Necrotic PulpNCT05744661
Mechanical Vs Chemomechanical Method For Calcium Hydroxide Removal
A study testing Mechanical Method and Chemomechanical Method in people with Necrotic Pulp and Chronic Apical Periodontitis, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
Type of study: Randomised Clinical trial To compare the effectiveness of Mechanical and Chemomechanical methods in the removal of Water-based Calcium hydroxide medicament from endodontic system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp, Chronic Apical Periodontitis
- What is being tested?
- Mechanical Method and Chemomechanical Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Dec 2022to 15 Jun 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SINGLE-ROOTED MAXILLARY AND MANDIBULAR TEETH
- NECROTIC TEETH WITH CHRONIC APICAL PERIODONTITIS
- STRAIGHT TO MODERATELY CURVED ROOT CANALS
Who cannot join
- PATIENTS WITH SYSTEMIC DISEASE
- PREGNANT AND IMMUNOCOMPROMISED PATIENTS
- TEETH WITH COMPROMISED PERIODONTAL HEALTH
- TEETH UNABLE TO BE RESTORED OR ISOLATED BY RUBBERDAM
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
School of Dentistry, Pakistan Institute of Medical Sciences
Islamabad
About this study
Official title: Effectiveness of Mechanical vs. Chemomechanical Methods in Removing Intracanal Calcium Hydroxide Medication: a Randomised Trial
Type of study: Randomised Clinical trial To compare the effectiveness of Mechanical and Chemomechanical methods in the removal of Water-based Calcium hydroxide medicament from endodontic system.
Participants allocated in group A and B should be appointed for Endodontic treatment of Single rooted teeth diagnosed with Necrotic Pulp and Chronic Apical Periodontitis.
In group A, Calcium hydroxide medicament will be removed by using Mechanical method while in group B, Calcium hydroxide will be removed by using Chemomechanical method.
Read the detailed description
This study is aimed at comparing the effectiveness of Mechanical and Chemomechanical methods for removal of Intracanal medication. Water-based Calcium hydroxide is used as an Intracanal medicament in this study. Participants aged 18 years and above presenting to the Outpatient department of Operative dentistry and Endodontics, School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad diagnosed with Necrotic Pulp with Chronic Apical Periodontitis will be randomly allocated in two groups A and B. On first visit, Root canal treatment will be initiated under rubber dam isolation. After locating canals, periapical radiograph for the working length will be taken. After working length has been confirmed, canal preparation will be done using Rotary file system. After canal has been prepared till working length, intracanal medicament is placed using Lentulospiral. Patient is recalled after 2 weeks. On next visit, Calcium hydroxide medicament will be removed by Mechanical method from group A. Mechanical method involves the use of Rotary file system for removal of medicament. In group B, Calcium hydroxide will be removed by using Chemomechanical method. Chemomechanical method involves the use of Sonic or Ultrasonic activation of irrigants for removal of medicament. After the removal of intracanal medicament, Periodical radiograph will be taken. Data will be taken on proforma and evaluation will be done for the effective removal of calcium hydroxide using a 4- point scoring system.
- Conditions
- Necrotic Pulp, Chronic Apical Periodontitis
- Being tested
- Mechanical Method, Chemomechanical Method
- Keywords
- Mechanical Method, Chemomechanical Method, Calcium Hydroxide, Intracanal Medicament
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical MethodOther
Use of Rotary Master Apical file for the removal of Calcium Hydroxide Medicament from Root Canal System
Chemomechanical MethodOther
Sonic Activation of Endodontic irrigants for the removal of Calcium Hydroxide from Root Canal System
| Study group | Role | What they receive |
|---|---|---|
| Group A (Mechanical Method) | Experimental | In Group A, Calcium Hydroxide Intracanal Medicament will be removed by using Mechanical Method in which Rotary Master Apical File will be used . Receives: Other: Mechanical Method |
| Group B ( Chemomechanical Method) | Experimental | In Group B, Calcium Hydroxide Intracanal Medicament will be removed by using Chemomechanical Method which involves Sonic Agitation of Endodontic irrigants. Receives: Other: Chemomechanical Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective removal of Water-based Calcium hydroxide Intracanal medicament
The effectiveness of mechanical and chemomechanical methods for the removal of calcium hydroxide will be evaluated using a 4 graded scoring system used in endodontics.
Measured: Two week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start16 Dec 2022
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Necrotic PulpStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a Parallel type, Non-random Consecutive Sampling Technique. Patients reporting to the Department of Operative Dentistry \& Endodontics, School of Dentistry with Necrotic teeth will be filtered. All participants who fulfil the Inclusion and Exclusion criteria will be enrolled in this study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, NEHAL AMIR, Pakistan Institute of Medical Sciences
- Investigators
- Nehal Amir, BDS, Principal investigator, Pakistan Institiute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744661
- Sponsor's protocol ID
- PakistanIMS
- Status last verified
- Sep 2023
- First submitted
- 16 Feb 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anis Motiwala M, Badar SB, Ghafoor R. Comparison of Two Different Methods in the Removal of Oil-Based Calcium Hydroxide From Root Canal System: A Triple-Blinded Randomised Clinical Trial. Eur Endod J. 2021 Mar;6(1):38-43. doi: 10.14744/eej.2020.78941.
PubMed 33907070Amir N, Noor N. Effectiveness of mechanical vs. chemomechanical methods in removing intracanal calcium hydroxide medication: a randomised trial. J Pak Med Assoc. 2024 Oct;74(10):1749-1754. doi: 10.47391/JPMA.10990.
