NCT05739461

Brief Summary

The objective of this retrospective study with 5-year follow-up was to compare crestal bone loss (CBL) and buccal bone thickness (BBT) around triangular cross-section neck (TN) to round neck (RN) implants retaining mandibular overdentures, using cone-beam computed tomography

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

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

September 22, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

February 12, 2023

Last Update Submit

February 12, 2023

Conditions

Keywords

: buccal bone thicknesscrestal bone lossneck designperi-implant soft tissuetriangular cross-section neck

Outcome Measures

Primary Outcomes (2)

  • comparison of crestal bone loss

    February 2023

  • comparison of buccal bone thickness

    February 2023

Study Arms (2)

triangular cross-section neck implant

Other: Dental implant

round cross-section neck implant

Other: Dental implant

Interventions

Dental implants with triangular cross-section neck design

round cross-section neck implanttriangular cross-section neck implant

Eligibility Criteria

Age59 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healty patients who was inserted dental implants with two different designs

You may qualify if:

  • Patients over 18 years old.
  • Mandibular total edentulism.
  • Presence of sufficient residual bone width (\>5 mm) and length (\>10 mm).
  • Sufficient keratinized gingiva crestally (≥4 mm).
  • Sufficient interarch space.
  • Sufficient vestibular depth.
  • Patients had their teeth extracted at least three months before surgery.

You may not qualify if:

  • Patients with any systemic disease or condition that can/could compromise osteointegration (cancer, diabetes mellitus, osteopo- rosis, and cardiovascular diseases).
  • Presence of any drug use that could affect bone metabolism.
  • Presence of immunocompromising conditions.
  • Presence of any pathology in the mandible.
  • Allergy to any drugs used in the postoperative period.
  • Patients who are smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

February 12, 2023

First Posted

February 22, 2023

Study Start

September 22, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations