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

Alveolar Ridge Augmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06200077
• Other study ID #: A01051021
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Ridge Augmentation
• Atrophy

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Mansoura University	Mansoura	Dakahlyia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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