IMPLANTATIONPhase 2NCT07008079
Flapless Mini-incision Implant Surgery
A Phase 2 study testing Flapless punch, Flapless mini-incision and Conventional flap in people with IMPLANTATION and Dental Implant, run by Alaa Emara at 1 site in Saudi Arabia.
Trial summary
evaluate the clinical efficacy of the flapless mini-incision method compared to conventional flap and flapless punch methods Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- IMPLANTATION, Dental Implant, Dental Implant Placement
- What is being tested?
- Flapless punch, Flapless mini-incision and Conventional flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 16 Jun 2025to 31 Jul 2025
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with adequate bone height and width at the site of implant 120 placement, and good quality bone to support a primary stability of at least 30 Ncm and D2 bone quality according to Lekholm and Zarb classification), based on preoperative radiographic assessment
- Clinical evidence of optimal periodontal health with no active periodontal disease in adjacent teeth
- No history of systemic illnesses that could affect bone health and wound heal- ing (e.g. uncontrolled diabetes mellitus, osteoporosis, renal osteodystrophy…etc.)
- No history of or requirement for bone grafting and augmentation at the implant site
- Willingness to participate in the study and attend prescribed follow-up appointments
Who cannot join
- Patients with history of radiation therapy for head and neck cancer
- Patients with history of allergy and hypersensitivity to local anesthetic agents, and biomaterials used in dental implants
- Pregnant women and lactating mothers
- History of smoking (>2 cigarettes per day)
- Patients under treatment with anti-resorptive or anti-neoplastic medication such as bisphosphonates, chemotherapeutic agents, and monoclonal antibodies (e.g. Denosumab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flapless Mini-incision Implant Surgery vs Conventional Flap or Flapless Implant Surgery: A Prospective, Randomized, Single Blind, Clinical and Radiographic Study
evaluate the clinical efficacy of the flapless mini-incision method compared to conventional flap and flapless punch methods
- Being tested
- Flapless punch, Flapless mini-incision, Conventional flap
- Keywords
- flapless surgery, mini-incision surgery, peri-implant soft tissue, dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flapless punchProcedure or surgery
use of flapless puch surgery to place dental implants
Flapless mini-incisionProcedure or surgery
Use of a flapless mini-incision to place a dental implant
Conventional flapProcedure or surgery
Use of a conventional surgical flap to place a dental implant
| Study group | Role | What they receive |
|---|---|---|
| Conventional flap | Active comparator | The Standard commonly used surgical flap is used to place the dental implant Receives: Procedure: Conventional flap |
| Flapless punch | Experimental | A flapless punch is used to place the dental implants Receives: Procedure: Flapless punch |
| Flapless mini-incision | Experimental | A flapless mini incision is used to place the dental implants Receives: Procedure: Flapless mini-incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Assessment of patient's pain level using Visual Analog Scale (VAS) which would be compared between groups.
VAS is a visual scale 0 to 10 with 10 the highest pain score and 0 the lowest, the patient is asked to identify the pain level at the different timestops for comparison between groups
Measured: 18 months postoperatively
Secondary outcomes (2)
Soft-tissue healing
Assess the healing of overlaying soft tissue. Check for signs of infection , swelling, dehiscnce or inflammation
Measured: 18 months postoperatively
Radiographic bone level
Assessment of bone level postoperatively. A CBCT is ordered to assess bone density in hounsfeld unitsto assess level of bone maturation. This would then be compared across groups and between different time points to show bone deposition and healing.
Measured: 18 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start16 Jun 2025
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IMPLANTATIONStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaa Emara
- Sponsor type
- University, hospital or other
- Collaborators
- King Saud University
- Responsible party
- Sponsor-investigator, Alaa Emara, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008079
- Sponsor's protocol ID
- Flapless mini-incision implant
- Status last verified
- Sep 2026
- First submitted
- 19 May 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We might be sharing our data when needed according to the case
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flapless Mini-incision Implant Surgery vs Conventional Flap or Flapless Implant Surgery: A Prospective, Randomized, Single Blind, Clinical and Radiographic Study
- ClinicalTrials.gov ID
- NCT07008079
- Acronym / sponsor ID
- Flapless mini-incision implant
- Keywords
- flapless surgery, mini-incision surgery, peri-implant soft tissue, dental implant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Alaa EmaraUniversity, hospital or other
- Collaborators
- King Saud University
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 6 Jun 2025 (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.
evaluate the clinical efficacy of the flapless mini-incision method compared to conventional flap and flapless punch methods
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional flap | Active comparator | Procedure: Conventional flapThe Standard commonly used surgical flap is used to place the dental implant |
| Flapless punch | Experimental | Procedure: Flapless punchA flapless punch is used to place the dental implants |
| Flapless mini-incision | Experimental | Procedure: Flapless mini-incisionA flapless mini incision is used to place the dental implants |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients with adequate bone height and width at the site of implant 120 placement, and good quality bone to support a primary stability of at least 30 Ncm and D2 bone quality according to Lekholm and Zarb classification), based on preoperative radiographic assessment
- Clinical evidence of optimal periodontal health with no active periodontal disease in adjacent teeth
- No history of systemic illnesses that could affect bone health and wound heal- ing (e.g. uncontrolled diabetes mellitus, osteoporosis, renal osteodystrophy…etc.)
- No history of or requirement for bone grafting and augmentation at the implant site
- Willingness to participate in the study and attend prescribed follow-up appointments
Key exclusion criteria (5 listed)
- Patients with history of radiation therapy for head and neck cancer
- Patients with history of allergy and hypersensitivity to local anesthetic agents, and biomaterials used in dental implants
- Pregnant women and lactating mothers
- History of smoking (>2 cigarettes per day)
- Patients under treatment with anti-resorptive or anti-neoplastic medication such as bisphosphonates, chemotherapeutic agents, and monoclonal antibodies (e.g. Denosumab
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 |
|---|---|---|
| Flapless punchuse of flapless puch surgery to place dental implants | Procedure or surgery | Flapless punch |
| Flapless mini-incisionUse of a flapless mini-incision to place a dental implant | Procedure or surgery | Flapless mini-incision |
| Conventional flapUse of a conventional surgical flap to place a dental implant | Procedure or surgery | Conventional flap |
Primary outcome
Pain score
Time frame: 18 months postoperatively
Assessment of patient's pain level using Visual Analog Scale (VAS) which would be compared between groups. VAS is a visual scale 0 to 10 with 10 the highest pain score and 0 the lowest, the patient is asked to identify the pain level at the different timestops for comparison between groups
2 secondary outcomes
Soft-tissue healing
Time frame: 18 months postoperatively
Radiographic bone level
Time frame: 18 months postoperatively
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 15 Sep 2026.
- Individual participant dataSharing planned: Undecided. We might be sharing our data when needed according to the case
Related trials for IMPLANTATION
Not yet recruitingPhase 1/2
Effect of Povidone Iodine on the Dental Implant Internal Surface Microbiome
Dental Implant
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
Recruiting
Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty
Osteoporosis, Arthroplasty Complications
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 Phase 2 study testing Flapless punch, Flapless mini-incision and Conventional flap in people with IMPLANTATION and Dental Implant, run by Alaa Emara at 1 site in Saudi Arabia.
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 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 15 Sep 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 Saudi Arabia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain score (time frame: 18 months postoperatively). 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 15 Sep 2026.