Apical PeriodontitisNCT04390789
Single And Multiple-visit Endodontic Retreatment Outcome.
A study testing Non surgical Single visit Retreatment and Multi visit Retreatment with calcium hydroxide dressing in people with Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 2 sites in India.
Trial summary
This study will compare the outcome of single visit retreatment and multi-visit retreatment in cases of failed root canal treated teeth. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Non surgical Single visit Retreatment and Multi visit Retreatment with calcium hydroxide dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesIndia
- Study dates
- 15 Dec 2019to 15 Jun 2021
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient willingness to participate in the study.
- Previously root filled Permanent teeth with post-treatment apical periodontitis requiring nonsurgical root canal retreatment.
- Failure of previous root canal treatment will be determined based on clinical and radiographic findings. Clinical indicators of failure will include pain, tenderness to palpation/percussion, swelling, sinus tract.Radiographic criteria will include persistent periapical radiolucent lesions in teeth in which initial treatments were performed at least 4 years previously.
- Root canal fillings no more than 4mm short of the apex.
- Patients showing no significant systemic disease
Who cannot join
- Patients who are pregnant, diabetic, immunocompromised, serious medical illness or requiring antibiotic premedication.
- Patient under 18 years of age.
- Patient under corticosteroid use.
- Patients with history of antibiotic use in last 3 months or analgesic use in last one week will also be excluded.
- Multiple teeth that require treatment to eliminate the possibility of pain referral.Patients with unrestorable carious lesions, fractures involving the periodontium, and/or periodontal pockets ≥ 4mm deep or having marginal or furcal bone loss due to periodontitis .
- Teeth with the procedural errors preventing access to apical third and missed canals will be excluded.
- Teeth that are not suitable for rubber dam isolation.
- Teeth with intraradicular post.
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Recruiting
Post graduate institute of dental sciences
Rohtak, Haryana, 124001
Sanjay Tewari, MDS, 01262283876, principalpgids@yahoo.in
- Recruiting
Sanjay Tewari
Rohtak, Haryana, 124001
Sanjay TEWARI, 9416259534, principalpgids@yahoo.in
About this study
Official title: Outcome Following Single-visit And Multiple-visit Nonsurgical Endodontic Retreatment
This study will compare the outcome of single visit retreatment and multi-visit retreatment in cases of failed root canal treated teeth.
Read the detailed description
Retreatment is defined as a procedure to remove root canal filling materials from the tooth, followed by cleaning, shaping and obturating the canals.Although initial root canal therapy has been shown to be a predictable procedure with a high degree of success, failures can occur after treatment. Recent publications have reported failure rates of 14%-16% for initial root canal treatment. In order to prevent tooth loss in such cases, nonsurgical retreatment or apical surgery is often indicated.
In this study subjects will be assigned to either the single-visit and multi-visit nonsurgical endodontic retreatment. The allocation will be performed once the chemomechanical preparation is completed.
Clinical and radiographic success rate will be considered as primary outcome. Follow up will be carried out every 3 months, till 12-month period.
Pain intensity will be considered as secondary outcome.
- Conditions
- Apical Periodontitis
- Being tested
- Non surgical Single visit Retreatment, Multi visit Retreatment with calcium hydroxide dressing
- Keywords
- Nonsurgical Retreatment, Single Visit, Multi visit, Calcium Hydroxide, Outcome
- 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 Single visit RetreatmentProcedure or surgery
Non-surgical endodontic retreatment will be carried out in single visit.
Multi visit Retreatment with calcium hydroxide dressingProcedure or surgery
In this group,GP removal and biomechanical preparation will be carried out in first visit,after which calcium hydroxide dressing will be placed and temporarily restored.after 7 days,in second visit obturation will be done followed by permanent restoration
| Study group | Role | What they receive |
|---|---|---|
| single visit retreatment | Experimental | nonsurgical root canal retreatment will be carried out in single visit. Receives: Procedure: Non surgical Single visit Retreatment |
| multi visit retreatment | Active comparator | In this group,GP removal and biomechanical preparation will be carried out in first visit,after which calcium hydroxide dressing will be placed and temporarily restored.after 7 days,in second visit obturation will be done followed by permanent restoration Receives: Procedure: Multi visit Retreatment with calcium hydroxide dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiographic success
Criteria of clinical success:
Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility of grade-I or less, and no deterioration in periodontal probing depth as compared with baseline measurements
Criteria of radiographic Success:
PAI score 1-Normal periapical structures, OR PAI Score 2-Small changes in bone structure.
Criteria of radiographic Failure:
PAI score 3-Changes in bone structure with some mineral loss, OR PAI Score 4-Apical periodontitis with well-defined radiolucent area, OR PAI Score 5-Severe periodontitis with exacerbating features
Measured: Baseline to 1 year
Secondary outcomes (1)
Pain assessment
Visual analogue scale (VAS) from 0 to 10 will be used to record preoperative and post -operative pain.
