Effect of Smoking on Periapical Healing After NSRCT

NCT ID: NCT05799937

Last Updated: 2023-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-03-01

Brief Summary

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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

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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

Conditions

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Apical Periodontitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group-A Smokers

smoker patients will be recruited in this group

Non Surgical Root Canal Treatment

Intervention Type 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-B Non-Smokers

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

Non Surgical Root Canal Treatment

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Sanjay Tewari

Principal

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Sanjay Tewari, MDS

Role: STUDY_DIRECTOR

Post Graduate Institute Of Dental Sciences,Rohtak

Locations

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PGIDS

Rohtak, Haryana, India

Site Status

Countries

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India

Other Identifiers

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PGIDS/BHRC/21/35

Identifier Type: -

Identifier Source: org_study_id

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