Apical PeriodontitisNCT03397875
Effect of Various Sealers on Healing of Teeth With Apical Periodontitis
A study testing Zinc oxide based sealer, Epoxy resin based sealer and Bioactive silicone based sealer in people with Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
This study will compare the effect of three different sealers on healing of teeth with apical periodontitis after primary root canal treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Zinc oxide based sealer, Epoxy resin based sealer and Bioactive silicone based sealer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2016to Apr 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The inclusion criteria of the study will include:
- Patient willing to participate in the study.
- Age >18 years.
- No history of antibiotic use within the past month or requiring antibiotic premedication
- No history of prior analgesic use during past 24 hrs.
- Mature permanent mandibular molar having apical periodontitis requiring primary root canal treatment.
- There must be a radiographic evidence of periapical radiolucency (minimum size 2mmx2mm) and a diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber
Who cannot join
- Re-treatment
- Unwillingness of patients
- The presence of a difficult canal anatomy (root canals with an extreme curvature ≥30 deg), internal or external resorption and immature teeth.
- Accident or complication during treatment (calcified canals ,inability to achieve apical patency in any canals) Immuno-compromised, diabetic, pregnant and hypertensive patients.
- Teeth that are peridontally compromised
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Various Sealers on Healing of Teeth With Apical Periodontitis: A Clinical Study
This study will compare the effect of three different sealers on healing of teeth with apical periodontitis after primary root canal treatment.
Read the detailed description
Various sealers with different chemical composition and properties are available but it is yet not clear if one sealer is superior to other in terms of healing of apical periodontitis.
Three different groups of sealers will be used- a zinc oxide based sealer, an epoxy resin based sealer and a bioactive silicone based sealer. Mature mandibular permanent molar with the diagnosis of apical periodontitis (as confirmed clinically \& by periapical radiograph) will be chosen for the study. Primary non surgical root canal treatment will be performed. The sealer will be randomly selected just before obturation of root canals. The patient will be allotted to one of the three groups.
- Group I: Zinc oxide eugenol sealer group. The material will be mixed according to manufacturer instructions and applied to canals using a lentulospiral and the obturation will be performed.
- Group II: Epoxy resin based sealer group. The material will be mixed according to the manufacturer's instructions and obturation will be done.
- Group III: Bioactive silicone based sealer: The material will be used according to the manufacturer's instruction and obturation will be performed
- Conditions
- Apical Periodontitis
- Being tested
- Zinc oxide based sealer, Epoxy resin based sealer, Bioactive silicone based sealer
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc oxide based sealerProcedure or surgery
After root canal treatment obturation will be done using zinc oxide eugenol based sealer.
Epoxy resin based sealerProcedure or surgery
After root canal treatment obturation will be done using epoxy resin based sealer.
Bioactive silicone based sealerProcedure or surgery
Also called After root canal treatment obturation will be done using bioactive silicone based sealer.
| Study group | Role | What they receive |
|---|---|---|
| Zinc oxide based sealer | Active comparator | After root canal treatment obturation with gutta percha will be done using zinc oxide based sealer. Receives: Procedure: Zinc oxide based sealer |
| Epoxy resin based sealer | Experimental | After root canal treatment obturation with gutta percha will be done using epoxy resin based sealer. Receives: Procedure: Epoxy resin based sealer |
| Bioactive silicone based sealer | Experimental | After root canal treatment obturation with gutta percha will be done using bioactive silicone based sealer. Receives: Procedure: Bioactive silicone based sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic success
Change in apical bone density will be measured by Periapical Index (PAI) score. PAI score equal to or less than 2 will be categorized as success.
Measured: 12 months
Clinical success
Absence of pain, sinus tract, swelling and mobility.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study startNov 2016
- Primary completionApr 2018
- Study completionApr 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397875
- Sponsor's protocol ID
- Aparna Tripathi
- Status last verified
- Apr 2018
- First submitted
- 31 Dec 2017
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Various Sealers on Healing of Teeth With Apical Periodontitis: A Clinical Study
- ClinicalTrials.gov ID
- NCT03397875
- Acronym / sponsor ID
- Aparna Tripathi
- Conditions
- Apical Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 12 Jan 2018 (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 effect of three different sealers on healing of teeth with apical periodontitis after primary root canal treatment.
Detailed description
Various sealers with different chemical composition and properties are available but it is yet not clear if one sealer is superior to other in terms of healing of apical periodontitis.
Three different groups of sealers will be used- a zinc oxide based sealer, an epoxy resin based sealer and a bioactive silicone based sealer. Mature mandibular permanent molar with the diagnosis of apical periodontitis (as confirmed clinically \& by periapical radiograph) will be chosen for the study. Primary non surgical root canal treatment will be performed. The sealer will be randomly selected just before obturation of root canals. The patient will be allotted to one of the three groups.
- Group I: Zinc oxide eugenol sealer group. The material will be mixed according to manufacturer instructions and applied to canals using a lentulospiral and the obturation will be performed.
- Group II: Epoxy resin based sealer group. The material will be mixed according to the manufacturer's instructions and obturation will be done.
- Group III: Bioactive silicone based sealer: The material will be used according to the manufacturer's instruction and obturation will be performed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zinc oxide based sealer | Active comparator | Procedure: Zinc oxide based sealerAfter root canal treatment obturation with gutta percha will be done using zinc oxide based sealer. |
| Epoxy resin based sealer | Experimental | Procedure: Epoxy resin based sealerAfter root canal treatment obturation with gutta percha will be done using epoxy resin based sealer. |
| Bioactive silicone based sealer | Experimental | Procedure: Bioactive silicone based sealerAfter root canal treatment obturation with gutta percha will be done using bioactive silicone based sealer. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patient willing to participate in the study.
- Age >18 years.
- No history of antibiotic use within the past month or requiring antibiotic premedication
- No history of prior analgesic use during past 24 hrs.
- Mature permanent mandibular molar having apical periodontitis requiring primary root canal treatment.
Key exclusion criteria (5 listed)
- Re-treatment
- Unwillingness of patients
- The presence of a difficult canal anatomy (root canals with an extreme curvature ≥30 deg), internal or external resorption and immature teeth.
- Accident or complication during treatment (calcified canals ,inability to achieve apical patency in any canals) Immuno-compromised, diabetic, pregnant and hypertensive patients.
- Teeth that are peridontally compromised
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 |
|---|---|---|
| Zinc oxide based sealerAfter root canal treatment obturation will be done using zinc oxide eugenol based sealer. | Procedure or surgery | Zinc oxide based sealer |
| Epoxy resin based sealerAfter root canal treatment obturation will be done using epoxy resin based sealer. | Procedure or surgery | Epoxy resin based sealer |
| Bioactive silicone based sealerAlso: After root canal treatment obturation will be done using bioactive silicone based sealer. | Procedure or surgery | Bioactive silicone based sealer |
Primary outcome
Radiographic success
Time frame: 12 months
Change in apical bone density will be measured by Periapical Index (PAI) score. PAI score equal to or less than 2 will be categorized as success.
Clinical success
Time frame: 12 months
Absence of pain, sinus tract, swelling and mobility.
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 17 Oct 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc oxide based sealer, Epoxy resin based sealer and Bioactive silicone based sealer in people with 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 7 inclusion and 5 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 17 Oct 2018. 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 success (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 17 Oct 2018.