Partial-edentulismNCT06628492
Surgical Guided Fabricated From Two Different Printing Materials
A study testing stainless steel printed surgical guide and resin printed surgical guide in people with Partial-edentulism, run by Suez Canal University.
Trial summary
implant will be inserted in patients with kennedy class 3 or 4 partially edentulous mandible .the implants will be inserted using teeth supported surgical guide fabricated from two different materials Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Partial-edentulism
- What is being tested?
- stainless steel printed surgical guide and resin printed surgical guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Nov 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with skeletal Angle´s class I maxilla-mandibular relationship,
- adequate inter-arch distance, have Kennedy class 3 or 4 partially edentulous mandible of more than 2 teeth missed and will be applied for the treatment of tooth loss and requiring fixed prosthodontic rehabilitation
- normal Physical and psychological status to tolerate conventional implant procedures,
- Their residual ridge had sufficient bone volume for implant installation and was covered by firm mucoperiosteum.
Who cannot join
- Smokers.
- Patients undergoing chemotherapy or radiotherapy and immunocompromised patients.
- Patients with, systemic disease that might complicate post-operative healing or contribute to bone resorption, e.g uncontrolled diabetes, psychological disorders, or alcohol, tobacco, or drug abuse
- parafunctional habits, poor oral hygiene, limited mouth opening, severe alveolar bone deficiencies,
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Assessment for the Positional Accuracy of Dental Implants Inserted by Computerized Surgical Guides Fabricated From Different Printing Materials
implant will be inserted in patients with kennedy class 3 or 4 partially edentulous mandible .the implants will be inserted using teeth supported surgical guide fabricated from two different materials
- Conditions
- Partial-edentulism
- Being tested
- stainless steel printed surgical guide, resin printed surgical guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stainless steel printed surgical guideDevice
the patient will wear the stainless steel surgical guide for the insertion of one implant
resin printed surgical guideDevice
the patient will wear the resin surgical guide for insertion of adjacent another implant implant
| Study group | Role | What they receive |
|---|---|---|
| group A implant inserted by stainless steel surgical guide | Experimental | Not described Receives: Device: stainless steel printed surgical guide |
| group B implant inserted by resin surgical guide | Active comparator | Not described Receives: Device: resin printed surgical guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
linear deviation of inserted implant
coronal and apical deviation of inserted implant from virtually planned one in millimeter.
Measured: 1 month
angular deviation of inserted implant
angular deviation of inserted implant from virtually planned one in angles.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial-edentulismStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628492
- Sponsor's protocol ID
- 802/2024
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment for the Positional Accuracy of Dental Implants Inserted by Computerized Surgical Guides Fabricated From Different Printing Materials
- ClinicalTrials.gov ID
- NCT06628492
- Acronym / sponsor ID
- 802/2024
- Conditions
- Partial-edentulism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 8 Oct 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.
implant will be inserted in patients with kennedy class 3 or 4 partially edentulous mandible .the implants will be inserted using teeth supported surgical guide fabricated from two different materials
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A implant inserted by stainless steel surgical guide | Experimental | Device: stainless steel printed surgical guide |
| group B implant inserted by resin surgical guide | Active comparator | Device: resin printed surgical guide |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with skeletal Angle´s class I maxilla-mandibular relationship,
- adequate inter-arch distance, have Kennedy class 3 or 4 partially edentulous mandible of more than 2 teeth missed and will be applied for the treatment of tooth loss and requiring fixed prosthodontic rehabilitation
- normal Physical and psychological status to tolerate conventional implant procedures,
- Their residual ridge had sufficient bone volume for implant installation and was covered by firm mucoperiosteum.
Key exclusion criteria (4 listed)
- Smokers.
- Patients undergoing chemotherapy or radiotherapy and immunocompromised patients.
- Patients with, systemic disease that might complicate post-operative healing or contribute to bone resorption, e.g uncontrolled diabetes, psychological disorders, or alcohol, tobacco, or drug abuse
- parafunctional habits, poor oral hygiene, limited mouth opening, severe alveolar bone deficiencies,
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 |
|---|---|---|
| stainless steel printed surgical guidethe patient will wear the stainless steel surgical guide for the insertion of one implant | Device | group A implant inserted by stainless steel surgical guide |
| resin printed surgical guidethe patient will wear the resin surgical guide for insertion of adjacent another implant implant | Device | group B implant inserted by resin surgical guide |
Primary outcome
linear deviation of inserted implant
Time frame: 1 month
coronal and apical deviation of inserted implant from virtually planned one in millimeter.
angular deviation of inserted implant
Time frame: 1 month
angular deviation of inserted implant from virtually planned one in angles.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing stainless steel printed surgical guide and resin printed surgical guide in people with Partial-edentulism, run by Suez Canal 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ahmed m hebeshi, Phd (00201282531256, ahmed_hebeshi@dent.auez.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
linear deviation of inserted implant (time frame: 1 month). The study lists 2 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 8 Oct 2024.