Guided Implant PlacementNCT07663045
Qualitative and Quantitative Assessment of Marginal Bone Loss Following Flapless Guided Versus Conventional Implant Placement
A study testing Conventional Flap Implant Placement and Flapless guided implant in people with Guided Implant Placement and Delayed Implant, run by Gulf Medical University at 1 site in United Arab Emirates.
Trial summary
Marginal bone preservation is an important determinant of long-term implant success. Conventional flap implant placement provides direct visualization of the surgical site but may disturb the periosteal blood supply and contribute to early crestal bone remodeling. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Guided Implant Placement, Delayed Implant, CBCT Segmentation
- What is being tested?
- Conventional Flap Implant Placement and Flapless guided implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Jul 2025to 30 Jul 2026
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 20 years or older.
- Patients requiring at least two dental implants within the same arch.
- Patients with good general health and able to undergo oral surgery.
- Patients willing to participate in the study and provide informed consent.
- Patients with adequate bone volume for implant placement as determined by preoperative radiographic assessment (e.g., cone beam computed tomography).
Who cannot join
- Patients with systemic diseases that could compromise healing or implant success (e.g., uncontrolled diabetes, immunocompromised conditions).
- Patients with a history of radiation therapy to the head and neck region.
- Patients with active periodontal disease or untreated oral infections.
- Patients who are pregnant or breastfeeding.
- Patients with a history of bisphosphonate therapy or other medications that may affect bone metabolism.
- Smoker Patients with a history of smoking or heavy alcohol consumption.
Show all 10Show fewer
- Patients with unrealistic expectations or inability to comply with postoperative care instructions.
- Patients with significant facial trauma or anatomical deformities affecting the implant site.
- Patient who requires Immediate implant placement
- Thin gingival biotype
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Gulf Medical University
Ajman, Ajman Emirate, 00000
About this study
Official title: Qualitative and Quantitative Assessment of Marginal Bone Loss Following Flapless Guided Versus Conventional Implant Placement Using Cone Beam Computed Tomography - A Split-Mouth Randomized Controlled Trial.
Marginal bone preservation is an important determinant of long-term implant success. Conventional flap implant placement provides direct visualization of the surgical site but may disturb the periosteal blood supply and contribute to early crestal bone remodeling.
Flapless guided implant placement is a minimally invasive approach that aims to preserve soft tissue architecture and vascular integrity. CBCT allows three-dimensional evaluation of peri implant bone levels, including mesial, distal, buccal, and lingual aspects.
Aim: The aim of this study was to compare flapless guided implant placement with conventional flap implant placement in terms of marginal bone loss, implant stability, postoperative pain, and soft-tissue healing.
- Conditions
- Guided Implant Placement, Delayed Implant, CBCT Segmentation
- Being tested
- Conventional Flap Implant Placement, Flapless guided implant
- Keywords
- CBCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Flap Implant PlacementProcedure or surgery
manually raising the gingival tissue during dental implant surgery, this surgical procedure involves the placement of a dental implant directly into the alveolar or basal bone during a single session followed by the placement of a healing abutment without the use of surgical guides or advanced technology.
Flapless guided implantProcedure or surgery
a minimally invasive dental implant procedure where a surgical guide, often created using advanced imaging techniques like cone-beam computed tomography (CBCT) and computer-aided design (CAD), directs the precise placement of dental implants without the need for traditional flap elevation.
| Study group | Role | What they receive |
|---|---|---|
| Flapless Guided Implant Placement | Experimental | Not described Receives: Procedure: Flapless guided implant |
| Conventional Flap Implant Placement | Experimental | Not described Receives: Procedure: Conventional Flap Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Loss
CBCT assessment
Measured: baseline, 3 months, 6 months
Secondary outcomes (2)
Implant Stability ISQ
Implant stability was assessed as a secondary outcome using Resonance Frequency Analysis (RFA), which provides an objective and non-invasive measurement of implant stability expressed as the Implant Stability Quotient (ISQ).
Measured: baseline, 3 months, 6 months
Postoperative Pain Assessment VAS scale 0-10
VAS scale 0-10
Measured: baseline, Day 2 Day 3 Day 4 Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Jul 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guided Implant PlacementStudies 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
- Randomised
- Intervention model
- Single group
- Model description
- Split mouth design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663045
- Sponsor's protocol ID
- AbdallahMDSperio
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative and Quantitative Assessment of Marginal Bone Loss Following Flapless Guided Versus Conventional Implant Placement Using Cone Beam Computed Tomography - A Split-Mouth Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07663045
- Acronym / sponsor ID
- AbdallahMDSperio
- Conditions
- Guided Implant Placement, Delayed Implant, CBCT Segmentation
- Keywords
- CBCT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 23 Jun 2026 (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.
Marginal bone preservation is an important determinant of long-term implant success. Conventional flap implant placement provides direct visualization of the surgical site but may disturb the periosteal blood supply and contribute to early crestal bone remodeling.
Flapless guided implant placement is a minimally invasive approach that aims to preserve soft tissue architecture and vascular integrity. CBCT allows three-dimensional evaluation of peri implant bone levels, including mesial, distal, buccal, and lingual aspects.
Aim: The aim of this study was to compare flapless guided implant placement with conventional flap implant placement in terms of marginal bone loss, implant stability, postoperative pain, and soft-tissue healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth design
| Arm | Type | Receives |
|---|---|---|
| Flapless Guided Implant Placement | Experimental | Procedure: Flapless guided implant |
| Conventional Flap Implant Placement | Experimental | Procedure: Conventional Flap Implant Placement |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 20 years or older.
- Patients requiring at least two dental implants within the same arch.
- Patients with good general health and able to undergo oral surgery.
- Patients willing to participate in the study and provide informed consent.
- Patients with adequate bone volume for implant placement as determined by preoperative radiographic assessment (e.g., cone beam computed tomography).
Key exclusion criteria (10 listed)
- Patients with systemic diseases that could compromise healing or implant success (e.g., uncontrolled diabetes, immunocompromised conditions).
- Patients with a history of radiation therapy to the head and neck region.
- Patients with active periodontal disease or untreated oral infections.
- Patients who are pregnant or breastfeeding.
- Patients with a history of bisphosphonate therapy or other medications that may affect bone metabolism.
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 |
|---|---|---|
| Conventional Flap Implant Placementmanually raising the gingival tissue during dental implant surgery, this surgical procedure involves the placement of a dental implant directly into the alveolar or basal bone during a single session followed by the placement of a healing abutment without the use of surgical guides or advanced technology. | Procedure or surgery | Conventional Flap Implant Placement |
| Flapless guided implanta minimally invasive dental implant procedure where a surgical guide, often created using advanced imaging techniques like cone-beam computed tomography (CBCT) and computer-aided design (CAD), directs the precise placement of dental implants without the need for traditional flap elevation. | Procedure or surgery | Flapless Guided Implant Placement |
Primary outcome
Marginal Bone Loss
Time frame: baseline, 3 months, 6 months
CBCT assessment
2 secondary outcomes
Implant Stability ISQ
Time frame: baseline, 3 months, 6 months
Postoperative Pain Assessment VAS scale 0-10
Time frame: baseline, Day 2 Day 3 Day 4 Day 5
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 23 Jun 2026.
- 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.
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 Conventional Flap Implant Placement and Flapless guided implant in people with Guided Implant Placement and Delayed Implant, run by Gulf Medical University at 1 site in United Arab Emirates.
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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. 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 United Arab Emirates. 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?
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?
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: baseline, 3 months, 6 months). 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 23 Jun 2026.