PERIAPICAL LESIONSNCT05609747
Effect of NSRCT on HbA1c and Inflammatory Markers in Healthy and Type 2 Diabetes Patients With Apical Periodontitis
A study testing Nonsurgical root canal therapy in people with PERIAPICAL LESIONS, run by Postgraduate Institute of Dental Sciences Rohtak at 2 sites in India.
Trial summary
To the best of knowledge, only 2 prospective studies, and 1 cross-sectional study have been reported which have seen the periapical healing after non surgical endodontic treatment in diabetic patients and their effect on HbA1c. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PERIAPICAL LESIONS
- What is being tested?
- Nonsurgical root canal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesIndia
- Study dates
- 27 Dec 2021to 30 Dec 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Known patient of type 2 diabetes mellitus with HbA1c ≥6.5 %. Age between 30 to 65 years. Mature permanent posterior tooth having apical periodontitis requiring primary root canal treatment.
- No evidence of systemic diseases other than diabetes being a risk factor for apical periodontitis.
- A radiographic evidence of periapical radiolucency (minimum size,≥2mm x2mm) and a diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests.
- No antibiotic therapy within the preceding one month.
Who cannot join
- Teeth with procedural errors, cracks, fractured teeth. patients with previously endodontically treated teeth with periapical radiolucencies.
- Teeth that were not suitable for rubber dam isolation. smokers, pregnant patients. Patients with moderate and severe periodontitis. Systemic diseases other than diabetes being a risk factor for apical periodontitis.
- Immunocompromised patients.
Trial locations and contacts
2 sites in 1 country.
India2 sites
PGIDS
Rohtak, Haryana, 124001
Post Graduate Institute of Dental Science
Rohtak, Haryana, 124001
About this study
Official title: Effect of Non-Surgical Root Canal Treatment (NSRCT) on HbA1c and Inflammatory Markers in Healthy and Type 2 Diabetes Patients With Apical Periodontitis
To the best of knowledge, only 2 prospective studies, and 1 cross-sectional study have been reported which have seen the periapical healing after non surgical endodontic treatment in diabetic patients and their effect on HbA1c.
Because of the inconsistencies in data available from the literature and considering the limitations of cross-sectional studies, further studies, especially using a prospective design, are required.
So, aim is to investigate the effects of non surgical endodontic treatment on healing and systemic inflammation in individuals with and without diabetes.
Read the detailed description
Both the systematic review concluded that diabetics have significantly higher prevalence of RFT with RPL. An umbrella review concluded that DM is associated with the outcome of RCT and can be considered as a pre operative prognostic factor.
AP may contribute to low grade systemic inflammation associated with a generalized increase in systemic inflammatory mediators such as C-reactive protein (CRP), interleukin (IL)-1, IL-2, IL-6 and Immunoglobulin (IgA, IgG and IgM) levels .
It is already established that Diabetes mellitus (DM) and periodontitis are highly prevalent non-communicable diseases worldwide and yet they are closely inter-connected with common risk factors and plausibility of increased levels of systemic inflammation. It is evident that periodontitis significantly increases the risk of cardiovascular and renal complications in patients with type 2 diabetes mellitus (T2DM) . Higher serum high-sensitivity C-reactive protein (hsCRP) levels were reported in individuals with AP when compared to healthy controls . Also, there was a positive correlation of increased serum hsCRP levels with increasing severity of AP . A meta-analysis concluded that patients with AP had higher peripheral blood levels of CRP than controls and recommended the need for further studies to evaluate whether the treatment of AP can reduce serum CRP levels . Root canal treatment can reduce systemic inflammation and early endothelial dysfunction.
There is no published prospective interventional study evaluating the effect of root canal treatment on serum hsCRP levels in diabetic patients with AP.
Therefore, the aim of this study is to assess the impact of root canal treatment on HbA1c and serum hsCRP levels in diabetic adults with AP in comparison to healthy patients with AP.
- Conditions
- PERIAPICAL LESIONS
- Being tested
- Nonsurgical root canal therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonsurgical root canal therapyProcedure or surgery
Also called Root canal treatment
After administration of LA and rubber dam isolation, acess cavity will be prepared using carbide burs in high speed hand piece with copious irrigation. Working length will be determined using root ZX apex locator and will be verified radiographically. Canal preparation will be done with protaper rotary instruments in which Sx to S2 will be used to shape the canals and F1 and F2 will be used to finish until the apex. 5ml of 5.25% NaOCl will be used as irrigant after each instrument. After instrumentation , the canals will be irrigated with 5.0 ml of 17% EDTA for 1minute followed by irrigation with 5.0 ml of 5.25% NaOCl. Canals will be dried with absorbent paper points, filled with calcium hydroxide paste and access cavity will be restored with IRM. Patients will be recalled after 1 week.At the next appointment, after paste removal, copious irrigation with 5.25% NaOCl will be done and canals will be dried with paper points. Canals will be obturated with Gutta-Percha and ZOE based sealer.
