Qualitative and Quantitative Assessment of Marginal Bone Loss Following Flapless Guided Versus Conventional Implant Placement

NCT07663045 | Active Not Recruiting

• 1 other identifier: AbdallahMDSperio
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Marginal bone preservation is an important determinant of long-term implant success. Conventional flap implant placement provides direct visualization of the surgical site but may disturb the periosteal blood supply and contribute to early crestal bone remodeling. Flapless guided implant placement is a minimally invasive approach that aims to preserve soft tissue architecture and vascular integrity. CBCT allows three-dimensional evaluation of peri implant bone levels, including mesial, distal, buccal, and lingual aspects. Aim: The aim of this study was to compare flapless guided implant placement with conventional flap implant placement in terms of marginal bone loss, implant stability, postoperative pain, and soft-tissue healing.

Conditions

Guided Implant Placement; Delayed Implant; CBCT Segmentation

Keywords

CBCT

Outcome Measures

Primary Outcomes (1)

• Marginal Bone Loss

  CBCT assessment

  baseline, 3 months, 6 months

Secondary Outcomes (2)

• Implant Stability ISQ

  baseline, 3 months, 6 months

• Postoperative Pain Assessment VAS scale 0-10

  baseline, Day 2 Day 3 Day 4 Day 5

Study Arms (2)

Flapless Guided Implant Placement

EXPERIMENTAL

Procedure: Flapless guided implant

Conventional Flap Implant Placement

EXPERIMENTAL

Procedure: Conventional Flap Implant Placement

Interventions

Conventional Flap Implant Placement PROCEDURE

manually raising the gingival tissue during dental implant surgery, this surgical procedure involves the placement of a dental implant directly into the alveolar or basal bone during a single session followed by the placement of a healing abutment without the use of surgical guides or advanced technology.

Conventional Flap Implant Placement

Flapless guided implant PROCEDURE

a minimally invasive dental implant procedure where a surgical guide, often created using advanced imaging techniques like cone-beam computed tomography (CBCT) and computer-aided design (CAD), directs the precise placement of dental implants without the need for traditional flap elevation.

Flapless Guided Implant Placement

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 20 years or older.
• Patients requiring at least two dental implants within the same arch.
• Patients with good general health and able to undergo oral surgery.
• Patients willing to participate in the study and provide informed consent.
• Patients with adequate bone volume for implant placement as determined by preoperative radiographic assessment (e.g., cone beam computed tomography).

You may not qualify if:

• Patients with systemic diseases that could compromise healing or implant success (e.g., uncontrolled diabetes, immunocompromised conditions).
• Patients with a history of radiation therapy to the head and neck region.
• Patients with active periodontal disease or untreated oral infections.
• Patients who are pregnant or breastfeeding.
• Patients with a history of bisphosphonate therapy or other medications that may affect bone metabolism.
• Smoker Patients with a history of smoking or heavy alcohol consumption.
• Patients with unrealistic expectations or inability to comply with postoperative care instructions.
• Patients with significant facial trauma or anatomical deformities affecting the implant site.
• Patient who requires Immediate implant placement
• Thin gingival biotype

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (1)

Gulf Medical University

Ajman, Ajman Emirate, 00000, United Arab Emirates

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split mouth design

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: July 1, 2025
• Primary Completion: July 1, 2026
• Study Completion: July 30, 2026
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

AE (1)