NCT04905758

Brief Summary

patients were randomly divided into Maxi-Z plus dental implant group versus Maxi-Z implant group

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

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

April 1, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2021

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

1.2 years

First QC Date

May 26, 2021

Last Update Submit

July 21, 2021

Conditions

Peri-implant MucositisDental Implant Failed

Keywords

platform switched implantsplatform matched implants

Outcome Measures

Primary Outcomes (2)

  • Implant mobility using Periotest M

    Periotest M values range from (-8 to 0). high values represent loose implant, while osseointegrated implants showed low values

    12 months

  • marginal bone level

    measured in mm using X-ray

    12 months

Secondary Outcomes (1)

  • pink estheic score

    12 months

Study Arms (2)

Maxi-Z plus dental implant

EXPERIMENTAL

platform switched dental implants

Procedure: platform switching

Maxi-Z dental implant

ACTIVE COMPARATOR

platform matched dental implants

Procedure: platform amtching

Interventions

platform switchingPROCEDURE

reduced implant abutment interface

Maxi-Z plus dental implant
platform amtchingPROCEDURE

matched implant abutment interface

Maxi-Z dental implant

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • good health
  • unrestorable, periodontal healthy teeth

You may not qualify if:

  • systemic disease
  • periodontal disease
  • presence of abscess

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry, kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 214312, Egypt

Location

MeSH Terms

Interventions

Dental Implant-Abutment Design

Intervention Hierarchy (Ancestors)

Dental Prosthesis DesignDental ProsthesisProsthodonticsDentistryTechnology, Dental

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Maxi-Z plus dental implant
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of oral medicine and periodontology

Study Record Dates

First Submitted

May 26, 2021

First Posted

May 28, 2021

Study Start

April 1, 2020

Primary Completion

June 9, 2021

Study Completion

June 15, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

after research results publishing will decide

Shared Documents
STUDY PROTOCOL
Time Frame
by the end of August 2021 for 6 months
Access Criteria
open access

Locations

EG(1)