NCT06580626

Brief Summary

42 patients will be selected from the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of missed single tooth or multiple teeth in posterior mandible by dental implant in horizontally atrophic ridge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

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

July 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

August 28, 2024

Last Update Submit

August 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Alveolar ridge width.

    Overall width of the ridge was evaluated preoperatively, after implant placement immediately, after 6, and 12 months postoperative

    1 year

Study Arms (3)

decompression group

EXPERIMENTAL
Procedure: decompression technique

Ethoss group

EXPERIMENTAL
Procedure: guided bone regenaration using Ethoss

ridge splitting group

EXPERIMENTAL
Procedure: ridge splitting technqiue

Interventions

14 implants will be placed in patients of missing single tooth or multiple teeth in posterior mandible with subsequent horizontal ridge augmentation by decompression technique.

decompression group

14 implants will be placed in patients of missing single tooth or multiple teeth in posterior mandible with subsequent horizontal ridge augmentation by guided bone regeneration using β-TCP/CS synthetic bone substitute.

Ethoss group

14 implants will be placed in patients of missing single tooth or multiple teeth in posterior mandible with subsequent horizontal ridge augmentation by ridge splitting technique using piezosurgery.

ridge splitting group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient's cooperation, motivation and good oral hygiene.
  • Patient medically free from systemic diseases that absolutely contraindicate implant surgery.
  • Moderately atrophic posterior mandibular alveolar ridge width (more than 4 mm), with minimum 10 mm height.
  • Free from history of bruxism / parafunctional habits.

You may not qualify if:

  • Patients with local pathological disease such as cyst, tumor at the planned surgical site.
  • Pregnant patients.
  • Heavy smoker patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heba Elsheikh

Al Mansurah, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of oral and maxillofacial surgery

Study Record Dates

First Submitted

August 28, 2024

First Posted

August 30, 2024

Study Start

July 1, 2023

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

August 30, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations