NCT05972447

Brief Summary

The goal of this \[clinical trial\] is to \[To evaluate both the clinical and radiographical outcome on osteointegration and peri-implant bone density when using ultra wide diameter implant placed immediately in molar extraction socket\]

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 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

May 20, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

July 17, 2023

Last Update Submit

July 24, 2023

Conditions

Keywords

UWD implants

Outcome Measures

Primary Outcomes (4)

  • the mean value of implant stability

    The implant stability was measured by implant stability meter (Osstell™) immediately postoperative and at 6 months.

    up to 6months

  • the mean value of peri-implant bone density

    Radiographic evaluation of the bone density around each implant was done using OnDemand3D™.

    up to 9 months

  • the mean value of Marginal bone loss

    marginal bone levels were calculated from the reconstructed corrected sagittal views by drawing a line parallel to the implant serration extending from the crestal bone to the apical end of the implant. Average readings of the two sides at each interval were calculated and tabulated for statistical analysis.

    up to 9months

  • the mean of peri-implant probing depth

    Probing depth was assessed according to Gallagher and Silver Probing pocket depth refers to the distance between the gingival margin and the bottom of the pocket

    up to 9 months

Study Arms (1)

non-restorable mandibular molar teeth

OTHER

patients with non restorable mandibular molar teeth without any periapical pathosis to be extracted and implanted immediately using ultrawide diameter dental implants

Procedure: Immediate implant placement of Ultrawide diameter dental implants

Interventions

immediate placement of ultrawide diameter dental implants in a fresh extraction socket of mandibular molar teeth

Also known as: Ultrawide diameter dental implants
non-restorable mandibular molar teeth

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients ranging from 20-40 years.
  • Adequate bone beyond teeth apices without jeopardizing any anatomical structure.
  • Non-restorable mandibular molar teeth.
  • Available bone with adequate width and buccolingual dimensions.
  • Peri-implant bone defect should be 2mm or lesser.

You may not qualify if:

  • Smokers.
  • Medically compromised patients like uncontrolled diabetes and coagulation disorders.
  • Tooth with periapical pathosis or bony defects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University

Alexandria, 20200, Egypt

Location

Study Officials

  • Gaafar N Elhalawani

    Alexandria University

    STUDY DIRECTOR

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
principle investigator

Study Record Dates

First Submitted

July 17, 2023

First Posted

August 2, 2023

Study Start

May 20, 2021

Primary Completion

January 12, 2022

Study Completion

March 3, 2022

Last Updated

August 2, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations