Apical PeriodontitisNCT05799937
Effect of Smoking on Periapical Healing After NSRCT
An observational study of Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Non Surgical Root Canal Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 116 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2021to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Apical Periodontitis
- Being tested
- Non Surgical Root Canal Treatment
- Keywords
- apical periodontitis, periapical pathology, smokers, non-smokers
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Surgical Root Canal TreatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group-A Smokers | smoker patients will be recruited in this group Receives: Procedure: Non Surgical Root Canal Treatment | |
| Group-B Non-Smokers | non smokers or patients who had quit smoking will be recruited in this group Receives: Procedure: Non Surgical Root Canal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Jul 2021
- Primary completion31 Jan 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjay Tewari, Postgraduate Institute of Dental Sciences Rohtak
- Investigators
- Dr. Sanjay Tewari, MDS, Study director, Post Graduate Institute Of Dental Sciences,Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799937
- Sponsor's protocol ID
- PGIDS/BHRC/21/35
- Status last verified
- Apr 2023
- First submitted
- 11 Dec 2021
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Effect of Smoking on Periapical Healing After Non Surgical Root Canal Treatment- a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05799937
- Acronym / sponsor ID
- PGIDS/BHRC/21/35
- Conditions
- Apical Periodontitis
- Keywords
- apical periodontitis, periapical pathology, smokers, non-smokers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-A Smokers | – | Procedure: Non Surgical Root Canal Treatmentsmoker patients will be recruited in this group |
| Group-B Non-Smokers | – | Procedure: Non Surgical Root Canal Treatmentnon smokers or patients who had quit smoking will be recruited in this group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Surgical Root Canal TreatmentAfter 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. | Procedure or surgery | Group-A Smokers, Group-B Non-Smokers |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Sanjay Tewari, MDS study director
Post Graduate Institute Of Dental Sciences,Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic healing (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.