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Periapical AbscessPhase 2/3NCT02943759

Resolution of Pain and Swelling After the Use of Neem Leaf Extract Compared to Chlorhexidine Gluconate as an Intracanal Irrigant During Pulpectomy

A Phase 2/3 study testing Neem leaf extract and Chlorhexidine gluconate in people with Periapical Abscess, run by Cairo University at 1 site in Egypt.

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 trial is to test the resolution of pain, swelling and other signs of periapical infection and the antimicrobial efficacy when using the neem leaf extract compared to chlorhexidine as root canal irrigant in Pulpectomy treatment for children. Read more about this study

Who is it for?
Ages 4 to 8 yearsHealthy volunteers can take part
Conditions the study is for
Periapical Abscess
What is being tested?
Neem leaf extract and Chlorhexidine gluconate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Dec 2016to 1 Feb 2018
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 4 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Patient and parent cooperation.
  • Absence of any systemic disease that would contraindicate pulp therapy.
  • Non vital molar teeth presenting with an acute or chronic periapical infection as a result of pulp necrosis ( Periapical abscess ,a sinus tract formation as a sequelae )
  • Making sure the patient is not taking an antibiotic and has not taken it for the past 2 weeks.
  • Absence of physiologic or pathologic root resorption that contraindicate pulp therapy.
  • Restorable teeth
  • Molars with at least two thirds of root remaining.

Who cannot join

  • Children with any condition that contraindicates pulp therapy will be excluded (rheumatic fever, infective endocarditis , leukemia , corticosteroid therapy and immunosuppressed children).

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Pediatric dentistry and Public health department-Cairo University

    Cairo

Other trials in Egypt

About this study

Official title: Resolution of Pain and Swelling After the Use of Neem Leaf Extract (Azadirachta Indica) Compared to Chlorhexidine Gluconate as an Intracanal Irrigant in Necrotic Primary Molar Teeth in Children Undergoing Pulpectomy Treatment: A Randomised Controlled Trial

The trial is to test the resolution of pain, swelling and other signs of periapical infection and the antimicrobial efficacy when using the neem leaf extract compared to chlorhexidine as root canal irrigant in Pulpectomy treatment for children.

Read the detailed description

To compare the effectiveness of neem leaf extract with that of Chlorhexidine gluconate when used as an intracanal irrigant in primary molar teeth indicated for pulpectomy treatment.

P: children with primary necrotic molars indicated for pulpectomy I: Neem leaf extract (alcoholic solution). C: 2% chlorhexidine gluconate. O: Pain and swelling resolution. T:Over 12 months. S: Randomised controlled trial.

Being tested
Neem leaf extract, Chlorhexidine gluconate
Medical subject headings
Periapical Abscess

What participants receive

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

  • Neem leaf extractDrug

    A natural irrigant solution act as anti-inflammatory and anti bacterial

  • Chlorhexidine gluconateDrug

    Also called Gluconate-Chex 2%

    2%chlorhexidine gluconate , anti bacterial root canal irrigant solution

Study groups in NCT02943759
Study groupRoleWhat they receive
Neem leaf extractExperimentalNeem leaf extract (alcoholic solution) used as an anti inflammatory , antibacterial irrigant
Receives: Drug: Neem leaf extract
Chlorhexidine gluconateActive comparator2% chlorhexidine gluconate intracanal irrigant solution used as an antibacterial chemical mean for canal irrigation
Receives: Drug: Chlorhexidine gluconate

What is being measured

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

  1. Pain

    Patient reported pain and pain on percussion , binary

    Measured: 1 year

  2. Swelling

    Visual examination ,binary

    Measured: 1 year

  3. Mobility

    Mobility test ,binary

    Measured: 1 year

Secondary outcomes (2)

  1. Bacterial load

    Bacteria on culture plates measuring unit CFU/ml

    Measured: 48 hours

  2. Periapical pathosis

    Periapical radiograph , binary

    Measured: 1 year

Timeline

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

  1. First posted25 Oct 2016 (estimated)
  2. Study start1 Dec 2016
  3. Primary completion1 Feb 2018
  4. Study completion1 Feb 2018

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02943759
Sponsor's protocol ID
Chx_neemleaf
Status last verified
Jul 2019
First submitted
21 Oct 2016
Last updated
31 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dutta A, Kundabala M. Comparative anti-microbial efficacy of Azadirachta indica irrigant with standard endodontic irrigants: A preliminary study. J Conserv Dent. 2014 Mar;17(2):133-7. doi: 10.4103/0972-0707.128047.

    PubMed 24778508

  • Ercan E, Ozekinci T, Atakul F, Gul K. Antibacterial activity of 2% chlorhexidine gluconate and 5.25% sodium hypochlorite in infected root canal: in vivo study. J Endod. 2004 Feb;30(2):84-7. doi: 10.1097/00004770-200402000-00005.

    PubMed 14977302

  • Louwakul P, Prucksathamrongkul W. The effect of 2% chlorhexidine as root canal irrigant in pulpectomies of primary molars. Pediatr Dent. 2012 Nov-Dec;34(7):e192-6.

    PubMed 23265154

  • Podar R, Kulkarni GP, Dadu SS, Singh S, Singh SH. In vivo antimicrobial efficacy of 6% Morinda citrifolia, Azadirachta indica, and 3% sodium hypochlorite as root canal irrigants. Eur J Dent. 2015 Oct-Dec;9(4):529-534. doi: 10.4103/1305-7456.172615.

    PubMed 26929692

  • Ruiz-Esparza CL, Garrocho-Rangel A, Gonzalez-Amaro AM, Flores-Reyes H, Pozos-Guillen AJ. Reduction in bacterial loading using 2% chlorhexidine gluconate as an irrigant in pulpectomized primary teeth: a preliminary report. J Clin Pediatr Dent. 2011 Spring;35(3):265-70. doi: 10.17796/jcpd.35.3.y052311j23617837.

    PubMed 21678668

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Neem leaf extract and Chlorhexidine gluconate in people with Periapical Abscess, run by Cairo University at 1 site in Egypt.

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 1 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 31 Jul 2019. 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 Egypt. 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?

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?

Pain (time frame: 1 year). 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 NCT02943759, which also lists 5 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 31 Jul 2019.

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