soft liner.
- All patients will be instructed about oral hygiene measures, a soft diet for 4 weeks after surgery, and antimicrobial prophylaxes (amoxicillin 500mg twice daily for 5 days starting 1 hour before surgery). Postsurgical analgesic treatment will be performed with ibuprofen 600mg twice daily.
- Prosthetic procedures:
After 1 Month:
Group I (control gp): patients obtained an Implant-supported, full arch maxillary prosthesis utilizing 6 implants, for constructing PEKKTON framework without provisionalization.
- Digital impressions Scan bodies will be tightened onto the multi-unit abutments and an intraoral digital impression will be made using an IOS system after one month of implant insertion.
- Verification jigs fabrication (digitally) The milled PMMA jig will be constructed and checked for passive seating on implants by verifying proper contact at the PMMA jig interface and the multi-unit abutments.
- Framework fabrication:
- The (PEKKTON) frameworks and teeth will be digitally designed according to implant location, crown height space, occlusion, and opposing dentition with the help of scan appliance wax up.
- The frameworks will be milled with the final material (PEKKTON) and teeth will be printed with temporary material (PMMA).
- First, the passive fit will be checked between frameworks and multi-unit abutments, and the occlusion of printed teeth by PMMA will be checked and tried intra-orally.
Accordingly, if the try-in is accepted, the assigned material (PMMA) will be milled and assembled to the framework.
Group two (intervention gp): will be rehabilitated by using a glass fiber composite as a temporary framework followed by PEKKTON definitive framework.
Framework fabrication:
- The glass fiber composite framework and PMMA teeth will be digitally designed according to implant location, crown height space, occlusion, and opposing complete denture with the help of scan appliance wax up.
- The framework will be placed over the multi-unit abutments intraorally, picked up on cylinder. The occlusion of printed teeth by PMMA will be checked and then cemented with the framework. Then the whole assembly will be removed from patient mouth.
- After one month, the printed composite framework with the printed PMMA teeth will be screwed intraorally.
- After four months of temporization, the definitive PEKKTON will be re-milled from the same scan and delivered to the patients with the milled teeth.
- These frameworks will be milled, the passive fit will be checked between frameworks and multi-unit abutments, and the occlusion of printed teeth by PMMA will be checked and tried intra-orally. If the try-in is accepted, the assigned material (PMMA) will be milled and assembled to the framework.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group I, (control): patients obtained an Implant-supported, full arch maxillary definitive prosthesis utilizing 6 implants, for constructing PEKKTON framework without provisionalization. Group II, (intervention): Patients obtained an Implant-supported full arch maxillary provisional prosthesis protocol utilizing 6 implants for constructing a resin glass fiber composite framework followed by a definitive PEKKTON framework.
| Arm | Type | Receives |
|---|---|---|
| No Provisional Prosthesis (PEKKTON as Definitive Framework) | Active comparator | Procedure: PROVSIONALIZATIONImplant-supported full arch maxillary prosthesis utilising 6 implants, for constructing PEKKTON framework without provisionalization. |
| Glass Fiber Reinforced Composite Framework for Provisionalization Then PEKKTON Framework | Experimental | Procedure: PROVSIONALIZATIONImplant-supported full arch maxillary prosthesis utilising 6 implants, then Glass fiber composite as a temporary framework followed by PEKKTON definitive framework. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • Completely edentulous patients with Angle's Class I maxillomandibular relationship
Key exclusion criteria (8 listed)
- • Patients with recent extraction (less than three months).
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 |
|---|---|---|
| PROVSIONALIZATIONglass fiber composite as a temporary framework followed by PEKKTON definitive framework. | Procedure or surgery | Glass Fiber Reinforced Composite Framework for Provisionalization Then PEKKTON Framework, No Provisional Prosthesis (PEKKTON as Definitive Framework) |
Primary outcome
Oral health related to quality of life
Time frame: 1 year
A translated form from a validated questionnaire will be used to address the Egyptian population; all patients have to answer the same questionnaire. Each answer will be given a score from 0 to 4 where the lesser the score the better the quality of life, data will be collected, and privacy will be ensured.
1 secondary outcome
Bone height changes assessments
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Haydi Issa, PhD principal investigator
faculty of dentistry, Cairo University, Egypt
Questions about this trial
What is this clinical trial studying?
A study testing PROVSIONALIZATION in people with Edentulous Alveolar Ridge, run by Cairo University.
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 9 inclusion and 8 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 Aug 2024. 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?
Contact Cheta (+201224552363, nora.sheta@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral health related to quality of life (time frame: 1 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 29 Aug 2024.