NCT06848855

Brief Summary

The goal of this observational study is to evaluate the effects of proton pump inhibitors (PPIs) on the surrounding bone and the survival of dental implants. The main questions it aims to answer are: Does PPI use affect the survival rate of dental implants? Does PPI use influence crestal bone loss and fractal dimension (FD) of the surrounding bone?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 23, 2025

Last Update Submit

February 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fractal Dimension Value

    Fractal analysis values were calculated on radiographs within 1 month after the data collection of the patients.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study was conducted with patients who had a history of PPI use for more than six months and systemically healthy individuals who had undergone regular clinical and radiological follow-ups after dental implant placement at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Kocaeli University.

You may qualify if:

  • Being over 18 years old,
  • Having a history of PPI use for more than six months,
  • Having at least one bone-level and axially placed dental implant in the maxilla or mandible,
  • Having a minimum of one year elapsed since the prosthetic restoration following dental implant placement,
  • Having undergone routine clinical follow-ups and radiological evaluations with periapical radiographs taken using the parallel cone technique after dental implant placement.

You may not qualify if:

  • Individuals with a history of PPI use for less than six months,
  • Individuals with periapical radiographs of low image quality or with artifacts,
  • Individuals for whom the regions selected for fractal analysis on periapical radiographs are not appropriately sized,
  • Individuals who have not undergone routine clinical and radiographic follow-ups.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, 41040, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 23, 2025

First Posted

February 27, 2025

Study Start

November 1, 2023

Primary Completion

April 15, 2024

Study Completion

May 15, 2024

Last Updated

February 27, 2025

Record last verified: 2025-02

Locations