Dental ImplantNCT07654452
Flap Vs Flapless Technique for Delayed Implant Placement in the Maxillary Esthetic Zone
A study testing Flap Implant Placement and Flapless Implant Placement in people with Dental Implant and Tooth Loss, run by Suez Canal University at 1 site in Egypt.
Trial summary
This randomized comparative clinical trial aims to evaluate the clinical, radiographic, and esthetic outcomes of flap versus flapless techniques for delayed dental implant placement in the maxillary esthetic zone. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Tooth Loss, Partial Edentulism
- What is being tested?
- Flap Implant Placement and Flapless Implant Placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2025to 10 May 2026
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged from 30 to 50 years old.
- Adults of both genders.
- Patients who are free from any systemic disease (ASA I).
- Patients with teeth loss at upper anterior and premolar regions more than 1-year.
- Presence of sufficient apical and peripheral bone to achieve primary implant stability (minimum 3-5 mm of bone beyond the socket apex and overall socket length ≥ 10 mm).
- Patients with bone quality classified as D3, as assessed by pre-operative CBCT.
Who cannot join
- Pregnant and lactating women.
- Heavy smoking (>10 cigarettes/day)
- Patients with bad oral habits such as bruxism.
- Patients with poor oral hygiene.
- Patients with gingival diseases.
- Patients with periodontal diseases (with severe vertical or horizontal bone loss).
- Teeth with periapical or lateral infection or lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Flap Versus Flapless Technique for Delayed Implant Placement in The Maxillary Esthetic Zone
This randomized comparative clinical trial aims to evaluate the clinical, radiographic, and esthetic outcomes of flap versus flapless techniques for delayed dental implant placement in the maxillary esthetic zone. Twenty patients requiring implant placement in the maxillary anterior or premolar region will be randomly allocated into two equal groups. Group I will undergo implant placement using the conventional flap technique, while Group II will receive implant placement using the flapless technique. Clinical outcomes including postoperative pain, edema, surgical insertion time, and implant stability will be assessed. Radiographic evaluation will include peri-implant bone quantity, bone quality, and crestal bone loss. Follow-up examinations will be performed immediately after surgery and at 1, 3 and 6 months postoperatively.
- Conditions
- Dental Implant, Tooth Loss, Partial Edentulism, Maxillary Tooth Loss
- Being tested
- Flap Implant Placement, Flapless Implant Placement
- Keywords
- Dental Implant, Flapless Implant Surgery, Flap Technique, Dental Implant Stability, Marginal Bone Loss
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flap Implant PlacementProcedure or surgery
Implant placement following crestal incision and mucoperiosteal flap elevation to expose the alveolar ridge.
Flapless Implant PlacementProcedure or surgery
Implant placement performed without flap elevation using a minimally invasive flapless approach.
| Study group | Role | What they receive |
|---|---|---|
| Flap Technique | Experimental | Delayed implant placement using a conventional full-thickness mucoperiosteal flap approach. Receives: Procedure: Flap Implant Placement |
| Flapless Technique | Experimental | Delayed implant placement using a flapless surgical approach. Receives: Procedure: Flapless Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Stability Quotient (ISQ)
Implant stability measured using the Osstell resonance frequency analysis device.
Measured: Immediately after implant placement and 6 months postoperatively.
Marginal Crestal Bone Loss
Radiographic assessment of peri-implant crestal bone level changes using standardized digital periapical radiographs.
Measured: Immediately postoperative, 1 month, 3 months, and 6 months.
Relative bone density
Radiographic assessment of peri-implant bone density using standardized digital periapical radiographs.
Measured: Immediately postoperative, 1 month, 3 months, and 6 months.
Secondary outcomes (4)
Postoperative Pain
Postoperative pain intensity measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate greater pain severity (worse outcome).
Measured: Postoperative days 1, 3, and 7.
Postoperative Edema
ostoperative facial swelling assessed using a 4-grade Visual Edema Scale, with scores ranging from 1 to 4, where 1 = no edema, 2 = mild edema, 3 = moderate edema, and 4 = severe edema. Higher scores indicate greater postoperative facial swelling (worse outcome).
Measured: Postoperative days 1,3 and 7.
Surgical Insertion Time
Duration of implant placement surgery measured using a stopwatch.
Measured: During surgery.
Postoperative Comfort
Patient-reported postoperative comfort assessed using a 5-point Likert Scale Questionnaire, with scores ranging from 1 to 5, where 1 = very uncomfortable and 5 = very comfortable. Higher scores indicate greater postoperative comfort (better outcome).
