Diabete Type 2NCT05170880
Effect of Primary Non-surgical Endodontic Therapy on Glycaemic Control in Type 2 Diabetic Patients With Asymptomatic Apical Periodontitis
A study testing Primary endodontic treatment in people with Diabete Type 2 and Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
To evaluate the effect of primary non-surgical endodontic therapy on glycaemic control in type 2 diabetic patients with asymptomatic apical periodontitis.After fulfilling the eligibility criteria, patients will be informed about the study and written consent to participate in the study will be acquired from each… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabete Type 2, Apical Periodontitis
- What is being tested?
- Primary endodontic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 11 Feb 2019to 30 Aug 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient willing to participate in the study. Patients with a history of type 2 DM (with HbA1c ≥ 6.5%), between the age of 30 to 65 years, asymptomatic mature permanent teeth with pulpal necrosis as confirmed by a negative response to cold and electric test and radiographic evidence of AP no history of systemic antibiotic administration within the last 1 month;
Who cannot join
- Symptomatic patients Retreatment Unwillingness of patients Procedural errors and calcified canals ,inability to achieve apical patency in any canals Immuno-compromised, pt. on long term steroids, pregnant and patient with any other systemic illness except diabetes mellitus.
- Teeth with periodontal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Primary Non-surgical Endodontic Therapy on Glycaemic Control in Type 2 Diabetic Patients With Asymptomatic Apical Periodontitis: A Randomized Controlled Trial
To evaluate the effect of primary non-surgical endodontic therapy on glycaemic control in type 2 diabetic patients with asymptomatic apical periodontitis.After fulfilling the eligibility criteria, patients will be informed about the study and written consent to participate in the study will be acquired from each patient after explaining risks, benefits and alternative treatments.The endodontic treatment for all patients will be performed by a single operator (S.A) following a standardized protocol. The control group will receive no endodontic treatment during the study period. After completion of the study, these patients will be given primary non-surgical endodontic treatment. The patients in control group will be rendered the necessary treatment, if they become symptomatic and/or deny the consent during the course of the study. These patients will be excluded from the study.
Read the detailed description
INTRODUCTION:
Diabetes mellitus (DM) is a clinically and genetically heterogeneous group of disorders affecting the metabolism of carbohydrate, lipid or proteins, in which hyperglycemia is the main feature. These disorders are either due to insulin deficiency related to autoimmune destruction of pancreatic beta cells (type 1) or target tissue resistance to its cellular metabolic effects (type 2).1 Patients suffering from DM are known to have increased susceptibility to infections2.Evidence has consistently indicated that DM is a risk factor for increased severity of periodontal disease3,4.
Apical Periodontitis (AP) is an acute or chronic inflammation of the periodontium located at the root apex caused by bacterial infection of the pulp canal system5.
Traditionally, DM is diagnosed by either fasting or postprandial blood glucose but since 2010 American Diabetes Association (ADA) has recommended mean HbA1c as diagnostic criteria of diabetes with its threshold level of 6.5%. HbA1c is a resulting product of hemoglobin and glucose interaction and its elevated level indirectly reflects the hyperglycemic condition i.e. DM. Studies have been conducted linking periodontal disease and diabetes mellitus in terms of prevalence and worsening of glycemic control in diabetics as well as effect of periodontal treatment on glycemic control in diabetic patients. Nevarro-Sanchez et al showed significant improvement in HbA1c levels after non surgical periodontal therapy in diabetic patients .
The aim of the present trial is to evaluate the effect of endodontic therapy on glycemic status in patients with apical periodontitis.
AIM AND OBJECTIVES:
To evaluate the effect of primary non-surgical endodontic therapy on glycaemic control in type 2 diabetic patients with asymptomatic apical periodontitis.
MATERIALS AND METHODOLOGY:
This study will be conducted in the department of conservative dentistry and endodontics, Post Graduate Institute of Dental Sciences (PGIDS), Rohtak. Study subjects will be obtained from the pool of OPD patients in the Department of conservative dentistry and endodontics, PGIDS, Rohtak.
Study Design: Intervention Study period: December Study subjects: 30
Baseline parameters -- Endodontic evaluation - Pulp sensibility testing will be performed with a combination of heat test, cold test and electric pulp test. Teeth not responding to both thermal and electric test will be considered non vital.
