Flapless Mini-incision Implant Surgery

NCT07008079 | Completed Phase 2

• 1 other identifier: Flapless mini-incision implant
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

flapless surgery; mini-incision surgery; peri-implant soft tissue; dental implant

Outcome Measures

Primary Outcomes (1)

• Pain score

  Assessment of patient's pain level using Visual Analog Scale (VAS) which would be compared between groups. VAS is a visual scale 0 to 10 with 10 the highest pain score and 0 the lowest, the patient is asked to identify the pain level at the different timestops for comparison between groups

  18 months postoperatively

Secondary Outcomes (2)

• Soft-tissue healing

  18 months postoperatively

• Radiographic bone level

  18 months postoperatively

Study Arms (3)

Conventional flap

ACTIVE COMPARATOR

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

Procedure: Conventional flap

Flapless punch

EXPERIMENTAL

A flapless punch is used to place the dental implants

Procedure: Flapless punch

Flapless mini-incision

EXPERIMENTAL

A flapless mini incision is used to place the dental implants

Procedure: Flapless mini-incision

Interventions

Flapless punch PROCEDURE

use of flapless puch surgery to place dental implants

Flapless punch

Flapless mini-incision PROCEDURE

Use of a flapless mini-incision to place a dental implant

Flapless mini-incision

Conventional flap PROCEDURE

Use of a conventional surgical flap to place a dental implant

Conventional flap

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alaa Emara: lead
• King Saud University: collaborator

Study Sites (1)

King Saud University

Riyadh, Saudi Arabia

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: A.Professor

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 6, 2025
• Study Start: October 1, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-05

Locations

SA (1)