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

Qualitative and Quantitative Assessment of Marginal Bone Loss Following Flapless Guided Versus Conventional Implant Placement Using Cone Beam Computed Tomography - A Split-Mouth Randomized Controlled Trial.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: CBCT Segmentation; Delayed Implant; Guided Implant Placement
• Intervention / Treatment: Procedure: Flapless guided implant; Procedure: Conventional Flap Implant Placement

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Arab Emirates
  • Ajman Emirate
    • Ajman, Ajman Emirate, United Arab Emirates, 00000
      • Gulf Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flapless Guided Implant Placement	Procedure: Flapless guided implant; 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.
Experimental: Conventional Flap Implant Placement	Procedure: Conventional Flap Implant Placement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Bone Loss	CBCT assessment	baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Stability ISQ	Implant stability was assessed as a secondary outcome using Resonance Frequency Analysis (RFA), which provides an objective and non-invasive measurement of implant stability expressed as the Implant Stability Quotient (ISQ).	baseline, 3 months, 6 months
Postoperative Pain Assessment VAS scale 0-10	VAS scale 0-10	baseline, Day 2 Day 3 Day 4 Day 5

Collaborators and Investigators

• Sponsor: Gulf Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: CBCT
• Other Study ID Numbers: AbdallahMDSperio

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No