Osseodensification Versus Alveolar Ridge Splitting

NCT06728202 | Not Yet Recruiting

• 1 other identifier: Horizontal Ridge Augmentation
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluation of clinical and radiological outcomes of the alveolar ridge splitting technique versus Osseodensification burs in atrophic maxillary alveolar ridges in horizontal dimension.

Conditions

Maxillary Deficiency; Horizontal Alveolar Bone Defect

Keywords

Osseodensification; Alveolar Ridge Splitting; Dental implant

Outcome Measures

Primary Outcomes (1)

• Gained bone width :

  will be measured immediately after surgery by CBCT using the following reference points: 1. Ridge width (RW): the distance between the buccal and palatal border of the bone at the crest. 2. Buccal bone thickness (BBT): the distance from the implant surface to the outer margin of bone. All variables will be measured twice with an interval of 1 week between measurements.

  preoperative , immediate postoperative and 6 months postoperative.

Secondary Outcomes (2)

• Bone density :

  Immediate post operative and 6 months postoperative

• primary stability:

  immediately and 6 months post-operative

Study Arms (2)

Alveolar ridge split group:

ACTIVE COMPARATOR

* a crestal incision and two vertical releasing incisions will be formed, followed by a full-thickness mucoperiosteal flap. * the flap will be raised to expose the whole length facial cortical bone. * The palatal mucoperiosteum will also be slightly reflected for better exposure of the crest of the alveolar ridge and free placement of the surgical guides. * the patient specific guides will be placed and fixed by monocortical osteosynthesis screws at the pre-planned positions at the labial cortical plate of bone , precisely locate the mid-crestal and two vertical stop cuts to improve the accuracy of the procedure, preventing bad splits with the aim of reducing the final marginal bone loss associated with this technique. * bony cut will be performed using a piezoelectric device on the facial aspect of alveolar ridge 1.5 mm away from the adjacent teeth or implants, extending 7 mm apically from the crest of the ridge.implants will be inserted in the osteotomy sites using torque-wrench

Procedure: A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge

Implant placement in pristine bone with Osseodensification burs group:

ACTIVE COMPARATOR

* A crestal incision and two vertical releasing incisions will be formed, followed by a full-thickness mucoperiosteal flap * Implant osteotomies are being performed with the assistance of saline irrigation. The osteotomies will be performed at 800-1500 rpm in a counterclockwise direction (Densifying Mode) with the use of sequential burs of similar diameter (OD drilling burs) used with copious irrigation in a Bouncing-Pumping motion (minor vertical pressure to advance the drill into the osteotomy, then pull out for pressure relief, then advance with vertical pressure again and so on in an in/out fashion). the instrumentation will be performed according to the recommended drilling protocols for Densah® Burs implant system; either by standard drilling, as recommended by implant company protocols. * The insertion of the implants will be initiated with the motor handpiece, without irrigation at 20-50 rpm, and installation will be completed with a manual surgical torque wrench

Procedure: A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge

Interventions

A Horizontal Ridge Augmentation in Atrophic Maxillary Ridge PROCEDURE

Aiming to enhance bone volume (Quantity) in horizontal maxillary bone defects and density (Quality) , providing a viable solution for implant stability and long-term success.

Alveolar ridge split group:; Implant placement in pristine bone with Osseodensification burs group:

Eligibility Criteria

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

You may qualify if:

• I. Patients with atrophic maxillary alveolar ridges in horizontal dimension \<18 years old. II. the bucco-palatal alveolar ridge dimension 2-4 mm III. a minimal vertical bone height of 10 mm

You may not qualify if:

• I. Bad oral hygiene. II. Patients with non healthy habits as (Smokers, Alcoholics, or drug abusers). III. Patients with any active periapical pathosis. IV. Patients treated with chemo or radiotherapy during the past 5 years. V. Acute and progressive periodontal disease. VI. Medically compromised patient not indicated for surgical procedures. VII. Patient with history of bleeding disorders. VIII. Patient with osteo-porotic disease.

Sponsors & Collaborators

• Fayoum University: lead

MeSH Terms

Conditions

Retrognathia

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Islam Wesam Saied Sayed

CONTACT

+201006657280; iw1130@fayoum.edu.eg

Mohammed Bahaa Khedr, Professor

CONTACT

+201061159076

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Administrative Dentist at Oral and Maxillofacial surgery department - Faculty of Dentistry at Fayoum University

Model Details: This is a prospective randomized (1:1) clinical trial study formed of 2 competitive groups where 46 implants will be placed in 2 groups (23 for each group) to compare the Gained bone width in patients with atrophic maxillae (Horizontal defect) .

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12