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NCT Number: NCT07654452

Flap Vs 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.

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Key information

Conditions

Dental Implant Maxillary Tooth Loss Mouth Diseases Partial Edentulism Periodontal Diseases Stomatognathic Diseases Tooth Diseases Tooth Loss

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University, Faculty of Dentistry

Ismailia, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flap Implant Placement

Procedure

Implant placement following crestal incision and mucoperiosteal flap elevation to expose the alveolar ridge.

Flapless Implant Placement

Procedure

Implant placement performed without flap elevation using a minimally invasive flapless approach.

Primary outcomes

  1. Implant Stability Quotient (ISQ)

    Time frame: Immediately after implant placement and 6 months postoperatively.

    Implant stability measured using the Osstell resonance frequency analysis device.

  2. 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.

  3. 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.

Secondary outcomes

  1. Postoperative Pain

    Time frame: 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).

  2. Postoperative Edema

    Time frame: 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).

  3. Surgical Insertion Time

    Time frame: During surgery.

    Duration of implant placement surgery measured using a stopwatch.

  4. Postoperative Comfort

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

Assessment of Flap Versus Flapless Technique for Delayed Implant Placement in The Maxillary Esthetic Zone

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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