Dental Implant, Maxillary Tooth Loss, Partial Edentulism, Tooth Loss
Conditions
Keywords
Dental Implant, Flapless Implant Surgery, Flap Technique, Dental Implant Stability, Marginal Bone Loss
Brief 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. 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.
Interventions
PROCEDUREFlap Implant Placement
Implant placement following crestal incision and mucoperiosteal flap elevation to expose the alveolar ridge.
PROCEDUREFlapless Implant Placement
Implant placement performed without flap elevation using a minimally invasive flapless approach.
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Stability Quotient (ISQ) | Immediately after implant placement and 6 months postoperatively. | Implant stability measured using the Osstell resonance frequency analysis device. |
| Marginal Crestal Bone Loss | 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 | Immediately postoperative, 1 month, 3 months, and 6 months. | Radiographic assessment of peri-implant bone density using standardized digital periapical radiographs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | Postoperative days 1, 3, and 7. | 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 Edema | Postoperative days 1,3 and 7. | 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). |
| Surgical Insertion Time | During surgery. | Duration of implant placement surgery measured using a stopwatch. |
| Postoperative Comfort | 1 day postoperatively | 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). |
Countries
Egypt
Contacts
STUDY_CHAIRMohamed Said Hamed, Professor of Oral and Maxillof
Suez Canal University
STUDY_DIRECTORAhmed Abdelmohsen Younis, Associate Professor of Oral an
Suez Canal University
PRINCIPAL_INVESTIGATORMina Raafat, B.S.D
Suez Canal University
Outcome results
None listed