Radiographic evaluation - Radiographs with paralleling cone technique at baseline and at subsequent appointment (3 months) will be taken at standardized exposure parameters.
Glycemic Control Assessment To determine the metabolic control status of diabetic patients, HbA1c will be registered on the day of treatment initiation. For the metabolic assessment, venous blood samples will be taken from each patient and analysed for glycated haemoglobin (HbA1c). Metabolic measurements will be performed at baseline and at 3rd month following the endodontic treatment in the treatment and control group.
Randomization: Patients will be randomly allocated by envelope method into two groups- intervention group (IG) , Group II= Control group (CG). The opaque envelopes will be prepared by an independent observer blinded to the treatment groups. The patients will be asked to choose an envelope at the time of recruitment which will decide the group into which patient will be allocated.
Methodology:
After fulfilling the eligibility criteria, patients will be informed about the study and written consent to participate in the study will be acquired from each patient after explaining risks, benefits and alternative treatments. Prior to treatment a thorough clinical and radiological examination will be carried out and thorough history will be taken from each patient. Patients will be instructed to continue with their medical treatment of DM (oral hypoglycemic agents), diet and life style without modifications during the study period.
Clinical Procedure:
The endodontic treatment for all patients will be performed by a single operator (S.A) following a standardized protocol. After local anesthesia administration (2 % xylocaine with 1:80000 epinephrine), access cavity will be prepared using under rubber dam isolation. After pulp chamber debridement and canal orifices identification, coronal shaping \& enlargement will be performed with low speed gates-glidden drills to obtain straight line access to the apical third of each root canal. Working length will be determined with the help of Root ZX apex locator and verified radiographically. Canals will be prepared using the crown down technique with rotary instruments. Canals will be irrigated with 5 ml of 5.25 % sodium hypochlorite (NaOCl) subsequent to change of each instrument. After complete canal instrumentation, the canals will be irrigated with 5.0 ml of 17% ethylene-diaminetetra acetic acid for 1 minute followed by a final irrigation with 5.0 ml of 5.25% NaOCl. Canals will be filled with a paste of calcium hydroxide and access will be sealed temporarily with Intermediate Restorative Material. Patient will be scheduled for second visit after one week. At the next appointment, the paste will be removed with Hedstrom files followed by copious irrigation with 5.25% NaOCl. Canals will be obturated using lateral condensation technique. After obturation, the cavity will be permanently restored. Immediate post-operative radiograph will be taken using preset exposure parameters with a Rinn paralleling device.
The control group will receive no endodontic treatment during the study period. After completion of the study, these patients will be given primary non-surgical endodontic treatment. The patients in control group will be rendered the necessary treatment, if they become symptomatic and/or deny the consent during the course of the study. These patients will be excluded from the study.
Post - Operative Follow-Up:
Patients will be evaluated after 3 months. Radiograhic evaluation: periapical radiographs will be taken to observe the healing.
Metabolic evaluation: For the metabolic assessment patients will be analysed for glycated haemoglobin (HbA1c).
Clinical evaluation: Patients will be evaluated for the presence of any abnormal clinical findings.
