Flap Vs Flapless Technique for Delayed Implant Placement in the Maxillary Esthetic Zone

Suez Canal University20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dental Implant Tooth Loss Partial Edentulism Maxillary Tooth Loss

Eligibility

Sex: ALLMin age: 30 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Implant Stability Quotient (ISQ)

Implant stability measured using the Osstell resonance frequency analysis device.

Time frame: 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.

Time frame: Immediately postoperative, 1 month, 3 months, and 6 months.

Relative bone density

Radiographic assessment of peri-implant bone density using standardized digital periapical radiographs.

Time frame: Immediately postoperative, 1 month, 3 months, and 6 months.

Secondary Outcomes

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).

Time frame: 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).

Time frame: Postoperative days 1,3 and 7.

Surgical Insertion Time

Duration of implant placement surgery measured using a stopwatch.

Time frame: 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).

Time frame: 1 day postoperatively