NCT06200077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

January 10, 2024

Status Verified

November 1, 2021

Enrollment Period

1.5 years

First QC Date

December 28, 2023

Last Update Submit

December 28, 2023

Conditions

Alveolar Ridge Augmentation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Implant stability

    immediately after implant placement, immediately after implant loading and six months after implant loading

Study Arms (3)

Conventional Ridge-Splitting Group

SHAM COMPARATOR

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

Modified 3-Staged Ridge-Splitting Group

ACTIVE COMPARATOR

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

Modified 2-Staged Ridge-Splitting Group

EXPERIMENTAL

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

Interventions

Modified Ridge-SplittingPROCEDURE

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.

Conventional Ridge-Splitting GroupModified 2-Staged Ridge-Splitting GroupModified 3-Staged Ridge-Splitting Group

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlyia, 35511, Egypt

Location

Related 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.

    PMID: 29534117BACKGROUND

Study Officials

  • Mena Tamer, MSc

    Faculty of Dentistry, Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 10, 2024

Study Start

December 1, 2021

Primary Completion

June 1, 2023

Study Completion

October 1, 2023

Last Updated

January 10, 2024

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)