NCT05512273

Brief Summary

The preparation of the implant site has a major influence on the success rate and long-term survival of dental implants. Piezoelectric devices and special implant drilling inserts are now emerging to replace conventional drills.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 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

November 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

7 months

First QC Date

August 17, 2022

Last Update Submit

August 20, 2022

Conditions

Implant Osteotomy

Outcome Measures

Primary Outcomes (3)

  • Time of surgery

    Average surgical times for implant site was estimated

    through operation completion

  • Change in implant stability

    ISQ was measured using ostell device

    at baseline and 4 months

  • Change in bone density

    Mean bone density using CBCT

    at baseline and 4 months

Study Arms (2)

Study

EXPERIMENTAL
Procedure: Piezosurgery assisted osteotomy

Control

ACTIVE COMPARATOR
Procedure: Conventional drilling osteotomy

Interventions

Piezosurgery assisted osteotomyPROCEDURE

Sequential osteotomy drilling was done using mectron piezosurgery implant drilling protocol

Study
Conventional drilling osteotomyPROCEDURE

bone osteotomy for implant placement was done following the BEGO Semados RS/RSX TrayPlus conventional drilling

Control

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with bilateral missing premolars
  • Remaining bone height more ≥ 10mm.
  • Remaining bone width ≥ 6mm

You may not qualify if:

  • patients that smoke more than 10 cigarettes/day
  • Patients with uncontrolled systemic disease.
  • Presence of bone pathology within the future osteotomy site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beirut Arab University

Beirut, 11-5020, Lebanon

Location

Related Publications (1)

  • Arakji H, Osman E, Aboelsaad N, Shokry M. Evaluation of implant site preparation with piezosurgery versus conventional drills in terms of operation time, implant stability and bone density (randomized controlled clinical trial- split mouth design). BMC Oral Health. 2022 Dec 3;22(1):567. doi: 10.1186/s12903-022-02613-4.

    PMID: 36463145DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Split mouth
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer of DPH and Clinical statistician

Study Record Dates

First Submitted

August 17, 2022

First Posted

August 23, 2022

Study Start

November 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

August 23, 2022

Record last verified: 2022-08

Locations

LE(1)