Diabetes Mellitus, Type 2NCT05814965
Association of Apical Periodontitis With Systemic Level of Inflammatory Markers : A Longitudinal Intervention Study
A study testing endodontic treatment in the form of root canal treatment, endodontic treatment and assessment of inflammatory marker in people with Diabetes Mellitus, Type 2 and Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
While cross-sectional studies have reported a significant association between diabetes and Apical Periodontics, prospective studies are scarce. This will be the first prospective interventional study to explore the cause-and-effect relation between AP and diabetes by assessment of levels of inflammatory markers in a… Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Apical Periodontitis
- What is being tested?
- endodontic treatment in the form of root canal treatment, endodontic treatment and assessment of inflammatory marker
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteIndia
- Study dates
- 5 Apr 2023to Dec 2025
- 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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients 30-55 year age group with minimum 20 natural teeth, with pulp necrosis confirmed by cold test and electric pulp test and radiographic evidence of periapical radiolucency with PAI score of ≥3 (24) or more in at least one mature tooth.
- control in the systemically healthy group will be selected to match participants in terms of age, sex, and BMI.
- control for participants with type 2 DM will be selected to additionally match with glycaemic control, drugs and dietary measures apart from other physical attributes.
Who cannot join
- Patients with clinical diagnosis of moderate to severe periodontitis (≥6 sites with probing depth ≥5 mm at separate teeth, with attachment loss and radiographic alveolar bone loss), Patients with immunosuppression, pregnancy, conditions requiring prophylactic antibiotics prior to dental treatment, bleeding disorders, medical conditions that may affect study participation (e.g., unstable cardiovascular disease) and chronic inflammatory conditions like rheumatoid
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PGIDS
Rohtak, Haryana, 124001
Dr. Sanjay Tewari, MDS, 01262283876, principalpgids@yahoo.in
About this study
While cross-sectional studies have reported a significant association between diabetes and Apical Periodontics, prospective studies are scarce. This will be the first prospective interventional study to explore the cause-and-effect relation between AP and diabetes by assessment of levels of inflammatory markers in a longitudinal setting. Periapical healing in diabetics and nondiabetics will be compared after root canal treatment to evaluate the role of various physical and metabolic attributes on endodontic outcomes.
Read the detailed description
This prospective longitudinal interventional study will be conducted on patients with radiographic evidence of AP in at least one teeth. Total of 280 patients will be selected from the pool of the patients referred to the Outpatient Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak. They will be equally divided into two broad groups either without any systemic disease (140 patients) or with type 2 DM.(140 Patients with DM). Each group further divided into 70 patients with AP and 70 control in a systemically healthy group (selected to match participants in age, sex and BMI). Similarly,70 patients with AP and 70 control for participants with type 2 DM will be selected to additionally match with glycaemic control, drugs, and dietary measures apart from other physical attributes.
Analysis of systemic inflammatory markers IL-1b, IL-6, TNF- α and hsCRP will be done at baseline in both healthy and diabetic participants. Root canal treatment will be done in all the participants with AP and assessment of periapical healing and change in inflammatory markers will be done at 3, 6, and 12-month follow-up.
Sample size: Sample size was estimated based on the difference in hsCRP level in patients with AP and healthy control. Effect size of 0.52 was calculated based on the mean difference and pooled SD of 0.91 and 1.75 respectively. Sample size of 58 per group was obtained at 80% power and 0.05 alpha level. Anticipating 20% dropout, total 70 patients per group (in 4 groups total 280 patients)will be recruited.
Root Canal treatment Access opening will be done after rubber dam isolation and administration of local anesthesia.
debridement of the pulp chamber will be done and all canal orifices will be identified.
Negotiation of canals will be done. Working length will be determined using root ZX apex locator and will be verified radiographically. Root canal treatment will be performed with protaper rotary instrument using standard protocol. Coronal 2/3rd pre-enlargement will be performed with S1 and S2 files and apical third will be prepared with S1 followed by S2 and suitable finishing files depending on the size of apical binding file. Irrigation will be carried out using 5 mL of a 5% NaOCl solution between files. After preparation, the root canals will be irrigated with 5 mL 17% EDTA for 3 minutes to remove smear layer, followed by 5 mL 5% NaOCl. The final irrigation will be done with 5 mL distilled water. Intracanal dressing of Calcium hydroxide will be applied for 7 days and obturation of canal will be performed after 7 days on 2nd visit. The root canals will be dried using paper points and filled with laterally condensed gutta-percha (Dentsply Maillefer) and AH plus resin-after manipulation following manufacturers' instructions. Gutta- percha will be cut with a heated instrument and vertically condensed right at the orifice opening of the canals. Final composite resin restoration will be performed following manufacturer instruction. All the posterior teeth will be metal/ceramic crown after the completion of root canal treatment.
Follow up Follow-up and clinical and radiographic examinations will be carried out after every three months for one year. Glycaemic control in diabetes patients will also be evaluated by HbA1c values at each follow-up interval.
