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Irreversible PulpitisNCT05038059

Ethanolic Extract of Sapindus Mukorrossi as Final Endodontic Irrigant.

A study testing ethanolic extract of sapindus mukorossi and ethylene diamine tetra acetic acid in people with Irreversible Pulpitis and Apical Periodontitis, run by Dow University of Health Sciences 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

The chief aim of root canal treatment is to reduce the microbial content and prevent further recontamination in the canal. Properly cleaned, shaped and obturated teeth will be having fewer chances of treatment failure. Every tooth has variable, complex canal anatomy consisting of ramifications and lateral canal. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
What is being tested?
ethanolic extract of sapindus mukorossi and ethylene diamine tetra acetic acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 sitePakistan
Study dates
2 Apr 2020to 1 Sep 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 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Extracted single rooted teeth with mature apices. (carious/ non carious)
  • Teeth extracted for orthodontic and periodontal purpose.
  • Patient age between 18 to 40 years.

Who cannot join

  • Intracanal calcification. (will be assessed from pre-operative radiograph before extraction)
  • Root dilacerations.
  • Root caries, fracture or cracked.
  • Root resorption.
  • Previously treated or initiated root canal treatment.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Dr. Araib Tahir

    Karachi, Sindh

Other trials in Pakistan

About this study

Official title: Ethanolic Extract of Sapindus Mukorossi as the Final Endodontic Irrigant.

The chief aim of root canal treatment is to reduce the microbial content and prevent further recontamination in the canal. Properly cleaned, shaped and obturated teeth will be having fewer chances of treatment failure. Every tooth has variable, complex canal anatomy consisting of ramifications and lateral canal. The instrumentation alone cannot reach all the areas for cleaning. For proper cleaning and removal of all microorganisms, the canal should be irrigated with any biocompatible, lubricant and antimicrobial agent. An irrigant should have a high compatibility factor, with canals, with obturating material and sealer. It should remove all the superficial barriers from canal tubules and allow sealer penetration, which aids in better adhesion and decreases the chances for recontamination.

Objectives: This study aims to compare the effect of experimental endodontic irrigant Sapindus mukorossi with 17% EDTA, on the microleakage, sealer penetration and interaction with sodium hypochlorite.

Read more

Ninety single-rooted teeth will be allocated into 2 experimental groups and a control group of 30 teeth each. The endodontic procedure will be done with protaper files. The sample in group 1 will be irrigated with 3.0% NaOCl after that by 17% EDTA and the sample in group 2 final irrigation will be given with Ethanolic extract of Sapindus mukorossi. After the preparation and final irrigation of all teeth, sterile saline will be used to flush all canals and dried using paper points. Obturation will be done with lateral condensation by gutta-percha. Teeth will be incubated at 37ºc and 100% humidity for 7 days. Varnish will be applied on the root surface except for apical 3mm. The teeth will be sectioned longitudinally and examined at 2 and 5mm from the root apex. The maximum depth of sealer penetration will be measured using a scanning electron microscope and microleakage will be tested through a dye penetration method under a stereomicroscope.

Testing of interaction between irrigant and hypochlorite will be done by placing 1ml irrigant with 1 ml sodium hypochlorite in a round bottom test tube and left for 1 week at 37ºc. An independent observer will look for precipitation formation or color changes

Read the detailed description

Preparation of ethanolic extract of S.mukorossi:

The desiccated fruit of Sapindus mukorossi will be used for the formulation of an experimental root canal irrigant. The dry pericarps of s. mukorossi (≈ 1.0 kg) which is present around the seed nut, will be separated with a sharp blade. These pericarps will be blended to produce fine particles in a sterilized home blender (Enviro 3 in 1 juicer blender ENJ301). The resultant 10gram powder will be soaked in 100ml of absolute ethanol (99%) for 24hours at normal room temperature. This solvent will be filtered and removed with help of a rotary evaporator, and extract will be kept in cleaned screw-capped vials (Premium Vials B4702-12 Glass with Screw Cap) at -20º C until use. To form an operational concentration of 5 mg/ml, the extract will be re-dissolved in distilled water.

All samples were prepared by a single operator using the following protocol. After extraction tooth was stored in 0.1% thymol. Until further use. Specimens were randomly divided into 3 groups through computer-generated software. There will be 30 teeth in each group.

