Oral Manifestations in Chronic Kidney Disease.

Oral Manifestations in Chronic Kidney Disease: Clinical Trial

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)

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Hemodyalysis; Pre-dyalisis; Peritoneal Dyalisis

• Study Type: Observational
• Enrollment (Actual): 449

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • University of Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Hemodyalisis
Peritoneal dyalisis
Pre-dyalisis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal status	periodontrogram (probe CP12)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex	qualitative variable: Male/Female	2 years
Age	nominal variable: years	2 years
Type of CKD	qualitative variable: pre-dialysis, peritoneal dialysis, hemodialysis	2 years
time with CKD	nominal variable: years	2 years
time of treatment	nominal variable: years	2 years
smoking and alcohol habits	qualitative variable: YES/NO	2 years
oral lesions	qualitative variable: uremic odor, xerostomia, taste disorder, petechiae, tongue coating	2 years

Collaborators and Investigators

• Sponsor: José López Lopez

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): May 25, 2024

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Stomatognathic Diseases; Mouth Diseases; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Oral Manifestations
• Other Study ID Numbers: Renal-Oral

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No