| Study group | Role | What they receive |
|---|---|---|
| TYPE 2 DIABETIC PATIENTS | Experimental | NON SURGICAL ROOT CANAL TREATMENT Receives: Procedure: Nonsurgical root canal therapy |
| HEALTHY CONTROL GROUP PATIENTS | Experimental | NON SURGICAL ROOT CANAL TREATMENT Receives: Procedure: Nonsurgical root canal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic index (HbA1c) levels
A hemoglobin A1C (HbA1C) test is a blood test that shows what your average blood sugar (glucose) level was over the past two to three months. A normal HbA1C level is below 5.7%, a level of 5.7% to 6.4% indicates prediabetes, and a level of 6.5% or more indicates diabetes
Measured: Baseline to one year
high sensitivity C- reactive protein- hsCRP.
High-sensitivity C-reactive protein (hsCRP) (unit- mg/L)is a marker of inflammation that predicts incident myocardial infarction, stroke, peripheral arterial disease, and sudden cardiac death among healthy individuals with no history of cardiovascular disease, and recurrent events and death in patients with acute or stable coronary syndromes. hsCRP confers additional prognostic value at all levels of cholesterol, Framingham coronary risk score, severity of the metabolic syndrome, and blood pressure, and in those with and without subclinical atherosclerosis. hsCRP levels of less than 1, 1 to 3, and greater than 3 mg/L are associated with lower, moderate, and higher cardiovascular risks, respectively.
Measured: Baseline to one year
Secondary outcomes (1)
Clinical and Radiographic success
Absence of periapical alterations (radiolucency at furcal or periapical region) Scoring of each tooth will be done according to the following five point scale (PAI)
Score Description
- Normal Periapical structure
- Small changes in bone structure
- Changes in bone structure with some mineral loss
- Periodontitis with well defined radiolucent area
- Severe periodontitis with exacerbating feature
Lesions with a PAI score < 2 was considered as healed/healing.
Measured: Baseline to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start27 Dec 2021
- Primary completion27 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PERIAPICAL LESIONSStudies 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjay Tewari, Postgraduate Institute of Dental Sciences Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609747
- Sponsor's protocol ID
- PGIDS/BHRC/22/06/ NIKITA GARG
- Status last verified
- Nov 2022
- First submitted
- 30 Oct 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-Surgical Root Canal Treatment (NSRCT) on HbA1c and Inflammatory Markers in Healthy and Type 2 Diabetes Patients With Apical Periodontitis
- ClinicalTrials.gov ID
- NCT05609747
- Acronym / sponsor ID
- PGIDS/BHRC/22/06/ NIKITA GARG
- Conditions
- PERIAPICAL LESIONS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 27 Dec 2021 (actual)
- Primary completion
- 27 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 8 Nov 2022 (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.
To the best of knowledge, only 2 prospective studies, and 1 cross-sectional study have been reported which have seen the periapical healing after non surgical endodontic treatment in diabetic patients and their effect on HbA1c.
Because of the inconsistencies in data available from the literature and considering the limitations of cross-sectional studies, further studies, especially using a prospective design, are required.
So, aim is to investigate the effects of non surgical endodontic treatment on healing and systemic inflammation in individuals with and without diabetes.
Detailed description
Both the systematic review concluded that diabetics have significantly higher prevalence of RFT with RPL. An umbrella review concluded that DM is associated with the outcome of RCT and can be considered as a pre operative prognostic factor.
AP may contribute to low grade systemic inflammation associated with a generalized increase in systemic inflammatory mediators such as C-reactive protein (CRP), interleukin (IL)-1, IL-2, IL-6 and Immunoglobulin (IgA, IgG and IgM) levels .
It is already established that Diabetes mellitus (DM) and periodontitis are highly prevalent non-communicable diseases worldwide and yet they are closely inter-connected with common risk factors and plausibility of increased levels of systemic inflammation. It is evident that periodontitis significantly increases the risk of cardiovascular and renal complications in patients with type 2 diabetes mellitus (T2DM) . Higher serum high-sensitivity C-reactive protein (hsCRP) levels were reported in individuals with AP when compared to healthy controls . Also, there was a positive correlation of increased serum hsCRP levels with increasing severity of AP . A meta-analysis concluded that patients with AP had higher peripheral blood levels of CRP than controls and recommended the need for further studies to evaluate whether the treatment of AP can reduce serum CRP levels . Root canal treatment can reduce systemic inflammation and early endothelial dysfunction.
There is no published prospective interventional study evaluating the effect of root canal treatment on serum hsCRP levels in diabetic patients with AP.