Statistical analysis Shapiro Wilk test will be used to analyze the distribution of data. Categorical data will be analyzed by chi square test. Regression analysis will be done to observe any association between independent and dependent variables. Interobserver/intraobserver reliability will be analyzed with Cohen kappa analysis
- Conditions
- Diabete Type 2, Apical Periodontitis
- Being tested
- Primary endodontic treatment
- Keywords
- Type 2 Diabetes Mellitus, Apical Periodontitis
- Medical subject headings
- Diabetes Mellitus, Type 2, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary endodontic treatmentProcedure or surgery
Primary non surgical endodontic treatment will be provided to patients in treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | After fulfilling the eligibility criteria, patients will be informed about the study and written consent to participate in the study will be acquired from each patient after explaining risks, benefits and alternative treatments.The endodontic treatment for all patients will be performed by a single operator (S.A) following a standardized protocol. Receives: Procedure: Primary endodontic treatment |
| Control Group | No intervention | The control group will receive no endodontic treatment during the study period. After completion of the study, these patients will be given primary non-surgical endodontic treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c levels
Glycemic status will be evaluated using HbA1c levels.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start11 Feb 2019
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170880
- Sponsor's protocol ID
- Dr. Aparna
- Status last verified
- Jan 2019
- First submitted
- 11 Dec 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Primary Non-surgical Endodontic Therapy on Glycaemic Control in Type 2 Diabetic Patients With Asymptomatic Apical Periodontitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05170880
- Acronym / sponsor ID
- Dr. Aparna
- Conditions
- Diabete Type 2, Apical Periodontitis
- Keywords
- Type 2 Diabetes Mellitus, Apical Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 28 Dec 2021 (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 evaluate the effect of primary non-surgical endodontic therapy on glycaemic control in type 2 diabetic patients with asymptomatic apical periodontitis.After fulfilling the eligibility criteria, patients will be informed about the study and written consent to participate in the study will be acquired from each patient after explaining risks, benefits and alternative treatments.The endodontic treatment for all patients will be performed by a single operator (S.A) following a standardized protocol. The control group will receive no endodontic treatment during the study period. After completion of the study, these patients will be given primary non-surgical endodontic treatment. The patients in control group will be rendered the necessary treatment, if they become symptomatic and/or deny the consent during the course of the study. These patients will be excluded from the study.
Detailed description
INTRODUCTION:
Diabetes mellitus (DM) is a clinically and genetically heterogeneous group of disorders affecting the metabolism of carbohydrate, lipid or proteins, in which hyperglycemia is the main feature. These disorders are either due to insulin deficiency related to autoimmune destruction of pancreatic beta cells (type 1) or target tissue resistance to its cellular metabolic effects (type 2).1 Patients suffering from DM are known to have increased susceptibility to infections2.Evidence has consistently indicated that DM is a risk factor for increased severity of periodontal disease3,4.
Apical Periodontitis (AP) is an acute or chronic inflammation of the periodontium located at the root apex caused by bacterial infection of the pulp canal system5.
Traditionally, DM is diagnosed by either fasting or postprandial blood glucose but since 2010 American Diabetes Association (ADA) has recommended mean HbA1c as diagnostic criteria of diabetes with its threshold level of 6.5%. HbA1c is a resulting product of hemoglobin and glucose interaction and its elevated level indirectly reflects the hyperglycemic condition i.e. DM. Studies have been conducted linking periodontal disease and diabetes mellitus in terms of prevalence and worsening of glycemic control in diabetics as well as effect of periodontal treatment on glycemic control in diabetic patients. Nevarro-Sanchez et al showed significant improvement in HbA1c levels after non surgical periodontal therapy in diabetic patients .
The aim of the present trial is to evaluate the effect of endodontic therapy on glycemic status in patients with apical periodontitis.
AIM AND OBJECTIVES:
To evaluate the effect of primary non-surgical endodontic therapy on glycaemic control in type 2 diabetic patients with asymptomatic apical periodontitis.
MATERIALS AND METHODOLOGY:
This study will be conducted in the department of conservative dentistry and endodontics, Post Graduate Institute of Dental Sciences (PGIDS), Rohtak. Study subjects will be obtained from the pool of OPD patients in the Department of conservative dentistry and endodontics, PGIDS, Rohtak.
Study Design: Intervention Study period: December Study subjects: 30
Baseline parameters -- Endodontic evaluation - Pulp sensibility testing will be performed with a combination of heat test, cold test and electric pulp test. Teeth not responding to both thermal and electric test will be considered non vital.
Radiographic evaluation - Radiographs with paralleling cone technique at baseline and at subsequent appointment (3 months) will be taken at standardized exposure parameters.
Glycemic Control Assessment To determine the metabolic control status of diabetic patients, HbA1c will be registered on the day of treatment initiation. For the metabolic assessment, venous blood samples will be taken from each patient and analysed for glycated haemoglobin (HbA1c). Metabolic measurements will be performed at baseline and at 3rd month following the endodontic treatment in the treatment and control group.
Randomization: Patients will be randomly allocated by envelope method into two groups- intervention group (IG) , Group II= Control group (CG). The opaque envelopes will be prepared by an independent observer blinded to the treatment groups. The patients will be asked to choose an envelope at the time of recruitment which will decide the group into which patient will be allocated.
