Evaluation of Marginal Bone Loss Using Computer Guided Ridge Splitting Technique With Simultaneous Implant Placement.

NCT03989193 | Unknown DMC

• 1 other identifier: guidedsplit surgerymsc
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical report describes a technique for ridge splitting, and gradual expansion in the maxilla with simultaneous implant placement with in the split ridge, with the preservation of the thin buccal plate of bone for proper blood supply.

Conditions

Marginal Bone Loss; Computer Guided; Ridge Splitting

Outcome Measures

Primary Outcomes (1)

• the amount of marginal bone loss

  the amount of marginal bone loss of thin narrow ridge after 6 months of splitting bone taking the implant as guide measured in mm determined on cone beam CT (panoramic and cross-sectional views).

  6 months

Study Arms (1)

Computer guided alveolar ridge splitting technique

EXPERIMENTAL

Computer guided alveolar ridge splitting using piezo electric device and a 3D printed surgical guide. An L shaped splitting pattern with one crestal and one distal cut will be performed.

Device: Computer guided alveolar ridge splitting technique

Interventions

Computer guided alveolar ridge splitting technique DEVICE

The bone splitting technique could be performed using the piezoelectric system, calibrating the device on D1 setting and using profuse saline irrigation. The preparation sequence begins with CS3 insert until a total depth of 10mm was achieved across the entire extension of the ridge. The procedure continued with the CS1 insert and finally the CS2 insert. The vertical bone cuts through the cortical layer: At the distal end of the horizontal split, a vertical cut will made with the high-speed bur within the vicinity of the buccal plate to start the separation, with a full vertical depth of 13 mm. Final design of the splitting cut was L-shaped split. At the distal and the mesial end of the horizontal split, a vertical cut was made with the high-speed bur for a full vertical depth of 13mm.

Computer guided alveolar ridge splitting technique

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with thin maxillary ridge of 3 to 5 mm thickness of crestal alveolar bone (horizontal deficiency).
• Patients with free medical history and adequate proper oral hygiene.
• Patients of adequate alveolar bone height.
• Both genders males and females will be included.

You may not qualify if:

• General contraindications to implant surgery.
• Subjected to irradiation in the head and neck area less than 1 year before implantation.
• Untreated periodontitis.
• Poor oral hygiene and motivation.
• Uncontrolled diabetes.
• Pregnant or nursing.
• Substance abuse.
• Psychiatric problems or unrealistic expectations.
• Severe bruxism or clenching.
• Immunosuppressed or immunocompromised.
• Treated or under treatment with intravenous amino-bisphosphonates.
• Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
• Active infection or severe inflammation in the area intended for implant placement.
• Need of bone augmentation procedures at implant placement.
• Unable to open mouth sufficiently to accommodate the surgical tooling.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Basel Omer, MSc

CONTACT

+201091181748; baselhamzah@dentistry.cu.edu.eg

Ragia Mounir, PhD

CONTACT

+2010066993

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 9, 2019
• First Posted: June 18, 2019
• Study Start: November 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: July 31, 2020
• Last Updated: October 22, 2019

Record last verified: 2019-10