Flapless Mini-incision Implant Surgery

Alaa Emara

Status and phase: Completed; Phase 2

Conditions: Peri-Implant Tissues; Dental Implant Placement; Dental Implant; IMPLANTATION

Treatments: Procedure: Flapless punch; Procedure: Flapless mini-incision; Procedure: Conventional flap

Study type: Interventional

Funder types: Other

Identifiers

NCT07008079

Flapless mini-incision implant

Details and patient eligibility

About

evaluate the clinical efficacy of the flapless mini-incision method compared to conventional flap and flapless punch methods

Enrollment: 45 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with adequate bone height and width at the site of implant 120 placement, and good quality bone to support a primary stability of at least 30 Ncm and D2 bone quality according to Lekholm and Zarb classification), based on preoperative radiographic assessment
• Clinical evidence of optimal periodontal health with no active periodontal disease in adjacent teeth
• No history of systemic illnesses that could affect bone health and wound heal- ing (e.g. uncontrolled diabetes mellitus, osteoporosis, renal osteodystrophy...etc.)
• No history of or requirement for bone grafting and augmentation at the implant site
• Willingness to participate in the study and attend prescribed follow-up appointments

Exclusion criteria

• Patients with history of radiation therapy for head and neck cancer
• Patients with history of allergy and hypersensitivity to local anesthetic agents, and biomaterials used in dental implants
• Pregnant women and lactating mothers
• History of smoking (>2 cigarettes per day)
• Patients under treatment with anti-resorptive or anti-neoplastic medication such as bisphosphonates, chemotherapeutic agents, and monoclonal antibodies (e.g. Denosumab

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Conventional flap

Active Comparator group

Description:

The Standard commonly used surgical flap is used to place the dental implant

Treatment:

Procedure: Conventional flap

Flapless punch

Experimental group

Description:

A flapless punch is used to place the dental implants

Treatment:

Procedure: Flapless punch

Flapless mini-incision

Experimental group

Description:

A flapless mini incision is used to place the dental implants

Treatment:

Procedure: Flapless mini-incision