Therefore, the aim of this study is to assess the impact of root canal treatment on HbA1c and serum hsCRP levels in diabetic adults with AP in comparison to healthy patients with AP.
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 |
|---|---|---|
| TYPE 2 DIABETIC PATIENTS | Experimental | Procedure: Nonsurgical root canal therapyNON SURGICAL ROOT CANAL TREATMENT |
| HEALTHY CONTROL GROUP PATIENTS | Experimental | Procedure: Nonsurgical root canal therapyNON SURGICAL ROOT CANAL TREATMENT |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Known patient of type 2 diabetes mellitus with HbA1c ≥6.5 %. Age between 30 to 65 years. Mature permanent posterior tooth having apical periodontitis requiring primary root canal treatment.
- No evidence of systemic diseases other than diabetes being a risk factor for apical periodontitis.
- A radiographic evidence of periapical radiolucency (minimum size,≥2mm x2mm) and a diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests.
- No antibiotic therapy within the preceding one month.
Key exclusion criteria (3 listed)
- Teeth with procedural errors, cracks, fractured teeth. patients with previously endodontically treated teeth with periapical radiolucencies.
- Teeth that were not suitable for rubber dam isolation. smokers, pregnant patients. Patients with moderate and severe periodontitis. Systemic diseases other than diabetes being a risk factor for apical periodontitis.
- Immunocompromised patients.
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 |
|---|---|---|
| Nonsurgical root canal therapyAlso: Root canal treatmentAfter administration of LA and rubber dam isolation, acess cavity will be prepared using carbide burs in high speed hand piece with copious irrigation. Working length will be determined using root ZX apex locator and will be verified radiographically. Canal preparation will be done with protaper rotary instruments in which Sx to S2 will be used to shape the canals and F1 and F2 will be used to finish until the apex. 5ml of 5.25% NaOCl will be used as irrigant after each instrument. After instrumentation , the canals will be irrigated with 5.0 ml of 17% EDTA for 1minute followed by irrigation with 5.0 ml of 5.25% NaOCl. Canals will be dried with absorbent paper points, filled with calcium hydroxide paste and access cavity will be restored with IRM. Patients will be recalled after 1 week.At the next appointment, after paste removal, copious irrigation with 5.25% NaOCl will be done and canals will be dried with paper points. Canals will be obturated with Gutta-Percha and ZOE based sealer. | Procedure or surgery | HEALTHY CONTROL GROUP PATIENTS, TYPE 2 DIABETIC PATIENTS |
Primary outcome
Glycemic index (HbA1c) levels
Time frame: Baseline to one year
A hemoglobin A1C (HbA1C) test is a blood test that shows what your average blood sugar (glucose) level was over the past two to three months. A normal HbA1C level is below 5.7%, a level of 5.7% to 6.4% indicates prediabetes, and a level of 6.5% or more indicates diabetes
high sensitivity C- reactive protein- hsCRP.
Time frame: Baseline to one year
High-sensitivity C-reactive protein (hsCRP) (unit- mg/L)is a marker of inflammation that predicts incident myocardial infarction, stroke, peripheral arterial disease, and sudden cardiac death among healthy individuals with no history of cardiovascular disease, and recurrent events and death in patients with acute or stable coronary syndromes. hsCRP confers additional prognostic value at all levels of cholesterol, Framingham coronary risk score, severity of the metabolic syndrome, and blood pressure, and in those with and without subclinical atherosclerosis. hsCRP levels of less than 1, 1 to 3, and greater than 3 mg/L are associated with lower, moderate, and higher cardiovascular risks, respectively.
1 secondary outcome
Clinical and Radiographic success
Time frame: Baseline to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for PERIAPICAL LESIONS
Active, not recruiting
Early Healing of Apical Periodontitis After Root Canal Treatment With Bioceramic and Calcium Hydroxide Medicaments: Evaluation Using PAI and ImageJ
Apical Periodontitis, Root Canal Treatment
Not yet recruitingObservational study
Diagnostic Performance of Ai vs Junior Dentists
Diagnosis
Active, not recruitingObservational study
A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
Periapical Periodontitis, Periapical Abscess
Active, not recruiting
Effect of Apical Patency on Periapical Lesion Healing
Periapical Lesion, Apical Periodontitis
Recruiting
The Effect of Different Intracanal Medicaments on Periapical Lesion Healing
Periapical Lesion Healing, Apical Periodontitis
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nonsurgical root canal therapy in people with PERIAPICAL LESIONS, run by Postgraduate Institute of Dental Sciences Rohtak at 2 sites 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 3 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 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Glycemic index (HbA1c) levels (time frame: Baseline to one year). The study lists 2 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 16 Nov 2022.