Apical PeriodontitisNCT06446011
Effects of RCT on Periapical Healing, Inflammatory Markers, and Kidney Function Indicators in CKD Patients With AP
A study testing root canal treatment in Ckd patients and root canal treatment in healthy patients in people with Apical Periodontitis and Chronic Kidney Diseases, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The purpose of this prospective study is to determine the effect of non-surgical root canal treatment in chronic kidney disease patients and healthy patients with apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis, Chronic Kidney Diseases
- What is being tested?
- root canal treatment in Ckd patients and root canal treatment in healthy patients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIndia
- Study dates
- 12 Jul 2023to 30 Aug 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1- Known patient of Chronic Kidney Disease [CKD Stages 1,2,3,4,5 with mature permanent teeth.
- 2. Age18year or older . 3. ≥ to 12 natural teeth (excluding 3rd molars) 4 The periapical index (PAI) was used to evaluate the periapical status patients with PAI ≥3 are included in the study.
Who cannot join
- Patients having systemic disorders other than chronic kidney disease (e.g HIV; Diabetes mellitus; Coronary heart disease; no history of secondary hyperparathyroidism)
- Patients with periodontitis , pocket depth and CAL>5mm( stage 3 ,4) will be excluded.
- Pregnancy; lactation \& contraceptives.
- Patients taking antibiotics, statins, corticosteroids and aspirin which can affect the level of inflammatory markers in past one month.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PGIDS
Rohtak, Haryana, 121004
HIMANSHI VERMA, MDS, 7042836872, himanshiverma706@gmail.com
SHWETA MITTAL, MDS, 9255596960, shwetagoeleno@gmail.com
About this study
Official title: Potential Effects of Non-surgical Endodontic Treatment on Periapical Healing, Inflammatory Markers, and Kidney Function Indicators in Chronic Kidney Disease Patients With Apical Periodontitis- Interventional Study.
The purpose of this prospective study is to determine the effect of non-surgical root canal treatment in chronic kidney disease patients and healthy patients with apical periodontitis.
Read the detailed description
It has been found that there is an association between prevalence of odontogenic infection and systemic diseases. An elevated level of systemic cytokines has been observed in conjunction with both AP and CKD . The proinflammatory status and impaired immune response associated with systemic diseases (chronic kidney disease ) can affect the reparative response of the dental pulp and periapical healing. One study observed significant positive relation between number of diagnosed AP and urea serum level . A 4.35-mg/dL increase in the urea serum level could be expected per 1-unit increase in the number of teeth with AP. Improving oral health care through nonsurgical endodontic treatment(NSET) may improve the systemic inflammatory status and improve renal function.
The aim of this prospective study is to determine the effect of non-surgical root canal treatment in chronic kidney disease patients and healthy patients with apical periodontitis
- Clinical and radiographic success rate will be considered as primary outcome, will be checked at baseline,6months,12months follow up.Periapical status will be checked according to periapical index given by Orstavik
- Reduction in inflammatory(hsCRP) and kidney makers(serum urea , creatinine , eGFR) will be considered as secondary outcome, will be checked at baseline,3months,6months follow up.
- Conditions
- Apical Periodontitis, Chronic Kidney Diseases
- Being tested
- root canal treatment in Ckd patients, root canal treatment in healthy patients
- Medical subject headings
- Periapical Periodontitis, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal treatment in Ckd patientsProcedure or surgery
root canal treatment in teeth with apical periodontitis to observe periapical healing , and change in eGFR ,blood urea and creatinine and HSCRP
root canal treatment in healthy patientsProcedure or surgery
root canal treatment in teeth with apical periodontitis to observe periapical healing and change in HSCRP
| Study group | Role | What they receive |
|---|---|---|
| Chronic kidney disease group | Experimental | Root canal treatment will be performed in teeth with apical periodontitis in chronic kidney disease patients and change in PAI score, eGFR and systemic markers will be checked. Receives: Procedure: root canal treatment in Ckd patients |
| Healthy group | Active comparator | Root canal treatment will be performed in teeth with apical periodontitis in healthy patients and change in PAI score and systemic markers will be checked Receives: Procedure: root canal treatment in healthy patients |
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: 12MONTHS
Secondary outcomes (4)
eGFR
BY BLOOD SAMPLE measured in mL/min/1.73m2
Measured: 3-6MONTHS
serum creatinine
BY BLOOD SAMPLE measured in mg/dL
Measured: 3-6MONTHS
hs-CRP
HIGH SENSITIVE C-reactive protein measured by ELISA kit in mg/L
Measured: 3-6MONTHS
Blood urea
measured by collecting blood sample in mg/dL
Measured: 3-6MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start12 Jul 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Apical PeriodontitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HIMANSHI VERMA, MDS, Principal investigator, PGIDS,ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446011
- Sponsor's protocol ID
- Himanshi Verma
- Status last verified
- Nov 2023
- First submitted
- 7 Dec 2023
- Last updated
- 6 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verma H, Mittal S, Tewari S, Jain D, Kumar V, Duhan J, Sangwan P, Arora M, Chauhan N. Effects of Non-Surgical Endodontic Treatment on Inflammatory and Renal Markers in Chronic Kidney Disease and Healthy Patients With Apical Periodontitis. Aust Endod J. 2026 Sep 28. doi: 10.1111/aej.70125. Online ahead of print.
