Effect of Smoking on Periapical Healing After NSRCT

Apical Periodontitis Clinical Trial

Official title:

To Evaluate the Effect of Smoking on Periapical Healing After Non Surgical Root Canal Treatment- a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05799937
• Other study ID #: PGIDS/BHRC/21/35
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: April 2023
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: March 1, 2023
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apical Periodontitis
• Periapical Periodontitis
• Periodontitis

Intervention

Procedure:
• Non Surgical Root Canal Treatment
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.

Locations

Country	Name	City	State
India	PGIDS	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic healing	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
Primary	Clinical Success	Absence of clinical signs and symptoms such as spontaneous pain, presence of sinus tract, swelling, mobility, or sensitivity to percussion or palpation	12 month