Dental Implantdental implantNCT06204692
Computer Guided Versus Freehand Dental Implant Surgery
A study testing dental implant in people with Dental Implant, run by October 6 University at 1 site in Egypt.
Trial summary
This study's goal is to evaluate the efficacy of traditional rehabilitation with freehand implant implantation of partly or totally edentulous patients utilizing flapless or mini-flap procedures vs. 3D implant design software and specialized surgical templates. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- dental implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 28 Sep 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- totally edentulous in one or both arches,
- with at least 7 mm of height and 4 mm of breadth in their bones as assessed by preoperative CBCT scans.
- patients between the ages of 35 and 65 who could give informed permission,
- Implants next to each other required to be positioned at least 3 mm apart from each other and 1.5 mm apart from the tooth.
Who cannot join
- Patients who have received radiation therapy to the head and neck region within the year prior to implantation,
- those who are receiving intravenous amino bisphosphonates,
- those who have untreated periodontitis,
- those with uncontrolled diabetes,
- pregnant women, or nursing mothers are among the general contraindications to implant surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computer Guided Versus Freehand Dental Implant Surgery: Randomized Controlled Clinical Trial
This study's goal is to evaluate the efficacy of traditional rehabilitation with freehand implant implantation of partly or totally edentulous patients utilizing flapless or mini-flap procedures vs. 3D implant design software and specialized surgical templates.
Read the detailed description
Patients with at least 7 mm of height and 4 mm of breadth in their bones, who needed at least two implants to be restored with a single prosthesis, were recruited one after the other. Patients were randomly assigned to two groups in a parallel group trial design. : Group I: consisted of 6 patients where computer guided dental implant placement and Group II: included six people who had dental implants placed manually. A temporary prosthesis was inserted into the implants right away, and four to six months later, a permanent prosthesis took its place.
Implant failures, marginal bone loss, number of therapy sessions, length of treatment, post-surgical pain and swelling, use of painkillers, surgical time, time needed to resolve problems, and patient satisfaction were among the outcome variables evaluated by a blinded, independent assessor. Patients were tracked for a full year.
- Conditions
- Dental Implant
- Being tested
- dental implant
- Keywords
- virtual planning;, computer guided implants;, freehand implant;, dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implantProcedure or surgery
consisted of 6 patients where computer guided dental implant placement
| Study group | Role | What they receive |
|---|---|---|
| Computer Guided Dental Implant Surgery. | Other | Computer Guided Dental Implant Surgery Receives: Procedure: dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal bone loss
Cone Beam Computed Tomography
Measured: 6 months postoperative
Secondary outcomes (1)
post-surgical pain and swelling
Visual Analog Scale (10 represent maximum pain , 0 represent no pain)
Measured: 7 days prior to implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Jun 2022
- Primary completion30 Jun 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermine Ramadan Mahmoud, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204692
- Sponsor's protocol ID
- RECO6U/29-2022
- Other IDs
- October6U
- Acronym
- dental implant
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Guided Versus Freehand Dental Implant Surgery: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06204692
- Acronym / sponsor ID
- dental implant / RECO6U/29-2022
- Conditions
- Dental Implant
- Keywords
- virtual planning;, computer guided implants;, freehand implant;, dental implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 12 Jan 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.
This study's goal is to evaluate the efficacy of traditional rehabilitation with freehand implant implantation of partly or totally edentulous patients utilizing flapless or mini-flap procedures vs. 3D implant design software and specialized surgical templates.
Detailed description
Patients with at least 7 mm of height and 4 mm of breadth in their bones, who needed at least two implants to be restored with a single prosthesis, were recruited one after the other. Patients were randomly assigned to two groups in a parallel group trial design. : Group I: consisted of 6 patients where computer guided dental implant placement and Group II: included six people who had dental implants placed manually. A temporary prosthesis was inserted into the implants right away, and four to six months later, a permanent prosthesis took its place.
Implant failures, marginal bone loss, number of therapy sessions, length of treatment, post-surgical pain and swelling, use of painkillers, surgical time, time needed to resolve problems, and patient satisfaction were among the outcome variables evaluated by a blinded, independent assessor. Patients were tracked for a full year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computer Guided Dental Implant Surgery. | Other | Procedure: dental implantComputer Guided Dental Implant Surgery |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- totally edentulous in one or both arches,
- with at least 7 mm of height and 4 mm of breadth in their bones as assessed by preoperative CBCT scans.
- patients between the ages of 35 and 65 who could give informed permission,
- Implants next to each other required to be positioned at least 3 mm apart from each other and 1.5 mm apart from the tooth.
Key exclusion criteria (5 listed)
- Patients who have received radiation therapy to the head and neck region within the year prior to implantation,
- those who are receiving intravenous amino bisphosphonates,
- those who have untreated periodontitis,
- those with uncontrolled diabetes,
- pregnant women, or nursing mothers are among the general contraindications to implant surgery.
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 implantconsisted of 6 patients where computer guided dental implant placement | Procedure or surgery | Computer Guided Dental Implant Surgery. |
Primary outcome
marginal bone loss
Time frame: 6 months postoperative
Cone Beam Computed Tomography
1 secondary outcome
post-surgical pain and swelling
Time frame: 7 days prior to implant placement
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 12 Jan 2024.
Related trials for Dental Implant
Recruiting
Dental Implant Healing With TNF-Alpha Inhibitors
Dental Implants, TNF-alpha Inhibitors
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Recruiting
Evaluation of Different Grafting Technique of Thin Gingival Phenotype With Delayed Dental Implants
Implant Dentistry, Connective Tissue Graft
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Not yet recruitingPhase 1/2
Effect of Povidone Iodine on the Dental Implant Internal Surface Microbiome
Dental Implant
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 dental implant in people with Dental Implant, run by October 6 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 4 inclusion and 5 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 12 Jan 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.
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?
marginal bone loss (time frame: 6 months postoperative). 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 12 Jan 2024.