NCT04980768

Brief Summary

There is lack of evidence on resolution of signs of systemic inflammatory markers by successful elimination of periapical inflammation by endodontic treatment. Complete blood count (CBC) may have potential to detect various inflammatory conditions but its use for this purpose is sparsely reported. To the best of our knowledge effect of chronic apical periodontitis on various parameters of complete blood count has not been studied.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

July 4, 2021

Last Update Submit

July 19, 2021

Conditions

Keywords

Apical periodontitishsCRProot canal treatmenthemograminflammation

Outcome Measures

Primary Outcomes (2)

  • Level of hs-CRP

    Serum level of hs-CRP will be measured using ELISA in g/dl.

    Baseline-3 months

  • Hemogram indices

    Complete hemogram parameters in percentage will be assessed using automated machine.

    Baseline-3 months

Study Arms (1)

Root canal treatment

OTHER

Root canal treatment will be provided to all the participants with the diagnosis of apical periodontitis.

Procedure: Root canal treatment

Interventions

Patients with apical periodontitis will undergo root canal treatment.

Root canal treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pulpal necrosis in mature mandibular molar as confirmed by negative response to pulp sensibility test (cold and electric pulp test)
  • Radiographic evidence of apical periodontitis in the form of periapical radiolucency
  • Radiographic alveolar bone breakdown not more than one third of root length.

You may not qualify if:

  • Obese (BMI \>30 kg/m2), smoker, pregnant, diabetic, immunocompromised or have any other systemic inflammatory condition.
  • Having a positive history of antibiotic use within the past month or require antibiotic premedication for dental treatment (including infective endocarditis or prosthetic joint prophylaxis).
  • Teeth having previous root fillings, unrestorable teeth, fractured/perforated roots, grade 3 mobility, and history of recent periodontal therapy (within previous 6 months).
  • Teeth with established endodontic-periodontal lesions exhibiting \<2 mm radiopaque bone between the root apex.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periapical PeriodontitisInflammation

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2021

First Posted

July 28, 2021

Study Start

February 1, 2021

Primary Completion

August 1, 2021

Study Completion

November 30, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations