Effect of Smoking on Periapical Healing After NSRCT

NCT05799937 | Completed DMC

• 1 other identifier: PGIDS/BHRC/21/35
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Apical Periodontitis

Keywords

apical periodontitis, periapical pathology, smokers, non-smokers

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Group-A Smokers

smoker patients will be recruited in this group

Procedure: Non Surgical Root Canal Treatment

Group-B Non-Smokers

non smokers or patients who had quit smoking will be recruited in this group

Procedure: Non Surgical Root Canal Treatment

Interventions

Non Surgical Root Canal Treatment PROCEDURE

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-A Smokers; Group-B Non-Smokers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine analysis

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Dr. Sanjay Tewari, MDS

  Post Graduate Institute Of Dental Sciences,Rohtak

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal

Study Record Dates

• First Submitted: December 11, 2021
• First Posted: April 5, 2023
• Study Start: July 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: March 1, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

IN (1)