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Patient Outcomes of Staged Ridge-splitting Using Piezo-electric Surgery in Atrophic Posterior Mandible

Not Applicable
Completed
Conditions
Alveolar Ridge Augmentation
Interventions
Procedure: Modified Ridge-Splitting
Registration Number
NCT06200077
Lead Sponsor
Mansoura University
Brief Summary

This study aims to evaluate the clinical and radiographic outcomes of different staged ridge-splitting techniques for management of severely resorbed lower jaws in the posterior region. The study is designed as a clinical trial, so that three different interventions would be compared for a conclusion highlighting the relative best of them.

Detailed Description

In the context of the care of severely resorbed lower jaws in the posterior region, the purpose of this study is to evaluate the clinical and radiographic outcomes of several stepwise ridge-splitting procedures. The study is supposed to be a clinical trial, with the purpose of comparing three distinct therapies in order to get a result that highlights which of them is the most effective in comparison to the others.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
18
Inclusion Criteria
  • Patients were free from any relevant systemic diseases according to American society of Anesthesiologists classifications.
  • Patients of single or multiple missing teeth in the posterior mandible.
  • A ridge width of minimum 4mm and a 10 mm ridge height with 2mm minimum above Inferior Alveolar Nerve (IAN) were present in CBCT images.
  • Absence of buccal concavities at the planned implant site.
Exclusion Criteria
  • History of any systemic diseases or medication that alters bone metabolism.
  • Poor oral hygiene.
  • Heavy smoker (more than 20 cigarettes/day) or alcoholic patients.
  • Chemotherapy or radiation therapy to the head and neck region in the last 12 months prior to the proposed implant therapy.
  • Patients currently on or with a history of bisphosphonate therapy.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Conventional Ridge-Splitting GroupModified Ridge-SplittingSix dental implant sites were prepared in three patients initially through ridge splitting technique associated with bone grafting followed by implants insertion after 4 months later.
Modified 2-Staged Ridge-Splitting GroupModified Ridge-SplittingSix dental implant sites were prepared in three patients initially through mucogingival, and bony incision followed by ridge splitting technique, bone grafting and implants insertion at the same time after 4 weeks from the bony incision.
Modified 3-Staged Ridge-Splitting GroupModified Ridge-SplittingSix dental implant sites were prepared in four patients through mucogingival and bony incision initially then after 3-4 weeks ridge splitting with bone grafting were done, followed by implants insertion after 4 months later.
Primary Outcome Measures
NameTimeMethod
Alveolar ridge widthimmediately after implant placement, immediately after implant loading and six months after implant loading

Radiographically via Cone-beam Computed Tomography (CBCT), the width of the alveolar bone was measured horizontally from the buccal to lingual cortex below the crest of the alveolar bone from 3 levels at 1 mm, 3 mm and 6 mm on three cross-sections by the CBCT software (OnDemand, Cybermed Inc, Korea).

Secondary Outcome Measures
NameTimeMethod
Implant stabilityimmediately after implant placement, immediately after implant loading and six months after implant loading

Smartpeg was installed in the dental implant fixture. From both buccal and lingual directions, an analyzer probe was located closer to the Smartpeg, and the implant stability quotient (ISQ) values were obtained from the Osstell Monitor

Trial Locations

Locations (1)

Faculty of Dentistry, Mansoura University

🇪🇬

Mansoura, Dakahlyia, Egypt

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