Chronic Kidney DiseasesNCT05818657
Association of Apical Periodontitis With Chronic Kidney Disease
An observational study of Chronic Kidney Diseases and Periapical Lesions, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
This investigation is aimed to assess the prevalence and severity of apical periodontitis (AP) in different stages of CKD patients and its impact on the systemic (nutritional and inflammatory) markers was compared to healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Periapical Lesions
- What is being tested?
- levels of CKD markers, Oral health status, apical periodontitis and systemic inflammatory marker, Oral health status, apical periodontitis
- Type of treatment
- Pill or oral medicine
- How many people
- 210 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CKD patients of different levels (Stage 1 to Stage 5) with age and gender matched controls will be enrolled in the study.
Who may be able to join
- Known patient of CKD Stages 1,2,3,4 \& 5 with estimated glomerular filtration rate [eGFR; MDRD] with mature permanent teeth.
- > 18 years
- > 8 natural teeth.
- Complete medical \& dental history including panoramic radiographs of maxilla \& mandible
Who cannot join
- Patients having systemic disorders other than CKD (eg HIV, Diabetes mellitus, Coronary heart disease, history of secondary hyperparathyroidism).
- Pregnancy, lactation \& contraceptives.
- Systemic conditions that contra indicates dental treatment.
- Use of antibiotics \& anti-inflammatory in last 3 months
- Need for antibiotic prophylaxis.
- Hepatitis C and B virus.
- Patients on steroids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of of Apical Periodontal in Patients Chronic Kidney Disease & Its Association With Markers of Kidney Disease.
This investigation is aimed to assess the prevalence and severity of apical periodontitis (AP) in different stages of CKD patients and its impact on the systemic (nutritional and inflammatory) markers was compared to healthy individuals.
Read the detailed description
105 CKD patients (35 early (EG), 35pre-dialysis (PDG) and 35 hemodialysis (HDG)groups and 105 age and gender matched healthy controls were assessed for prevalence and severity of apical periodontitis and oral disease burden . Inflammatory (hsCRP and ferritin) and nutritional (urea and creatinine) markers were estimated and eGFR was calculated for the study population. Logistic regression was used to determine the possible association between CKD and AP in study population and Linear regression was performed to evaluate the possible association between systemic markers and endodontic burden (EB) in experimental group.
- Conditions
- Chronic Kidney Diseases, Periapical Lesions
- Being tested
- levels of CKD markers, Oral health status, apical periodontitis, systemic inflammatory marker, Oral health status, apical periodontitis
- Keywords
- Apical Periodontitis, Root Canal Treatment
- Medical subject headings
- Renal Insufficiency, Chronic, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levels of CKD markers, Oral health status, apical periodontitisBiological
To observe levels of CKD markers :Levels of serum keratinise ,urea, eGFR, and assessment of Oral health status, apical periodontitis
systemic inflammatory marker, Oral health status, apical periodontitisBiological
estimation of hs-CRP levels, and assessment of Oral health status, apical periodontitis
| Study group | Role | What they receive |
|---|---|---|
| Group-A CKD patients | Prevalence of apical periodontitis will be checked and non-surgical root canal treatment will be given to the patients with apical periodontitis and change in PAI score, eGFR \& Systemic markers will be checked Receives: Biological: levels of CKD markers, Oral health status, apical periodontitis | |
| Group-B Healthy individuals | Prevalence of apical periodontitis will be checked and non-surgical root canal treatment will be given to the patients with apical periodontitis and change in PAI score, eGFR \& Systemic markers will be checked Receives: Biological: systemic inflammatory marker, Oral health status, apical periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical Index(PAI)
Periodical status will be assessed in periodical radiograph and scoring of periapical index will be done according to size and periphery of peri-apical radiolucency with coding 1 to 5
Measured: 1 year
eGFR
BY BLOOD SAMPLE measured in mL/min/1.73m2
Measured: 1 year
serum creatinine
BY BLOOD SAMPLE measured in mg/dL
Measured: 1 year
hs-CRP
HIGH SENSITIVE C-reactive protein measured by ELISA kit in mg/L
Measured: 1 year
Blood urea
measured by collecting blood sample in mg/dL
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Dec 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Shweta Mittal, MDS, Study director, Post Graduate Institute Of Dental Sciences, Rohtak.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818657
- Sponsor's protocol ID
- Dr. Jyoti Lamba
- Status last verified
- Apr 2023
- First submitted
- 11 Dec 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of of Apical Periodontal in Patients Chronic Kidney Disease & Its Association With Markers of Kidney Disease.