- Conditions
- Diabetes Mellitus, Type 2, Apical Periodontitis
- Being tested
- endodontic treatment in the form of root canal treatment, endodontic treatment, assessment of inflammatory marker, inflammatory markers will be assessed along with metabolic markers assessment
- Keywords
- Apical Periodontitis, Diabetes mellitus, High sensitivity C-reactive protein, Tumor necrosis factor-alpha, Interleukin, Glycated hemoglobin
- Medical subject headings
- Diabetes Mellitus, Type 2, Periapical Periodontitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endodontic treatment in the form of root canal treatmentProcedure or surgery
Also called RCT
Patients will receive endodontic treatment, and inflammatory markers will be assessed
endodontic treatmentProcedure or surgery
Patients will receive endodontic treatment in the form of root canal treatment, and inflammatory markers will be assessed along with metabolic markers assessment
assessment of inflammatory markerDiagnostic test
assessment of inflammatory markers
inflammatory markers will be assessed along with metabolic markers assessmentDiagnostic test
inflammatory markers will be assessed along with metabolic markers assessment
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients with Apical periodontitis | Experimental | Diabetic patients with Apical periodontitis received Endodontics treatment in form of Root canal treatment and assessment of inflammatory and metabolic markers Receives: Procedure: endodontic treatment in the form of root canal treatment |
| Healthy patients with Apical periodontitis | Experimental | systemically healthy participants patients with Apical periodontitis received Endodontics treatment in the form of root canal treatment and assessment of inflammatory markers Receives: Procedure: endodontic treatment |
| Diabetic patients with out Apical periodontitis | Active comparator | systemic inflammatory markers along with metabolic markers will be assessed Receives: Diagnostic Test: inflammatory markers will be assessed along with metabolic markers assessment |
| Healthy participants without Apical periodontitis | Active comparator | systemic inflammatory markers will be assessed Receives: Diagnostic Test: assessment of inflammatory marker |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAI SCORE
PERIAPICAL INDEX RADIOGRAPHIC EVALUATION
Measured: 12 MONTHS
Interlukin 1B
INFLAMMATORY MARKER BY ELISA KIT
Measured: 12 MONTHS
IL 6
ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT
Measured: 12 MONTHS
TNF -ALPHA
ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT
Measured: 12 MONTHS
hs-CRP
ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start5 Apr 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Model description
- 280 patients 140 in DM (70 each with AP and 70 without AP) and 140 Systemically healthy (70 each with AP and 70 without AP)will be enrolled and compared for systemic markers .Subjects with AP will be provided Endodontics treatment and levels of markers will be assessed one year after Endodontics treatment. markers.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SANJAY TEWARI, Principal investigator, POST GRADUATE INSTITUTE OF DENTAL SCIENCES,ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814965
- Sponsor's protocol ID
- Dr. Sanjay Tewari 2023
- Status last verified
- Apr 2023
- First submitted
- 3 Apr 2023
- Last updated
- 18 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 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Apical Periodontitis With Systemic Level of Inflammatory Markers : A Longitudinal Intervention Study
- ClinicalTrials.gov ID
- NCT05814965
- Acronym / sponsor ID
- Dr. Sanjay Tewari 2023
- Conditions
- Diabetes Mellitus, Type 2, Apical Periodontitis
- Keywords
- Apical Periodontitis, Diabetes mellitus, High sensitivity C-reactive protein, Tumor necrosis factor-alpha, Interleukin, Glycated hemoglobin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 5 Apr 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 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.
While cross-sectional studies have reported a significant association between diabetes and Apical Periodontics, prospective studies are scarce. This will be the first prospective interventional study to explore the cause-and-effect relation between AP and diabetes by assessment of levels of inflammatory markers in a longitudinal setting. Periapical healing in diabetics and nondiabetics will be compared after root canal treatment to evaluate the role of various physical and metabolic attributes on endodontic outcomes.
Detailed description
This prospective longitudinal interventional study will be conducted on patients with radiographic evidence of AP in at least one teeth. Total of 280 patients will be selected from the pool of the patients referred to the Outpatient Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak. They will be equally divided into two broad groups either without any systemic disease (140 patients) or with type 2 DM.(140 Patients with DM). Each group further divided into 70 patients with AP and 70 control in a systemically healthy group (selected to match participants in age, sex and BMI). Similarly,70 patients with AP and 70 control for participants with type 2 DM will be selected to additionally match with glycaemic control, drugs, and dietary measures apart from other physical attributes.
Analysis of systemic inflammatory markers IL-1b, IL-6, TNF- α and hsCRP will be done at baseline in both healthy and diabetic participants. Root canal treatment will be done in all the participants with AP and assessment of periapical healing and change in inflammatory markers will be done at 3, 6, and 12-month follow-up.
Sample size: Sample size was estimated based on the difference in hsCRP level in patients with AP and healthy control. Effect size of 0.52 was calculated based on the mean difference and pooled SD of 0.91 and 1.75 respectively. Sample size of 58 per group was obtained at 80% power and 0.05 alpha level. Anticipating 20% dropout, total 70 patients per group (in 4 groups total 280 patients)will be recruited.
Root Canal treatment Access opening will be done after rubber dam isolation and administration of local anesthesia.
debridement of the pulp chamber will be done and all canal orifices will be identified.
