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OpenTrials
Completed

NCT Number: NCT07008079

Flapless Mini-incision Implant Surgery

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

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Key information

Conditions

Implantation Dental Implant Dental Implant Placement Peri-Implant Tissues

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

King Saud University

Riyadh, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Flapless punch

Procedure

use of flapless puch surgery to place dental implants

Flapless mini-incision

Procedure

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

conventional flap

Procedure

Use of a conventional surgical flap to place a dental implant

Primary outcomes

  1. Pain score

    Time frame: 18 months postoperatively

    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

Secondary outcomes

  1. Soft-tissue healing

    Time frame: 18 months postoperatively

    Assess the healing of overlaying soft tissue. Check for signs of infection , swelling, dehiscnce or inflammation

  2. Radiographic bone level

    Time frame: 18 months postoperatively

    Assessment of bone level postoperatively. A CBCT is ordered to assess bone density in hounsfeld unitsto assess level of bone maturation. This would then be compared across groups and between different time points to show bone deposition and healing.

Sponsors and collaborators

Lead sponsor

Alaa Emara

Other

Collaborators

  • King Saud University

Registry information

Official study title

Flapless Mini-incision Implant Surgery vs Conventional Flap or Flapless Implant Surgery: A Prospective, Randomized, Single Blind, Clinical and Radiographic Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2025
Registry last updated
Jun 6, 2025

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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