NCT06487689

Brief Summary

The goal of this observational study is to investigate oral manifestations in patients with Chronic Kidney Disease (CKD) for early detection, that alterations play an important point for dental guide during the progression and type of treatment of CKD . An oral exam was performed for detection oral manifestations, age, smoking, alcoholic and oral hygiene habits were collected. The study has 3 groups under study: hemodialysis (HD), peritoneal dialysis (PD) and pre-dialysis (P-D)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
449

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

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

January 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
Last Updated

July 5, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 12, 2024

Last Update Submit

June 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Periodontal status

    periodontrogram (probe CP12)

    2 years

Secondary Outcomes (7)

  • Sex

    2 years

  • Age

    2 years

  • Type of CKD

    2 years

  • time with CKD

    2 years

  • time of treatment

    2 years

  • +2 more secondary outcomes

Study Arms (3)

Hemodyalisis

Peritoneal dyalisis

Pre-dyalisis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Population with Chronic Kidney Disease, in pre-dialysis, hemodialysis, peritoneal dialysis

You may qualify if:

  • Age ≥ 18 years and ≤ 80 years;
  • No change of medication in the last 3 months;
  • History of CKD comported by data laboratory (GRF\<60 ml/min/1.73m²).

You may not qualify if:

  • Age ≤ 18 years and ≥ 80 years;
  • Patients undergoing orthodontic therapy;
  • Patients taking drugs;
  • Patients changes the medication or introduced a new medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Barcelona

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

June 12, 2024

First Posted

July 5, 2024

Study Start

January 10, 2024

Primary Completion

March 15, 2024

Study Completion

May 25, 2024

Last Updated

July 5, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations