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Completed

NCT Number: NCT06200077

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

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.

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Key information

Conditions

Alveolar Ridge Augmentation

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlyia, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modified Ridge-Splitting

Procedure

Unlike the conventional ridge-splitting where bone grafting is done in the same visit after ridge splitting, modified ridge splitting involves splitting the ridge only at the first visit, then bone grafting is done either alone afterwards in the second visit (Modified 3-Staged Ridge-Splitting Group) and dental implants will be placed in the third visit, or, as in the Modified 2-Staged Ridge-Splitting Group, bone grafting and dental implants placement will be done in the second visit.

Primary outcomes

  1. Alveolar ridge width

    Time frame: immediately 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 outcomes

  1. Implant stability

    Time frame: immediately 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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Clinical Outcomes of Different Staged Ridge-Splitting Techniques Using Piezo-Electric Surgery in Atrophic Posterior Mandible

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2024
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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