Measured: Baseline to 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start15 Dec 2019
- Primary completion15 Jun 2020 (estimated)
- Study completion15 Jun 2021 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kajal Bhayani, Principal investigator, POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390789
- Sponsor's protocol ID
- Kajal Bhayani
- Status last verified
- Dec 2019
- First submitted
- 13 May 2020
- Last updated
- 18 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Following Single-visit And Multiple-visit Nonsurgical Endodontic Retreatment
- ClinicalTrials.gov ID
- NCT04390789
- Acronym / sponsor ID
- Kajal Bhayani
- Conditions
- Apical Periodontitis
- Keywords
- Nonsurgical Retreatment, Single Visit, Multi visit, Calcium Hydroxide, Outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 18 May 2020 (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.
This study will compare the outcome of single visit retreatment and multi-visit retreatment in cases of failed root canal treated teeth.
Detailed description
Retreatment is defined as a procedure to remove root canal filling materials from the tooth, followed by cleaning, shaping and obturating the canals.Although initial root canal therapy has been shown to be a predictable procedure with a high degree of success, failures can occur after treatment. Recent publications have reported failure rates of 14%-16% for initial root canal treatment. In order to prevent tooth loss in such cases, nonsurgical retreatment or apical surgery is often indicated.
In this study subjects will be assigned to either the single-visit and multi-visit nonsurgical endodontic retreatment. The allocation will be performed once the chemomechanical preparation is completed.
Clinical and radiographic success rate will be considered as primary outcome. Follow up will be carried out every 3 months, till 12-month period.
Pain intensity will be considered as secondary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single visit retreatment | Experimental | Procedure: Non surgical Single visit Retreatmentnonsurgical root canal retreatment will be carried out in single visit. |
| multi visit retreatment | Active comparator | Procedure: Multi visit Retreatment with calcium hydroxide dressingIn this group,GP removal and biomechanical preparation will be carried out in first visit,after which calcium hydroxide dressing will be placed and temporarily restored.after 7 days,in second visit obturation will be done followed by permanent restoration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient willingness to participate in the study.
- Previously root filled Permanent teeth with post-treatment apical periodontitis requiring nonsurgical root canal retreatment.
- Failure of previous root canal treatment will be determined based on clinical and radiographic findings. Clinical indicators of failure will include pain, tenderness to palpation/percussion, swelling, sinus tract.Radiographic criteria will include persistent periapical radiolucent lesions in teeth in which initial treatments were performed at least 4 years previously.
- Root canal fillings no more than 4mm short of the apex.
- Patients showing no significant systemic disease
Key exclusion criteria (8 listed)
- Patients who are pregnant, diabetic, immunocompromised, serious medical illness or requiring antibiotic premedication.
- Patient under 18 years of age.
- Patient under corticosteroid use.
- Patients with history of antibiotic use in last 3 months or analgesic use in last one week will also be excluded.
- Multiple teeth that require treatment to eliminate the possibility of pain referral.Patients with unrestorable carious lesions, fractures involving the periodontium, and/or periodontal pockets ≥ 4mm deep or having marginal or furcal bone loss due to periodontitis .
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 Single visit RetreatmentNon-surgical endodontic retreatment will be carried out in single visit. | Procedure or surgery | single visit retreatment |
| Multi visit Retreatment with calcium hydroxide dressingIn this group,GP removal and biomechanical preparation will be carried out in first visit,after which calcium hydroxide dressing will be placed and temporarily restored.after 7 days,in second visit obturation will be done followed by permanent restoration | Procedure or surgery | multi visit retreatment |
Primary outcome
Clinical and radiographic success
Time frame: Baseline to 1 year
Criteria of clinical success: Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility of grade-I or less, and no deterioration in periodontal probing depth as compared with baseline measurements Criteria of radiographic Success: PAI score 1-Normal periapical structures, OR PAI Score 2-Small changes in bone structure. Criteria of radiographic Failure: PAI score 3-Changes in bone structure with some mineral loss, OR PAI Score 4-Apical periodontitis with well-defined radiolucent area, OR PAI Score 5-Severe periodontitis with exacerbating features
1 secondary outcome
Pain assessment
Time frame: Baseline to 7days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Individual participant dataSharing planned: No
Related trials for Apical Periodontitis
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Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
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Effect of Different Apical Motion Algorithms on Postoperative Pain After Root Canal Treatment
Apical Periodontitis, Postoperative Pain After Endodontic Treatment
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Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment
Asymptomatic Apical Periodontitis, Endodontic Retreatment
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Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
Not yet recruiting
Comparison of Postoperative Pain After Root Canal Treatment Using Hand-Held vs Rotary ProTaper Files: A Randomized Controlled Trial
Symptomatic Irreversible Pulpitis (SIP), Symptomatic Apical Periodontitis
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.
Kajal Bhayani principal investigator
POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non surgical Single visit Retreatment and Multi visit Retreatment with calcium hydroxide dressing in people with Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 2 sites 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kajal Bhayani (7507962278, bhayanikajal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and radiographic success (time frame: Baseline to 1 year). 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 18 May 2020.