NCT05685576

Brief Summary

Patients with long span, narrow edentulous ridge in the posterior mandible underwent piezotomed ridge splitting and osseodensification with simultaneous implant placement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

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

March 25, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

January 4, 2023

Last Update Submit

May 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The score of primary implant stability

    \- Primary stability of the implants is measured using: * insertion torque and * resonance frequency analysis by Osstell ISQ device (Osstell ISQ, W\&H, Sweden)

    immediately at time of implant insertion

Secondary Outcomes (2)

  • The width of bone gained

    3 months postoperative

  • The mean bone density around dental implants

    3 months postoperative

Study Arms (1)

Ridge splitting and osseodensification with simultaneous implant placement

EXPERIMENTAL
Device: Piezotomed ridge splitting and osseodensification

Interventions

Ridge expansion using piezotomed ridge splitting and osseodensification

Ridge splitting and osseodensification with simultaneous implant placement

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with good oral hygiene
  • Patients with long-span, narrow posterior edentulous mandibular area
  • Age limit range \[25 - 66 years\]
  • Patients who accept to participate in the study
  • Minimum height 10mm from the crest of the ridge till the upper border of inferior alveolar canal
  • Minimum ridge thickness = 3mm at the crestal region
  • If the patient is diabetic, should be controlled.

You may not qualify if:

  • Immunosuppressive/ autoimmune disease patients
  • Patients with osteoporosis
  • Lack of sufficient amount of keratinizing mucosa at the crest of the edentulous saddle
  • Patients with bleeding disorder disease
  • Ridge width less than 3 mm
  • Smokers
  • Patients having periodontal disease
  • The presence of a pathological lesion in the area of ridge splitting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Alexandria, 21411, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 17, 2023

Study Start

March 25, 2022

Primary Completion

March 4, 2023

Study Completion

March 5, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations