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Apical PeriodontitisNCT04551209

"Effect of Apical Patency on Post-endodontic Pain"

A study testing Maintaining apical patency in people with Apical Periodontitis, run by National University of Medical Sciences, Pakistan at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to find out the effect of maintaining apical patency versus non maintaining apical patency on post-operative pain after single visit endodontic treatment in necrotic teeth with asymptomatic apical periodontitis Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Apical Periodontitis
What is being tested?
Maintaining apical patency
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 sitePakistan
Study dates
1 Jun 2020to 31 Dec 2020
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 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Necrotic Mandibular first molar teeth with asymptomatic apical periodontitis
  • Mandibular first molar teeth without any intra-oral or extra-oral swelling or any draining sinus

Who cannot join

  • Patients on preoperative analgesics and antibiotics
  • Mandibular first molars with calcified canals and open apex
  • Previously traumatized teeth and root canal treated teeth
  • Immune-compromised patients
  • pregnant and lactating mothers

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Afid, Nums

    Rawalpindi, Punjab Province, 46001

Other trials in Pakistan

About this study

Official title: "Effect Of Apical Patency On Post-Operative Pain After Single Visit Endodontic Treatment In Necrotic Teeth With Asymptomatic Apical Periodontitis: A Quasi Experimental Study"

This study is designed to find out the effect of maintaining apical patency versus non maintaining apical patency on post-operative pain after single visit endodontic treatment in necrotic teeth with asymptomatic apical periodontitis

Read the detailed description

After taking approval from the ethical committee (AFID No 905/Trg-ABP1K2), this study is planned at operative department in Armed Forces Institute of Dentistry, Rawalpindi from 01 June 2020 to 31 December 2020. Informed consent would be taken from 240 patients of 20-50 years of age from both gender with good general, mental and physical health who would be selected for this study and would be randomly divided into two equal groups with the help of scientific random number table.

The mandibular first molar teeth with asymptomatic apical periodontitis either with necrotic pulps, without any intra-oral or extra-oral swelling or any draining sinus tract will be selected for this study. Patients on preoperative analgesics and antibiotics, teeth with calcified canals and open apex, previously traumatized teeth and root canal treated teeth along with immune-compromised patients, pregnant and lactating mothers will be excluded from this study.

The patients reporting to the Operative Dentistry Department of Armed Forces Institute of Dentistry, Rawalpindi requiring root canals of their mandibular first molar will be screened for inclusion by taking history, performing relevant clinical examination and necessary investigations along with peri-apical radiographs. The whole procedure of the study will be explained to the patients in Urdu. After taking written informed consent from the willing participants of this study the procedure will be started. Two groups will be formed:

Group A: Patency group and Group B: Non-patency group Root canal treatment will be initiated under local anesthesia and rubber dam isolation. Working length will be taken with apex locator and will be confirmed with radiograph. The root canals will be instrumented with ProTaper Next system under copious irrigation with 5.25% sodium hypochlorite (NaOCl) and 17% EDTA solution.

In group A, a size 10 K file will be passed beyond the apical foramen between each instrument change to maintain apical patency while in group B, K file will be carried up to the working length only. A final peri-apical radiograph will be taken in the group A with the 10 K patency file 01mm beyond the apical foramen to confirm patency.

To control the microbiological impact on post-operative pain 2.5% sodium hypochlorite and 17% EDTA will be used as irrigants in both groups. Obturation will be done with cold lateral condensation using Pro Taper Next GP points and permanent restoration will be done with composite. At the end of this appointment patients will be given a visual analogue scale (VAS), and will be advised to mark at the scale according to his pain intensity after 24 hours and 48 hours after the treatment and will be asked to bring these reading with him on the next scheduled visit after one week for tooth preparation for metal ceramic crown. Patients will be given analgesic and will be advised to take it only in case of severe pain. VAS scores of less than 4 will be considered as no pain, score of 4-7 will be considered as mild and/or moderate pain and scores of 8 and above will be considered as severe pain. (no pain = <3, moderate pain = >4 to 7, severe pain = > 8). Frequencies, percentages, mean and standard deviation will be calculated for qualitative variable like inter appointment pain and for quantitative variables like gender; mean and standard deviation along with percentages in each group will be calculated with SPSS 22. Chi-square test will be used to compare the frequency of pain between the two groups after 24 and 48 hours of endodontic treatment. The p value of <0.05 will be considered significant.

Being tested
Maintaining apical patency
Medical subject headings
Periapical Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maintaining apical patencyProcedure or surgery

    In apical patency group, a size 10 K file will be passed beyond the apical foramen between each instrument change to maintain apical patency while in Non apical patency group, K file will be carried up to the working length only. A final peri-apical radiograph will be taken in the group A with the 10 K patency file 01mm beyond the apical foramen to confirm patency.

Study groups in NCT04551209
Study groupRoleWhat they receive
Apical patency groupExperimentalPatients in which apical patency is maintained.
Receives: Procedure: Maintaining apical patency
Non- apical patency groupNo interventionPatients in which apical patency is not maintained

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Post operative pain as determined by VAS (Visual Analogue Scale)

    To find out the incidence of post operative pain with Visual analogue scale after single visit endodontic treatment in necrotic teeth with asymptomatic apical periodontitis in two groups, Group A of 120 patients in which apical patency is maintained and Group B of 120 patients in which apical patency is non maintained. VAS (Visual Analogue Scale) will be used to measure pain. VAS scores of less than 4 will be considered as no pain, score of 4-7 will be considered as mild and/or moderate pain and scores of 8 and above will be considered as severe pain. (no pain = <3, moderate pain = >4 to 7, severe pain = > 8).

    Measured: 06 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study start1 Jun 2020
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04551209
Sponsor's protocol ID
905/Trg-ABP1K2
Status last verified
Mar 2021
First submitted
24 Jul 2020
Last updated
5 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Maintaining apical patency in people with Apical Periodontitis, run by National University of Medical Sciences, Pakistan 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 2 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 5 Mar 2021. 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?

Incidence of Post operative pain as determined by VAS (Visual Analogue Scale) (time frame: 06 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 5 Mar 2021.

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