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

Clinical Outcomes of Different Staged Ridge-Splitting Techniques 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.

Study Overview

• Status: Completed
• Conditions: Alveolar Ridge Augmentation
• Intervention / Treatment: Procedure: Modified Ridge-Splitting

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlyia
    • Mansoura, Dakahlyia, Egypt, 35511
      • Faculty of Dentistry, Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Conventional Ridge-Splitting Group; 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.	Procedure: Modified Ridge-Splitting; 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.
Active Comparator: Modified 3-Staged Ridge-Splitting Group; 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.	Procedure: Modified Ridge-Splitting; 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.
Experimental: Modified 2-Staged Ridge-Splitting Group; 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.	Procedure: Modified Ridge-Splitting; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alveolar ridge width	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).	immediately after implant placement, immediately after implant loading and six months after implant loading

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability	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	immediately after implant placement, immediately after implant loading and six months after implant loading

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Mena Tamer, MSc, Faculty of Dentistry, Mansoura University

Publications and helpful links

General Publications

• Hu GH, Froum SJ, Alodadi A, Nose F, Yu YP, Suzuki T, Cho SC. A Three-Stage Split-Crest Technique: Case Series of Horizontal Ridge Augmentation in the Atrophic Posterior Mandible. Int J Periodontics Restorative Dent. 2018 July/August;38(4):565-573. doi: 10.11607/prd.2907. Epub 2018 Mar 13.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: December 28, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: A01051021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No