PubMed 42806576
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Effects of Non-surgical Endodontic Treatment on Periapical Healing, Inflammatory Markers, and Kidney Function Indicators in Chronic Kidney Disease Patients With Apical Periodontitis- Interventional Study.
- ClinicalTrials.gov ID
- NCT06446011
- Acronym / sponsor ID
- Himanshi Verma
- Conditions
- Apical Periodontitis, Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 6 Jun 2024 (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.
The purpose of this prospective study is to determine the effect of non-surgical root canal treatment in chronic kidney disease patients and healthy patients with apical periodontitis.
Detailed description
It has been found that there is an association between prevalence of odontogenic infection and systemic diseases. An elevated level of systemic cytokines has been observed in conjunction with both AP and CKD . The proinflammatory status and impaired immune response associated with systemic diseases (chronic kidney disease ) can affect the reparative response of the dental pulp and periapical healing. One study observed significant positive relation between number of diagnosed AP and urea serum level . A 4.35-mg/dL increase in the urea serum level could be expected per 1-unit increase in the number of teeth with AP. Improving oral health care through nonsurgical endodontic treatment(NSET) may improve the systemic inflammatory status and improve renal function.
The aim of this prospective study is to determine the effect of non-surgical root canal treatment in chronic kidney disease patients and healthy patients with apical periodontitis
- Clinical and radiographic success rate will be considered as primary outcome, will be checked at baseline,6months,12months follow up.Periapical status will be checked according to periapical index given by Orstavik
- Reduction in inflammatory(hsCRP) and kidney makers(serum urea , creatinine , eGFR) will be considered as secondary outcome, will be checked at baseline,3months,6months follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease group | Experimental | Procedure: root canal treatment in Ckd patientsRoot canal treatment will be performed in teeth with apical periodontitis in chronic kidney disease patients and change in PAI score, eGFR and systemic markers will be checked. |
| Healthy group | Active comparator | Procedure: root canal treatment in healthy patientsRoot canal treatment will be performed in teeth with apical periodontitis in healthy patients and change in PAI score and systemic markers will be checked |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1- Known patient of Chronic Kidney Disease [CKD Stages 1,2,3,4,5 with mature permanent teeth.
- 2. Age18year or older . 3. ≥ to 12 natural teeth (excluding 3rd molars) 4 The periapical index (PAI) was used to evaluate the periapical status patients with PAI ≥3 are included in the study.
Key exclusion criteria (4 listed)
- Patients having systemic disorders other than chronic kidney disease (e.g HIV; Diabetes mellitus; Coronary heart disease; no history of secondary hyperparathyroidism)
- Patients with periodontitis , pocket depth and CAL>5mm( stage 3 ,4) will be excluded.
- Pregnancy; lactation \& contraceptives.
- Patients taking antibiotics, statins, corticosteroids and aspirin which can affect the level of inflammatory markers in past one month.
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 |
|---|---|---|
| root canal treatment in Ckd patientsroot canal treatment in teeth with apical periodontitis to observe periapical healing , and change in eGFR ,blood urea and creatinine and HSCRP | Procedure or surgery | Chronic kidney disease group |
| root canal treatment in healthy patientsroot canal treatment in teeth with apical periodontitis to observe periapical healing and change in HSCRP | Procedure or surgery | Healthy group |
Primary outcome
Periapical Index(PAI)
Time frame: 12MONTHS
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
4 secondary outcomes
eGFR
Time frame: 3-6MONTHS
serum creatinine
Time frame: 3-6MONTHS
hs-CRP
Time frame: 3-6MONTHS
Blood urea
Time frame: 3-6MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Derived from this study: PubMed 42806576Verma H, Mittal S, Tewari S, Jain D, Kumar V, Duhan J, Sangwan P, Arora M, Chauhan N. Effects of Non-Surgical Endodontic Treatment on Inflammatory and Renal Markers in Chronic Kidney Disease and Healthy Patients With Apical Periodontitis. Aust Endod J. 2026 Sep 28. doi: 10.1111/aej.70125. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
HIMANSHI VERMA, MDS principal investigator
PGIDS,ROHTAK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root canal treatment in Ckd patients and root canal treatment in healthy patients in people with Apical Periodontitis and Chronic Kidney Diseases, 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SHWETA MITTAL, MDS (9255596960, shwetagoelendo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periapical Index(PAI) (time frame: 12MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06446011, which also lists 1 linked publication.
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 6 Jun 2024.