Flapless Mini-incision Implant Surgery

NCT ID: NCT07008079

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-03-31

Brief Summary

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

Detailed Description

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Conditions

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IMPLANTATION Dental Implant Dental Implant Placement Peri-Implant Tissues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional flap

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

Group Type ACTIVE_COMPARATOR

Conventional flap

Intervention Type PROCEDURE

Use of a conventional surgical flap to place a dental implant

Flapless punch

A flapless punch is used to place the dental implants

Group Type EXPERIMENTAL

Flapless punch

Intervention Type PROCEDURE

use of flapless puch surgery to place dental implants

Flapless mini-incision

A flapless mini incision is used to place the dental implants

Group Type EXPERIMENTAL

Flapless mini-incision

Intervention Type PROCEDURE

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

Interventions

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Flapless punch

use of flapless puch surgery to place dental implants

Intervention Type PROCEDURE

Flapless mini-incision

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

Intervention Type PROCEDURE

Conventional flap

Use of a conventional surgical flap to place a dental implant

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Saud University

OTHER

Sponsor Role collaborator

Alaa Emara

OTHER

Sponsor Role lead

Responsible Party

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Alaa Emara

A.Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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King Saud University

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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Flapless mini-incision implant

Identifier Type: -

Identifier Source: org_study_id

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