Methodology:
After fulfilling the eligibility criteria, patients will be informed about the study and written consent to participate in the study will be acquired from each patient after explaining risks, benefits and alternative treatments. Prior to treatment a thorough clinical and radiological examination will be carried out and thorough history will be taken from each patient. Patients will be instructed to continue with their medical treatment of DM (oral hypoglycemic agents), diet and life style without modifications during the study period.
Clinical Procedure:
The endodontic treatment for all patients will be performed by a single operator (S.A) following a standardized protocol. After local anesthesia administration (2 % xylocaine with 1:80000 epinephrine), access cavity will be prepared using under rubber dam isolation. After pulp chamber debridement and canal orifices identification, coronal shaping \& enlargement will be performed with low speed gates-glidden drills to obtain straight line access to the apical third of each root canal. Working length will be determined with the help of Root ZX apex locator and verified radiographically. Canals will be prepared using the crown down technique with rotary instruments. Canals will be irrigated with 5 ml of 5.25 % sodium hypochlorite (NaOCl) subsequent to change of each instrument. After complete canal instrumentation, the canals will be irrigated with 5.0 ml of 17% ethylene-diaminetetra acetic acid for 1 minute followed by a final irrigation with 5.0 ml of 5.25% NaOCl. Canals will be filled with a paste of calcium hydroxide and access will be sealed temporarily with Intermediate Restorative Material. Patient will be scheduled for second visit after one week. At the next appointment, the paste will be removed with Hedstrom files followed by copious irrigation with 5.25% NaOCl. Canals will be obturated using lateral condensation technique. After obturation, the cavity will be permanently restored. Immediate post-operative radiograph will be taken using preset exposure parameters with a Rinn paralleling device.
The control group will receive no endodontic treatment during the study period. After completion of the study, these patients will be given primary non-surgical endodontic treatment. The patients in control group will be rendered the necessary treatment, if they become symptomatic and/or deny the consent during the course of the study. These patients will be excluded from the study.
Post - Operative Follow-Up:
Patients will be evaluated after 3 months. Radiograhic evaluation: periapical radiographs will be taken to observe the healing.
Metabolic evaluation: For the metabolic assessment patients will be analysed for glycated haemoglobin (HbA1c).
Clinical evaluation: Patients will be evaluated for the presence of any abnormal clinical findings.
Statistical analysis Shapiro Wilk test will be used to analyze the distribution of data. Categorical data will be analyzed by chi square test. Regression analysis will be done to observe any association between independent and dependent variables. Interobserver/intraobserver reliability will be analyzed with Cohen kappa analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Procedure: Primary endodontic treatmentAfter fulfilling the eligibility criteria, patients will be informed about the study and written consent to participate in the study will be acquired from each patient after explaining risks, benefits and alternative treatments.The endodontic treatment for all patients will be performed by a single operator (S.A) following a standardized protocol. |
| Control Group | No intervention | –The control group will receive no endodontic treatment during the study period. After completion of the study, these patients will be given primary non-surgical endodontic treatment. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient willing to participate in the study. Patients with a history of type 2 DM (with HbA1c ≥ 6.5%), between the age of 30 to 65 years, asymptomatic mature permanent teeth with pulpal necrosis as confirmed by a negative response to cold and electric test and radiographic evidence of AP no history of systemic antibiotic administration within the last 1 month;
Key exclusion criteria (2 listed)
- Symptomatic patients Retreatment Unwillingness of patients Procedural errors and calcified canals ,inability to achieve apical patency in any canals Immuno-compromised, pt. on long term steroids, pregnant and patient with any other systemic illness except diabetes mellitus.
- Teeth with periodontal disease.
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 |
|---|---|---|
| Primary endodontic treatmentPrimary non surgical endodontic treatment will be provided to patients in treatment group. | Procedure or surgery | Treatment Group |
Primary outcome
HbA1c levels
Time frame: 3 months
Glycemic status will be evaluated using HbA1c levels.
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 28 Dec 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary endodontic treatment in people with Diabete 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 1 inclusion and 2 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 28 Dec 2021. 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?
HbA1c levels (time frame: 3 months). 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 28 Dec 2021.