Effect of Smoking on Periapical Healing After NSRCT
April 4, 2023 updated by: Sanjay Tewari, Postgraduate Institute of Dental Sciences Rohtak
To Evaluate the Effect of Smoking on Periapical Healing After Non Surgical Root Canal Treatment- a Prospective Cohort Study
Goal of this prospective observational study is determine effect of smoking on periapical healing after NSRCT.
Population includes systemically healthy smokers with radiographic evidence of apical periodontitis will be recruited and compared with same type of population of non smokers after non surgical root canal treatment intervention in both the groups.
Outcome will be assessed using periapical index scoring system at 6 and 12 months follow up period
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The clinical and radiological success of primary non-surgical endodontic treatment in smoker & nonsmoker patients will be compared between both groups and smoking cessation effect on periapical healing will be assessed.
The correlation between the self-reported smoking status & smoking status by urine analysis
Study Type
Observational
Enrollment (Actual)
116
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Haryana
-
Rohtak, Haryana, India, 124001
- PGIDS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Smokers of age 18 years (male/female) and above having apical periodontitis with age and gender matched controls will be enrolled in the study.
Description
Inclusion Criteria:
- systemically healthy patients of age 18 years and above, known current smoker patient , a non-smoker or former smoker patient ,should have at least minimum 8 teeth in oral cavity, requiring periapical radiographs of teeth with periapical pathosis
Exclusion Criteria:
- Pregnant or patient having systemic disorders, those patients who are non-compliant and not maintaining oral hygiene, teeth requiring retreatment and having procedural errors. Teeth that are not suitable for rubber dam isolation, teeth that have advanced periodontal disease and having endo-perio lesions and, patients requiring endocarditis prophylaxis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group-A Smokers
smoker patients will be recruited in this group
|
After administration of LA and rubber dam isolation, access 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 rotary instruments .
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.
|
|
Group-B Non-Smokers
non smokers or patients who had quit smoking will be recruited in this group
|
After administration of LA and rubber dam isolation, access 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 rotary instruments .
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiographic healing
Time Frame: 12 months
|
Radiographic healing measured by change in ize of apical radiolucency assessed by Periodical index (PAI) . PAI score 1 and 2 are classified as healed and PAI score 3,4,and 5 as unhealed. |
12 months
|
|
Clinical Success
Time Frame: 12 month
|
Absence of clinical signs and symptoms such as spontaneous pain, presence of sinus tract, swelling, mobility, or sensitivity to percussion or palpation
|
12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Dr. Sanjay Tewari, MDS, Post Graduate Institute Of Dental Sciences,Rohtak
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Actual)
January 31, 2022
Study Completion (Actual)
March 1, 2023
Study Registration Dates
First Submitted
December 11, 2021
First Submitted That Met QC Criteria
April 4, 2023
First Posted (Actual)
April 5, 2023
Study Record Updates
Last Update Posted (Actual)
April 5, 2023
Last Update Submitted That Met QC Criteria
April 4, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PGIDS/BHRC/21/35
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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