Chamber opening was done with # 4 diamond cutting round bur, a #10 K-type file (Maillefer/Dentsply) was introduced into each root canal till it could be seen outside the apical foramen. The working length will be decided by decreasing this length by 1mm. A single operator using K-type files (Maillefer/Dentsply) initially than with the ProTaper Universal System (Dentsply-Maillefer) up to F2 was performed. Irrigation was performed at each change of file with 2.5mL of 3% NaOCl (canasol). After instrumentation the sample Group 1 would be irrigated with 3ml of 17% EDTA and left in the canal for 1 minute. Group 2 will be irrigated with Sapindus mukorossi finally all groups will be flushed with 5ml of 0.9% normal saline. The control group's final irrigation was done with 0.9% saline.

Afterward, the specimen was dried with F2 sterile absorbent paper points and an F2 gutta-percha cone was selected as the master cone. Sealapex (Sybron-Endo, Glendora, CA, USA) sealer was mixed according to the manufacturer's instructions and placed in the canal via the help of a 25# k file.

  • Mastercone was inserted up to the working length and tug back was assessed.
  • Sealer application was performed in the manner described above.
  • The GP was inserted up to the working length after the apical 2mm of the master cone was evenly coated with the sealer.
  • The finger spreaders #25 and #20 (MANI, Japan) were placed into the canal to make room for the accessory GP.
  • The process was repeated until the #20 spreader was unable to enter the canal's coronal one-third.
  • Excess GP was seared off using a hot condenser, and coronal GP was vertically compacted to produce a good coronal seal.
  • The access cavity was sealed with GIC restorative type(3M, ESPE) All samples were stored in an incubator (binder GmbH, Germany) at 37oc under 100% humidity for 1 week, to allow for the sealer to set completely.

3.10.1 Preparation of the sample for stereomicroscopic analysis of dye penetration: After the samples were retrieved from the incubator they were allowed to air dry for 10 minutes. All samples in the experimental group were coated with two layers of colored nail varnish, except the apical 2mm of the root apex.

After complete drying of nail varnish, the roots were then vertically placed in 1% methylene blue dye (WellcoSol, TM) for 72hours.

After 3 days, the samples were washed for 5 minutes under running tap water and left to air dry fully. To avoid dye introduction onto the inner root surface during sectioning, nail polish and dye were scraped off the samples with a scalpel and surgical blade #15 (Bisturi Ucu, Turkey). The tooth was cut in half longitudinally, parallel to its long axis. To ensure that the sectioning was performed through the center of the root and to prevent damage to the obturated canal space, 2mm deep longitudinal grooves were placed in the center of the buccal and lingual root surface using a diamond disc in a slow-speed handpiece (Nakanishi Inc (NSK), Japan), with caution not to invade the canal space. The teeth were then fractured longitudinally with a double tapered chisel and a mallet, preserving the entire obturation space.

The samples were then viewed under Stereiomicroscope (Olympus VM-ILA-2) in the bioinformatics and Molecular Medicine Laboratory (DRIBBS, DUHS) under 30x magnification. The images were captured and uploaded to IMAGE J software (National Institute of Health, USA). The samples were examined by two blinded observers (endodontists). The investigator determined apical microleakage by measuring the linear depth of dye penetration, which is defined as the maximum dye penetration distance from the root apex to the coronal extent. In the performa, all measures were measured in millimeters (mm).

For dentinal tubule penetrance:

Another half of the tooth was left to desiccate for 24 hours in 40-100% ethyl alcohol. Then specimen will be mounted on metallic stubs and gold-sputtered. Under an electron microscope, a photomicrograph will be taken. Samples were studied for dentinal tubule penetration of sealers at two levels - 2 and 5mm from the root apex by two independent observer's reliability will be checked. Photomicrographs showing the maximum penetration at each level were taken. The distance of the points was measured from the sealer-dentin interface and the depth of penetration was calculated.

For interaction with sodium hypochlorite:

For the assessment of precipitate formation, solutions of 17% EDTA, S.mukorossi, and 3% NaOCl will be used. Each polystyrene round-bottom tube (Falcon; Thermo Fischer Scientific, Waltham, MA) will be filled with 2mL extract of S. mukorossi and17% EDTA respectively. Tube 3 will be filled with a mixture of 1 mL of S.mukorossi and 1 mL 3% NaOCl. Tube 4 was filled with 17% EDTA with NaoCl. Left on 95% humidity at 37ºC for 1 week. An unbiased observer was observing every tube for precipitate formation after every 15minutes for first 2 hours and at 24-hour intervals for 1 week. To avoid any error this procedure repeated 3 times

Being tested
ethanolic extract of sapindus mukorossi, ethylene diamine tetra acetic acid
Medical subject headings
Periapical Periodontitis

What participants receive

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

  • ethanolic extract of sapindus mukorossiDrug

    Also called extract of soapnut

    ethanolic extract will be used as final endodontic irrigant during root canal procedures in extracted teeth.

  • ethylene diamine tetra acetic acidDrug

    Also called edta

    used as final endodontic irrigant in root canal therapy

Study groups in NCT05038059
Study groupRoleWhat they receive
1. Ethylene diammine tetra acetic acid groupActive comparatorsamples will be rinsed with ethylene diamine tetra acetic acid group, which is the gold standard for final rinse and compares with the experimental group.
Receives: Drug: ethylene diamine tetra acetic acid
2. Control groupNo interventionno final irrigant will be used and evaluate the outcomes
3. Experimental groupExperimentalfinal irrigation of root canal will be done with ethanolic extract of sapindus mukorossi
Receives: Drug: ethanolic extract of sapindus mukorossi

What is being measured

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

  1. microleakage

    measured in milimeter by steriomicroscope

    Measured: in a month

  2. dentinal tubule penetration of selaer

    measured in micrometer by scanning electron microscope

    Measured: 2 months

  3. interaction of extract of sapindus mukorossi with hypochlorite

    precipitate formation visible with naked eye

    Measured: in 4 weeks

Timeline

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

  1. First posted8 Sep 2021
  2. Study start2 Apr 2020
  3. Primary completion3 Jun 2021
  4. Study completion1 Sep 2021

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
Model description
3 groups assigned 2 with interventions and 1 control group.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05038059
Sponsor's protocol ID
A_tahir
Status last verified
Aug 2021
First submitted
25 Aug 2021
Last updated
8 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Thaha KA, Varma RL, Nair MG, Sam Joseph VG, Krishnan U. Interaction between Octenidine-based Solution and Sodium Hypochlorite: A Mass Spectroscopy, Proton Nuclear Magnetic Resonance, and Scanning Electron Microscopy-based Observational Study. J Endod. 2017 Jan;43(1):135-140. doi: 10.1016/j.joen.2016.09.015. Epub 2016 Dec 6.

    PubMed 27939737
  • Pommel L, About I, Pashley D, Camps J. Apical leakage of four endodontic sealers. J Endod. 2003 Mar;29(3):208-10. doi: 10.1097/00004770-200303000-00011.

    PubMed 12669883
  • Farhad AR, Barekatain B, Koushki AR. The Effect of Three Different Root Canal Irrigant Protocols for Removing Smear Layer on the Apical Microleakage of AH26 Sealer. Iran Endod J. 2008 Summer;3(3):62-7. Epub 2008 Jul 10.

    PubMed 24146672
  • Violich DR, Chandler NP. The smear layer in endodontics - a review. Int Endod J. 2010 Jan;43(1):2-15. doi: 10.1111/j.1365-2591.2009.01627.x.

    PubMed 20002799
  • Bloomfield SF, Miles GA. The antibacterial properties of sodium dichloroisocyanurate and sodium hypochlorite formulations. J Appl Bacteriol. 1979 Feb;46(1):65-73. doi: 10.1111/j.1365-2672.1979.tb02582.x. No abstract available.

    PubMed 35510
  • Kuci A, Alacam T, Yavas O, Ergul-Ulger Z, Kayaoglu G. Sealer penetration into dentinal tubules in the presence or absence of smear layer: a confocal laser scanning microscopic study. J Endod. 2014 Oct;40(10):1627-31. doi: 10.1016/j.joen.2014.03.019. Epub 2014 May 10.

    PubMed 25260735

Questions about this trial

What is this clinical trial studying?

A study testing ethanolic extract of sapindus mukorossi and ethylene diamine tetra acetic acid in people with Irreversible Pulpitis and Apical Periodontitis, run by Dow University of Health 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 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 8 Sep 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?

microleakage (time frame: in a month). The study lists 3 primary outcomes in all. 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 NCT05038059, which also lists 6 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 8 Sep 2021.

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