Minimally Invasive Ridge Splitting Versus the Conventional Open Flap Technique

NCT06329362 | Recruiting DMC

• 1 other identifier: 2-7-23
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (2)

• Implant stability.

  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

  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 Outcomes (2)

• Postoperative Pain

  to be completed by day 7 postoperative, describing the pain felt.

• Operation Time

  Time of the procedure from the beginning to the end.

Study Arms (2)

Minimal Invasive Implant ridge splitting

ACTIVE COMPARATOR

Using minimally invasive implant placement in atrophied ridge without mucoperiosteal flap, and specially designed implant shaped expanders.

Procedure: Minimally invasive implantation

conventional open flap ridge splitting implantation.

ACTIVE COMPARATOR

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.

Interventions

Minimally invasive implantation PROCEDURE

Specially designed ridge splitting instrumentation by Champions Implant GmbH which is implant shaped expanders.

Also known as: Champions Implant GmbH

Minimal Invasive Implant ridge splitting

Open flap procedure for ridge expansion. PROCEDURE

Mucoperiosteal elevation and ridge splitting using conventional ridge expanders.

Also known as: Ridge splitting.

conventional open flap ridge splitting implantation.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient with Bone density D2 and D3.
• Good general systemic condition.
• Committed patient to attend follow up appointment.

You may not qualify if:

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

Sponsors & Collaborators

• The Royal College of Surgeons of Edinburgh: lead

Study Sites (2)

Faculty of Dentistry Cairo University

Cairo, 35855, Egypt

RECRUITING

Future Dental Academy GmbH

Flonheim, Rhineland-Palatinate, D-55237, Germany

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Emad Deif, Prof.

  Head of Oral and Maxillofacial Surgery Department - Faculty of Dentistry Cairo University

  STUDY CHAIR

Central Study Contacts

Bassem Hussein, MDs

CONTACT

+201001113474; bassem_26@hotmail.com

Emad Deif, Prof

CONTACT

+201222331938; daif_emad@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral and Maxillofacial Surgeon

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 25, 2024
• Study Start: July 31, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); EG (1)