Effect of Smoking on Periapical Healing After NSRCT

Completed

• Conditions: Apical Periodontitis
• Interventions: Procedure: Non Surgical Root Canal Treatment

• Registration Number: NCT05799937
• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak

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

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 Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-12-11
• Primary Completion: 2022-01-31
• Study Completion: 2023-03-01
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-04
• Last Update Submitted: 2023-04-04
• Study First Posted: 2023-04-05
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group-A Smokers	Non Surgical Root Canal Treatment	smoker patients will be recruited in this group
Group-B Non-Smokers	Non Surgical Root Canal Treatment	non smokers or patients who had quit smoking will be recruited in this group

Primary Outcome Measures

Name	Time	Method
Radiographic healing	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.
Clinical Success	12 month	Absence of clinical signs and symptoms such as spontaneous pain, presence of sinus tract, swelling, mobility, or sensitivity to percussion or palpation

Trial Locations

Locations (1)

PGIDS; 🇮🇳 Rohtak, Haryana, India