Measured: 1 day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start10 Jan 2025
- Primary completion10 Apr 2026
- Study completion10 May 2026
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned into two parallel groups. One group will receive delayed implant placement using the conventional flap technique, while the second group will receive delayed implant placement using the flapless technique.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina raafat, Suez Canal University
- Investigators
- Mohamed Said Hamed, Professor of Oral and Maxillof, Study chair, Suez Canal UniversityAhmed Abdelmohsen Younis, Associate Professor of Oral an, Study director, Suez Canal UniversityMina Raafat, B.S.D, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654452
- Sponsor's protocol ID
- 970/2025
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Flap Versus Flapless Technique for Delayed Implant Placement in The Maxillary Esthetic Zone
- ClinicalTrials.gov ID
- NCT07654452
- Acronym / sponsor ID
- 970/2025
- Conditions
- Dental Implant, Tooth Loss, Partial Edentulism, Maxillary Tooth Loss
- Keywords
- Dental Implant, Flapless Implant Surgery, Flap Technique, Dental Implant Stability, Marginal Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 May 2026 (actual)
- First posted
- 17 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.
This randomized comparative clinical trial aims to evaluate the clinical, radiographic, and esthetic outcomes of flap versus flapless techniques for delayed dental implant placement in the maxillary esthetic zone. Twenty patients requiring implant placement in the maxillary anterior or premolar region will be randomly allocated into two equal groups. Group I will undergo implant placement using the conventional flap technique, while Group II will receive implant placement using the flapless technique. Clinical outcomes including postoperative pain, edema, surgical insertion time, and implant stability will be assessed. Radiographic evaluation will include peri-implant bone quantity, bone quality, and crestal bone loss. Follow-up examinations will be performed immediately after surgery and at 1, 3 and 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into two parallel groups. One group will receive delayed implant placement using the conventional flap technique, while the second group will receive delayed implant placement using the flapless technique.
| Arm | Type | Receives |
|---|---|---|
| Flap Technique | Experimental | Procedure: Flap Implant PlacementDelayed implant placement using a conventional full-thickness mucoperiosteal flap approach. |
| Flapless Technique | Experimental | Procedure: Flapless Implant PlacementDelayed implant placement using a flapless surgical approach. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients aged from 30 to 50 years old.
- Adults of both genders.
- Patients who are free from any systemic disease (ASA I).
- Patients with teeth loss at upper anterior and premolar regions more than 1-year.
- Presence of sufficient apical and peripheral bone to achieve primary implant stability (minimum 3-5 mm of bone beyond the socket apex and overall socket length ≥ 10 mm).
Key exclusion criteria (7 listed)
- Pregnant and lactating women.
- Heavy smoking (>10 cigarettes/day)
- Patients with bad oral habits such as bruxism.
- Patients with poor oral hygiene.
- Patients with gingival diseases.
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 |
|---|---|---|
| Flap Implant PlacementImplant placement following crestal incision and mucoperiosteal flap elevation to expose the alveolar ridge. | Procedure or surgery | Flap Technique |
| Flapless Implant PlacementImplant placement performed without flap elevation using a minimally invasive flapless approach. | Procedure or surgery | Flapless Technique |
Primary outcome
Implant Stability Quotient (ISQ)
Time frame: Immediately after implant placement and 6 months postoperatively.
Implant stability measured using the Osstell resonance frequency analysis device.
Marginal Crestal Bone Loss
Time frame: Immediately postoperative, 1 month, 3 months, and 6 months.
Radiographic assessment of peri-implant crestal bone level changes using standardized digital periapical radiographs.
Relative bone density
Time frame: Immediately postoperative, 1 month, 3 months, and 6 months.
Radiographic assessment of peri-implant bone density using standardized digital periapical radiographs.
4 secondary outcomes
Postoperative Pain
Time frame: Postoperative days 1, 3, and 7.
Postoperative Edema
Time frame: Postoperative days 1,3 and 7.
Surgical Insertion Time
Time frame: During surgery.
Postoperative Comfort
Time frame: 1 day 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 7 Jul 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.
Mohamed Said Hamed, Professor of Oral and Maxillof study chair
Suez Canal University
Ahmed Abdelmohsen Younis, Associate Professor of Oral an study director
Suez Canal University
Mina Raafat, B.S.D principal investigator
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flap Implant Placement and Flapless Implant Placement in people with Dental Implant and Tooth Loss, run by Suez Canal 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 6 inclusion and 7 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 7 Jul 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 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?
Implant Stability Quotient (ISQ) (time frame: Immediately after implant placement and 6 months postoperatively.). The study lists 3 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 7 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.