Association of Apical Periodontitis With Systemic Level of Inflammatory Markers : A Longitudinal Intervention Study
NCT ID: NCT05814965
Last Updated: 2023-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
280 participants
INTERVENTIONAL
2023-04-05
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Serum Pro-Diabetes Inflammation Biomarkers in Patients With Apical Periodontitis.
NCT04824209
Biomarkers of Periodontal Disease Progression
NCT01489839
Inflammation-Related Endothelial Barrier Dysfunction in Patients With Apical Periodontitis
NCT07292363
Association of Apical Periodontitis With Hs-CRP and Hemogram Indices
NCT04980768
Type I Diabetes and Non-surgical Periodontal Treatment
NCT05569525
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Diabetic patients with Apical periodontitis
Diabetic patients with Apical periodontitis received Endodontics treatment in form of Root canal treatment and assessment of inflammatory and metabolic markers
endodontic treatment in the form of root canal treatment
Patients will receive endodontic treatment, and inflammatory markers will be assessed
Healthy patients with Apical periodontitis
systemically healthy participants patients with Apical periodontitis received Endodontics treatment in the form of root canal treatment and assessment of inflammatory markers
endodontic treatment
Patients will receive endodontic treatment in the form of root canal treatment, and inflammatory markers will be assessed along with metabolic markers assessment
Diabetic patients with out Apical periodontitis
systemic inflammatory markers along with metabolic markers will be assessed
inflammatory markers will be assessed along with metabolic markers assessment
inflammatory markers will be assessed along with metabolic markers assessment
Healthy participants without Apical periodontitis
systemic inflammatory markers will be assessed
assessment of inflammatory marker
assessment of inflammatory markers
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
endodontic treatment in the form of root canal treatment
Patients will receive endodontic treatment, and inflammatory markers will be assessed
endodontic treatment
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 marker
assessment of inflammatory markers
inflammatory markers will be assessed along with metabolic markers assessment
inflammatory markers will be assessed along with metabolic markers assessment
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
30 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Postgraduate Institute of Dental Sciences Rohtak
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
SANJAY TEWARI
Role: PRINCIPAL_INVESTIGATOR
POST GRADUATE INSTITUTE OF DENTAL SCIENCES,ROHTAK
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
PGIDS
Rohtak, Haryana, India
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Dr. Sanjay Tewari 2023
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.