- ClinicalTrials.gov ID
- NCT05818657
- Acronym / sponsor ID
- Dr. Jyoti Lamba
- Conditions
- Chronic Kidney Diseases, Periapical Lesions
- Keywords
- Apical Periodontitis, Root Canal Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation is aimed to assess the prevalence and severity of apical periodontitis (AP) in different stages of CKD patients and its impact on the systemic (nutritional and inflammatory) markers was compared to healthy individuals.
Detailed description
105 CKD patients (35 early (EG), 35pre-dialysis (PDG) and 35 hemodialysis (HDG)groups and 105 age and gender matched healthy controls were assessed for prevalence and severity of apical periodontitis and oral disease burden . Inflammatory (hsCRP and ferritin) and nutritional (urea and creatinine) markers were estimated and eGFR was calculated for the study population. Logistic regression was used to determine the possible association between CKD and AP in study population and Linear regression was performed to evaluate the possible association between systemic markers and endodontic burden (EB) in experimental group.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-A CKD patients | – | Biological: levels of CKD markers, Oral health status, apical periodontitisPrevalence of apical periodontitis will be checked and non-surgical root canal treatment will be given to the patients with apical periodontitis and change in PAI score, eGFR \& Systemic markers will be checked |
| Group-B Healthy individuals | – | Biological: systemic inflammatory marker, Oral health status, apical periodontitisPrevalence of apical periodontitis will be checked and non-surgical root canal treatment will be given to the patients with apical periodontitis and change in PAI score, eGFR \& Systemic markers will be checked |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CKD patients of different levels (Stage 1 to Stage 5) with age and gender matched controls will be enrolled in the study.
Key inclusion criteria (4 listed)
- Known patient of CKD Stages 1,2,3,4 \& 5 with estimated glomerular filtration rate [eGFR; MDRD] with mature permanent teeth.
- > 18 years
- > 8 natural teeth.
- Complete medical \& dental history including panoramic radiographs of maxilla \& mandible
Key exclusion criteria (7 listed)
- Patients having systemic disorders other than CKD (eg HIV, Diabetes mellitus, Coronary heart disease, history of secondary hyperparathyroidism).
- Pregnancy, lactation \& contraceptives.
- Systemic conditions that contra indicates dental treatment.
- Use of antibiotics \& anti-inflammatory in last 3 months
- Need for antibiotic prophylaxis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levels of CKD markers, Oral health status, apical periodontitisTo observe levels of CKD markers :Levels of serum keratinise ,urea, eGFR, and assessment of Oral health status, apical periodontitis | Biological | Group-A CKD patients |
| systemic inflammatory marker, Oral health status, apical periodontitisestimation of hs-CRP levels, and assessment of Oral health status, apical periodontitis | Biological | Group-B Healthy individuals |
Primary outcome
Periapical Index(PAI)
Time frame: 1 year
Periodical status will be assessed in periodical radiograph and scoring of periapical index will be done according to size and periphery of peri-apical radiolucency with coding 1 to 5
eGFR
Time frame: 1 year
BY BLOOD SAMPLE measured in mL/min/1.73m2
serum creatinine
Time frame: 1 year
BY BLOOD SAMPLE measured in mg/dL
hs-CRP
Time frame: 1 year
HIGH SENSITIVE C-reactive protein measured by ELISA kit in mg/L
Blood urea
Time frame: 1 year
measured by collecting blood sample in mg/dL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Shweta Mittal, MDS study director
Post Graduate Institute Of Dental Sciences, Rohtak.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Periapical Lesions, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periapical Index(PAI) (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.