Minimally Invasive Ridge Splitting Versus the Conventional Open Flap Technique

March 24, 2024 updated by: Bassem Emad AbdElMoneim, The Royal College of Surgeons of Edinburgh

Quantitative Assessment of Bone Comparing the Minimally Invasive Ridge Splitting Versus the Conventional Open Flap Technique

The goal of this clinical trial is to compare implant stability, and crestal bone loss, when using minimal invasive ridge splitting versus convenient open flap technique. The main question is Does Minimal Invasive Implant ridge splitting ("transmucosal" without flap) influence the implant stability and crystal bone loss, when compared with the conventional open flap techniques? Researchers will compare Group A: Minimal Invasive Implant ridge splitting and Group B: Triangular flap technique is used to see if there is significant difference between the two groups when measuring implant stability, and crestal bone density.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Diagnostic stage:

Explanation of the operative procedure and obtaining the participants consent. Comprehensive clinical examination and understanding of participants chief complains and needs will be carried out.

CBCT acquisition:

Cone Beam Computed Tomography (CBCT) scans for the participants will be Taken preoperatively to determine the following:

  1. Bone density (D1 & D4 for exclusion, while D2 & D3 shall be included)
  2. To confirm the ridge mapping indicating alveolar ridge class IV. (Where height is adequate > 10mm, while width is "3-4 mm").

Planning the surgical procedure:

All planned surgical procedure will be carried out by main candidate under supervision.

Implant are planned to be placed (2 implants are placed in each segment "30-40 mm")

Surgical procedure:

Scrubbing and draping of the participants will be carried out in a standard fashion.

Local anesthesia (lidocaine 2%o,1/100000 adrenaline) Group A: Minimal Invasive Implant ridge splitting. A horizontal incision is made using fine end bur with high-speed hand piece deep from the edge of the ridge, passing down the cortical plate to the depth of the spongy bone, without mucoperiosteal elevation.

Using specially designed implant like bone expanders (Champions implants GmbH) to widen ridge with sequential application (which are 2.4, 2.8, 3.0, 3.3,3.8,4.3, and 5.3 mm in Diameter).

With each step the investigators shall carefully check the bone integrity and depth using calibrated probe.

By reaching the desired depth and width (till size 3.3 condensers and place 3.5 x 8 mm implants as a standard, using torque gage adjusted at 30-40 Newton's, that's to avoid pressure that might lead to initial resorption.

Closure of the incision line using interrupted suturing.

Group B: Triangular flap technique is used. With the horizontal component on the ridge and the vertical component posteriorly to avoid injury to the mental nerve, allowed by mucoperiosteal elevation to expose the target area.

2 vertical cuts on both ends to facilitate the ridge expansion, without the risk of crack or fracture of the buccal segment using conventional chisels till reaching the desired width that would accommodate the same implant diameter as for group A.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  1. Patients with atrophic posterior mandibular ridge with edentulous area 30-40 mm, minimum width 3-4 mm, and adequate height indicated for implant placement >9 mm.
  2. Patient with Bone density D2 and D3.
  3. Good general systemic condition.
  4. Committed patient to attend follow up appointment.

Exclusion criteria:

  1. Patients with systemic diseases that may affect the healing process of hard or soft tissues (e.g., uncontrolled diabetes mellitus).
  2. Patient on medication that could hinder the normal healing process (e.g., steroids, immunosuppressant)
  3. Patients with intra-bony lesions or infections.
  4. Patient with bad habits (e.g. alcohol or Substance abuse).
  5. Patient who received head and neck radiotherapy or chemotherapy in the last 10 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Minimal Invasive Implant ridge splitting
Using minimally invasive implant placement in atrophied ridge without mucoperiosteal flap, and specially designed implant shaped expanders.
Procedure: Minimally invasive implantation
Specially designed ridge splitting instrumentation by Champions Implant GmbH which is implant shaped expanders.
Other Names:
  • Champions Implant GmbH
Active Comparator: conventional open flap ridge splitting implantation.
Using the conventional open flap technique with mucoperiosteal elevation to expose the ridge with the use of conventional bone expanders and chisels.
Procedure: Open flap procedure for ridge expansion.
Mucoperiosteal elevation and ridge splitting using conventional ridge expanders.
Other Names:
  • Ridge splitting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant stability.
Time Frame: immediate postoperative, 1, 2, and 3 months post operative.

Implant Stability Quotient (ISQ) evaluation via Ostell device for implant stability measurement, it measures on a scale from 1 to 100 and is a measure of the stability of an implant, less than 60 indicates low stability, 60-69 indicates medium stability, 70 and more indicates high stability.

Method of aggregation: Mean and standard deviation.

.
immediate postoperative, 1, 2, and 3 months post operative.
CBCT assessment
Time Frame: measurement points: preoperative, immediately postoperative, and 12 months postoperative, unless indicated otherwise e.g., Complications).
Bone density at the implant site in House field unit. A Hounsfield unit reading of 1250 and above indicates D1 bone. A Hounsfield reading between 850 to 1250 units is indicative of D2 bone. A Hounsfield reading between 350 and 850 units is indicative of type D3 bone. A Hounsfield reading between 150 and 350 units is indicative of D4 bone. Method of aggregation: Mean and standard deviation.
measurement points: preoperative, immediately postoperative, and 12 months postoperative, unless indicated otherwise e.g., Complications).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: to be completed by day 7 postoperative, describing the pain felt.

Specific measurement variable: Visual Analogue Scale (VAS Scale), scale chart to be completed by the patient from 0-10 where 0 means no pain and 10 means worst of pain.

Participant -level analysis: Final value. Method of aggregation: Mean and standard deviation
to be completed by day 7 postoperative, describing the pain felt.
Operation Time
Time Frame: Time of the procedure from the beginning to the end.

Specific measurement variable: operating time in minutes and seconds from the beginning to the end of the procedure.

Participant-level analysis: Final value. Method of aggregation: Mean and standard deviation.
Time of the procedure from the beginning to the end.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Royal College of Surgeons of Edinburgh

Investigators

  • Study Chair: Emad Deif, Prof., Head of Oral and Maxillofacial Surgery Department - Faculty of Dentistry Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2023

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 24, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-7-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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