Periapical AbscessPhase 2/3NCT04319575
Comparison of Triple Antibiotic Paste With Combination of Chitosan and Calcium Hydroxide as a Root Canal Disinfectant
A Phase 2/3 study testing root canal treatment and intracanal medicament in people with Periapical Abscess, run by Dr. D. Y. Patil Dental College & Hospital at 1 site in India.
Trial summary
Investigators observed the clinical and radiographic healing of periapical lesion using Chitosan mixed with calcium hydroxide and compared it with triple antibiotic paste when used as intracanal medicament in 3months, 6 months and 12 months. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Abscess
- What is being tested?
- root canal treatment and intracanal medicament
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 3 Dec 2018to 4 Aug 2020
- Phase
- Phase 2/3
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged between 18 and 40 years Periapical lesion (not more than 5mm) radiographically.on single rooted teeth
- Roots with closed apex.
- Systemically healthy patients.
- Exclusion Criteria:All patients who respond positive to allergic patch test [triple antibiotic paste] and drugs.
- Teeth with previous endodontic therapy performed.
- Patients with a history of any systemic diseases.
Show all 11Show fewer
- Pregnant and lactating women.
- Tooth associated with vertical root fracture and coronal perforation.
- Tooth affected with calcific degeneration.
- Presence of external or internal root resorption.
- Blunderbuss apex.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dr DY Patil Dental College And Hospital (DPU)
Pune, Maharashtra, 411 018
Soumya S Shetty, MDS, 8888200888, drsoumyasshetty@gmail.com
anita B Tandale, MDS, 9850537432, anita.tandale@gmail.com
About this study
Official title: Clinical and Radiographic Comparative Evaluation of Healing of Periapical Lesion Using Triple Antibiotic Paste With Combination of Chitosan and Calcium Hydroxide When Used as a Root Canal Disinfectant- An In Vivo Study
Investigators observed the clinical and radiographic healing of periapical lesion using Chitosan mixed with calcium hydroxide and compared it with triple antibiotic paste when used as intracanal medicament in 3months, 6 months and 12 months.
Read the detailed description
Aim: To evaluate and compare the healing of periapical lesions using chitosan mixed with calcium hydroxide or Triple Antibiotic Paste at 3,6 and 12 months.
Methodology:
20 adult patients having periapical lesions in single rooted teeth were selected in this study after being assessed using the PAI index. Patients were randomly assigned to: Group - I (n=10) Chitosan with Ca (OH)2 and Group -II (n=10) Triple Antibiotic paste (TAP)
After access opening and cleaning and shaping were done in the first visit, the pertinent intracanal medicaments were placed depending on the patient group. After 4 weeks, on the second visit, the medicament was removed andobturation was done in the asymptomatic teeth. Both clinical and radiographic endodontic evaluation was done at 0, 3, 6 and 12months using the same parameters.
Radiographic evaluation was done using the PAI Index and was compared at 0, 3, 6, and 12 months after treatment, Z Test.
- Conditions
- Periapical Abscess
- Being tested
- root canal treatment and intracanal medicament
- Medical subject headings
- Periapical Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal treatment and intracanal medicamentDrug
Also called intra-oral periapical radiaograph,"kodak"
after the access preparation and cleaning and shaping was done in 1st appointment using k files,"Mani" and protapers,"Dentsply" then in, chitosan calcium hydroxide paste," or ciprofloxacin metronidazole minocycline paste placed in the canal and kept for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Chitosan calcium hyroxide paste | Experimental | after the access preparation and cleaning and shaping, chitosan calcium hydroxide paste will be placed in the canal and kept for 4 weeks. Receives: Drug: root canal treatment and intracanal medicament |
| triple antibiotic paste | Active comparator | after the access preparation and cleaning and shaping, ciprofloxacin metronidazole minocycline paste will be :placed in the canal and kept for 4 weeks. Receives: Drug: root canal treatment and intracanal medicament |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing of periapical lesion
the periapical status will be assessed by using the periapical index [PAI] using radiographs and scoring was done according to following scoring index as
- Normal periapical structures
- Small changes in bone structure
- Changes in bone structure with some mineral loss
- Periodontitis with well-defined radiolucent area
- Severe periodontitis with exacerbating features
Measured: change in PAI index from baseline to 3 months, baseline to 6 months and baseline to 12 months
Secondary outcomes (1)
patient pain perception
pain will be assessed using visual analogue (VAS )scale along with any swelling following scale of -10 with 0 score depicts no pain and score 10 depicts severe pain
Measured: 3months, 6months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start3 Dec 2018
- Primary completion23 Apr 2020 (estimated)
- Study completion4 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical AbscessStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. D. Y. Patil Dental College & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soumya Shetty, Dr. D. Y. Patil Dental College & Hospital
- Investigators
- Piyush D Oswal, MDS, Study director, Dr. D Y Patil Dental College, Pimpri, Pune
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319575
- Sponsor's protocol ID
- DYPV/EC/55/16
- Status last verified
- Mar 2020
- First submitted
- 18 Mar 2020
- Last updated
- 24 Mar 2020
- 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 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Comparative Evaluation of Healing of Periapical Lesion Using Triple Antibiotic Paste With Combination of Chitosan and Calcium Hydroxide When Used as a Root Canal Disinfectant- An In Vivo Study
- ClinicalTrials.gov ID
- NCT04319575
- Acronym / sponsor ID
- DYPV/EC/55/16
- Conditions
- Periapical Abscess
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dr. D. Y. Patil Dental College & HospitalUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 23 Apr 2020 (estimated)
- Study completion
- 4 Aug 2020 (estimated)
- First posted
- 24 Mar 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.