Negotiation of canals will be done. Working length will be determined using root ZX apex locator and will be verified radiographically. Root canal treatment will be performed with protaper rotary instrument using standard protocol. Coronal 2/3rd pre-enlargement will be performed with S1 and S2 files and apical third will be prepared with S1 followed by S2 and suitable finishing files depending on the size of apical binding file. Irrigation will be carried out using 5 mL of a 5% NaOCl solution between files. After preparation, the root canals will be irrigated with 5 mL 17% EDTA for 3 minutes to remove smear layer, followed by 5 mL 5% NaOCl. The final irrigation will be done with 5 mL distilled water. Intracanal dressing of Calcium hydroxide will be applied for 7 days and obturation of canal will be performed after 7 days on 2nd visit. The root canals will be dried using paper points and filled with laterally condensed gutta-percha (Dentsply Maillefer) and AH plus resin-after manipulation following manufacturers' instructions. Gutta- percha will be cut with a heated instrument and vertically condensed right at the orifice opening of the canals. Final composite resin restoration will be performed following manufacturer instruction. All the posterior teeth will be metal/ceramic crown after the completion of root canal treatment.
Follow up Follow-up and clinical and radiographic examinations will be carried out after every three months for one year. Glycaemic control in diabetes patients will also be evaluated by HbA1c values at each follow-up interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 280 patients 140 in DM (70 each with AP and 70 without AP) and 140 Systemically healthy (70 each with AP and 70 without AP)will be enrolled and compared for systemic markers .Subjects with AP will be provided Endodontics treatment and levels of markers will be assessed one year after Endodontics treatment. markers.
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients with Apical periodontitis | Experimental | Procedure: endodontic treatment in the form of root canal treatmentDiabetic patients with Apical periodontitis received Endodontics treatment in form of Root canal treatment and assessment of inflammatory and metabolic markers |
| Healthy patients with Apical periodontitis | Experimental | Procedure: endodontic treatmentsystemically healthy participants patients with Apical periodontitis received Endodontics treatment in the form of root canal treatment and assessment of inflammatory markers |
| Diabetic patients with out Apical periodontitis | Active comparator | Diagnostic Test: inflammatory markers will be assessed along with metabolic markers assessmentsystemic inflammatory markers along with metabolic markers will be assessed |
| Healthy participants without Apical periodontitis | Active comparator | Diagnostic Test: assessment of inflammatory markersystemic inflammatory markers will be assessed |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients 30-55 year age group with minimum 20 natural teeth, with pulp necrosis confirmed by cold test and electric pulp test and radiographic evidence of periapical radiolucency with PAI score of ≥3 (24) or more in at least one mature tooth.
- control in the systemically healthy group will be selected to match participants in terms of age, sex, and BMI.
- control for participants with type 2 DM will be selected to additionally match with glycaemic control, drugs and dietary measures apart from other physical attributes.
Key exclusion criteria (1 listed)
- Patients with clinical diagnosis of moderate to severe periodontitis (≥6 sites with probing depth ≥5 mm at separate teeth, with attachment loss and radiographic alveolar bone loss), Patients with immunosuppression, pregnancy, conditions requiring prophylactic antibiotics prior to dental treatment, bleeding disorders, medical conditions that may affect study participation (e.g., unstable cardiovascular disease) and chronic inflammatory conditions like rheumatoid
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 |
|---|---|---|
| endodontic treatment in the form of root canal treatmentAlso: RCTPatients will receive endodontic treatment, and inflammatory markers will be assessed | Procedure or surgery | Diabetic patients with Apical periodontitis |
| endodontic treatmentPatients will receive endodontic treatment in the form of root canal treatment, and inflammatory markers will be assessed along with metabolic markers assessment | Procedure or surgery | Healthy patients with Apical periodontitis |
| assessment of inflammatory markerassessment of inflammatory markers | Diagnostic test | Healthy participants without Apical periodontitis |
| inflammatory markers will be assessed along with metabolic markers assessmentinflammatory markers will be assessed along with metabolic markers assessment | Diagnostic test | Diabetic patients with out Apical periodontitis |
Primary outcome
PAI SCORE
Time frame: 12 MONTHS
PERIAPICAL INDEX RADIOGRAPHIC EVALUATION
Interlukin 1B
Time frame: 12 MONTHS
INFLAMMATORY MARKER BY ELISA KIT
IL 6
Time frame: 12 MONTHS
ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT
TNF -ALPHA
Time frame: 12 MONTHS
ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT
hs-CRP
Time frame: 12 MONTHS
ESTIMATION OF NFLAMMATORY MARKER BY ELISA KIT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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.
SANJAY TEWARI principal investigator
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?
A study testing endodontic treatment in the form of root canal treatment, endodontic treatment and assessment of inflammatory marker in people with Diabetes Mellitus, Type 2 and Apical Periodontitis, 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 3 inclusion and 1 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 18 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SANJAY TEWARI, MDS (01262-283876, principalpgids@yahoo.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAI SCORE (time frame: 12 MONTHS). 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 18 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.