PubMed 39407365
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mechanical vs. Chemomechanical Methods in Removing Intracanal Calcium Hydroxide Medication: a Randomised Trial
- ClinicalTrials.gov ID
- NCT05744661
- Acronym / sponsor ID
- PakistanIMS
- Conditions
- Necrotic Pulp, Chronic Apical Periodontitis
- Keywords
- Mechanical Method, Chemomechanical Method, Calcium Hydroxide, Intracanal Medicament
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 27 Feb 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.
Type of study: Randomised Clinical trial To compare the effectiveness of Mechanical and Chemomechanical methods in the removal of Water-based Calcium hydroxide medicament from endodontic system.
Participants allocated in group A and B should be appointed for Endodontic treatment of Single rooted teeth diagnosed with Necrotic Pulp and Chronic Apical Periodontitis.
In group A, Calcium hydroxide medicament will be removed by using Mechanical method while in group B, Calcium hydroxide will be removed by using Chemomechanical method.
Detailed description
This study is aimed at comparing the effectiveness of Mechanical and Chemomechanical methods for removal of Intracanal medication. Water-based Calcium hydroxide is used as an Intracanal medicament in this study. Participants aged 18 years and above presenting to the Outpatient department of Operative dentistry and Endodontics, School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad diagnosed with Necrotic Pulp with Chronic Apical Periodontitis will be randomly allocated in two groups A and B. On first visit, Root canal treatment will be initiated under rubber dam isolation. After locating canals, periapical radiograph for the working length will be taken. After working length has been confirmed, canal preparation will be done using Rotary file system. After canal has been prepared till working length, intracanal medicament is placed using Lentulospiral. Patient is recalled after 2 weeks. On next visit, Calcium hydroxide medicament will be removed by Mechanical method from group A. Mechanical method involves the use of Rotary file system for removal of medicament. In group B, Calcium hydroxide will be removed by using Chemomechanical method. Chemomechanical method involves the use of Sonic or Ultrasonic activation of irrigants for removal of medicament. After the removal of intracanal medicament, Periodical radiograph will be taken. Data will be taken on proforma and evaluation will be done for the effective removal of calcium hydroxide using a 4- point scoring system.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a Parallel type, Non-random Consecutive Sampling Technique. Patients reporting to the Department of Operative Dentistry \& Endodontics, School of Dentistry with Necrotic teeth will be filtered. All participants who fulfil the Inclusion and Exclusion criteria will be enrolled in this study.
| Arm | Type | Receives |
|---|---|---|
| Group A (Mechanical Method) | Experimental | Other: Mechanical MethodIn Group A, Calcium Hydroxide Intracanal Medicament will be removed by using Mechanical Method in which Rotary Master Apical File will be used . |
| Group B ( Chemomechanical Method) | Experimental | Other: Chemomechanical MethodIn Group B, Calcium Hydroxide Intracanal Medicament will be removed by using Chemomechanical Method which involves Sonic Agitation of Endodontic irrigants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- SINGLE-ROOTED MAXILLARY AND MANDIBULAR TEETH
- NECROTIC TEETH WITH CHRONIC APICAL PERIODONTITIS
- STRAIGHT TO MODERATELY CURVED ROOT CANALS
Key exclusion criteria (4 listed)
- PATIENTS WITH SYSTEMIC DISEASE
- PREGNANT AND IMMUNOCOMPROMISED PATIENTS
- TEETH WITH COMPROMISED PERIODONTAL HEALTH
- TEETH UNABLE TO BE RESTORED OR ISOLATED BY RUBBERDAM
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 |
|---|---|---|
| Mechanical MethodUse of Rotary Master Apical file for the removal of Calcium Hydroxide Medicament from Root Canal System | Other | Group A (Mechanical Method) |
| Chemomechanical MethodSonic Activation of Endodontic irrigants for the removal of Calcium Hydroxide from Root Canal System | Other | Group B ( Chemomechanical Method) |
Primary outcome
Effective removal of Water-based Calcium hydroxide Intracanal medicament
Time frame: Two week
The effectiveness of mechanical and chemomechanical methods for the removal of calcium hydroxide will be evaluated using a 4 graded scoring system used in endodontics.
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 21 Sep 2023.
- Background: PubMed 33907070Anis Motiwala M, Badar SB, Ghafoor R. Comparison of Two Different Methods in the Removal of Oil-Based Calcium Hydroxide From Root Canal System: A Triple-Blinded Randomised Clinical Trial. Eur Endod J. 2021 Mar;6(1):38-43. doi: 10.14744/eej.2020.78941.
- Derived from this study: PubMed 39407365Amir N, Noor N. Effectiveness of mechanical vs. chemomechanical methods in removing intracanal calcium hydroxide medication: a randomised trial. J Pak Med Assoc. 2024 Oct;74(10):1749-1754. doi: 10.47391/JPMA.10990.
- 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.
Nehal Amir, BDS principal investigator
Pakistan Institiute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Method and Chemomechanical Method in people with Necrotic Pulp and Chronic Apical Periodontitis, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
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 3 inclusion and 4 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 21 Sep 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 Pakistan. 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?
Effective removal of Water-based Calcium hydroxide Intracanal medicament (time frame: Two week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05744661, which also lists 2 linked publications.
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 21 Sep 2023.