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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flap Technique | Experimental | Delayed implant placement using a conventional full-thickness mucoperiosteal flap approach. |
|
| Flapless Technique | Experimental | Delayed implant placement using a flapless surgical approach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flap Implant Placement | Procedure | Implant placement following crestal incision and mucoperiosteal flap elevation to expose the alveolar ridge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant Stability Quotient (ISQ) | Implant stability measured using the Osstell resonance frequency analysis device. | 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. | Immediately postoperative, 1 month, 3 months, and 6 months. |
| Relative bone density | Radiographic assessment of peri-implant bone density using standardized digital periapical radiographs. | Immediately postoperative, 1 month, 3 months, and 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Postoperative days 1, 3, and 7. |
| Postoperative Edema |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Said Hamed, Professor of Oral and Maxillof | Suez Canal University | Study Chair |
| Ahmed Abdelmohsen Younis, Associate Professor of Oral an | Suez Canal University | Study Director |
| Mina Raafat, B.S.D | Suez Canal University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suez Canal University, Faculty of Dentistry | Ismailia | Egypt |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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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.
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| Flapless Implant Placement | Procedure | Implant placement performed without flap elevation using a minimally invasive flapless approach. |
|
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). |
| Postoperative days 1,3 and 7. |
| Surgical Insertion Time | Duration of implant placement surgery measured using a stopwatch. | 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). | 1 day postoperatively |