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

M

Mansoura University

Status

Completed

Conditions

Alveolar Ridge Augmentation

Treatments

Procedure: Modified Ridge-Splitting

Study type

Interventional

Funder types

Other

Identifiers

NCT06200077
A01051021

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

25 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

18 participants in 3 patient groups

Conventional Ridge-Splitting Group
Sham Comparator group
Description:
Six 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.
Treatment:
Procedure: Modified Ridge-Splitting
Modified 3-Staged Ridge-Splitting Group
Active Comparator group
Description:
Six 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.
Treatment:
Procedure: Modified Ridge-Splitting
Modified 2-Staged Ridge-Splitting Group
Experimental group
Description:
Six 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.
Treatment:
Procedure: Modified Ridge-Splitting

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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