Investigators observed the clinical and radiographic healing of periapical lesion using Chitosan mixed with calcium hydroxide and compared it with triple antibiotic paste when used as intracanal medicament in 3months, 6 months and 12 months.
Detailed description
Aim: To evaluate and compare the healing of periapical lesions using chitosan mixed with calcium hydroxide or Triple Antibiotic Paste at 3,6 and 12 months.
Methodology:
20 adult patients having periapical lesions in single rooted teeth were selected in this study after being assessed using the PAI index. Patients were randomly assigned to: Group - I (n=10) Chitosan with Ca (OH)2 and Group -II (n=10) Triple Antibiotic paste (TAP)
After access opening and cleaning and shaping were done in the first visit, the pertinent intracanal medicaments were placed depending on the patient group. After 4 weeks, on the second visit, the medicament was removed andobturation was done in the asymptomatic teeth. Both clinical and radiographic endodontic evaluation was done at 0, 3, 6 and 12months using the same parameters.
Radiographic evaluation was done using the PAI Index and was compared at 0, 3, 6, and 12 months after treatment, Z Test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chitosan calcium hyroxide paste | Experimental | Drug: root canal treatment and intracanal medicamentafter the access preparation and cleaning and shaping, chitosan calcium hydroxide paste will be placed in the canal and kept for 4 weeks. |
| triple antibiotic paste | Active comparator | Drug: root canal treatment and intracanal medicamentafter the access preparation and cleaning and shaping, ciprofloxacin metronidazole minocycline paste will be :placed in the canal and kept for 4 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Patients aged between 18 and 40 years Periapical lesion (not more than 5mm) radiographically.on single rooted teeth
- Roots with closed apex.
- Systemically healthy patients.
- Exclusion Criteria:All patients who respond positive to allergic patch test [triple antibiotic paste] and drugs.
- Teeth with previous endodontic therapy performed.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| root canal treatment and intracanal medicamentAlso: intra-oral periapical radiaograph,"kodak"after the access preparation and cleaning and shaping was done in 1st appointment using k files,"Mani" and protapers,"Dentsply" then in, chitosan calcium hydroxide paste," or ciprofloxacin metronidazole minocycline paste placed in the canal and kept for 4 weeks. | Drug | Chitosan calcium hyroxide paste, triple antibiotic paste |
Primary outcome
healing of periapical lesion
Time frame: change in PAI index from baseline to 3 months, baseline to 6 months and baseline to 12 months
the periapical status will be assessed by using the periapical index [PAI] using radiographs and scoring was done according to following scoring index as 1. Normal periapical structures 2. Small changes in bone structure 3. Changes in bone structure with some mineral loss 4. Periodontitis with well-defined radiolucent area 5. Severe periodontitis with exacerbating features
1 secondary outcome
patient pain perception
Time frame: 3months, 6months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
Related trials for Periapical Abscess
Active, not recruitingObservational study
A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
Periapical Periodontitis, Periapical Abscess
Recruiting
Antibacterial Effects of Intracanal Medicaments in Acute Apical Abscesses
Acute Apical Abscess
RecruitingPhase 1
Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases
Intervention Studies, ASA Physical Status I
Not yet recruitingEarly Phase 1
Chloramphenicol, Tetracycline, Zinc Oxide and Eugenol Paste (CTZ Paste) for Emergency Dental Treatment in Public Health Settings: A Randomized Trial
Pulp Disease, Dental, Pulp Necrosis
Not yet recruiting
Using Platelet-rich Fibrin in Regenerative Endodontic Treatment in Mature Permanent Teeth
Chronic Apical Periodontitis, Necrosis of Pulp
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.
Piyush D Oswal, MDS study director
Dr. D Y Patil Dental College, Pimpri, Pune
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing root canal treatment and intracanal medicament in people with Periapical Abscess, run by Dr. D. Y. Patil Dental College & Hospital 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 11 inclusion and 0 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 24 Mar 2020. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Soumya S Shetty, MDS (8888200888, drsoumyasshetty@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing of periapical lesion (time frame: change in PAI index from baseline to 3 months, baseline to 6 months and baseline to 12 months). 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 24 Mar 2020.