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Status unknownNCT03408626Updated Jan 31, 2019

Microbiological Assessment After Chemo-Mechanical Caries Removal Using Papain-based Enzyme Versus Conventional Rotary Tools in Occlusal Carious Lesions

An interventional study of Papain-based Chemo-mechanical caries removal agent and conventional rotary in Microbial Colonization, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-31.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

This study will be conducted to assess the efficacy of caries excavation using the papain-based chemo-mechanical method (Brix 3000) in comparison to conventional rotary tools in the reduction of the bacterial population in occlusal carious cavities

Read the detailed description

Twenty-three patients who will fulfill the inclusion criteria will be enrolled to the study. For every patient two contra-lateral class I carious molars will be selected, so the total number of included molars will be 46 molars. One contra-lateral molar will be randomly assigned to the chemo-mechanical (Brix 3000) caries removal technique and the other will be assigned to the conventional rotary one. From every molar two dentin specimens will be collected (baseline and after excavation) with a total of 92 samples

02

Conditions studied

03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Class I carious lesions
  2. Lower molars
  3. Bilateral lesions
  4. 18 -50 years
  5. Males or Females (Both genders)
  6. Good oral hygiene
  7. Co-operative patients approving the trial

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy
  2. Systemic disease or severe medical complications
  3. Periodontal problem
  4. Mobile teeth, arrest caries and non-vital teeth
  5. Smokers
  6. Xerostomia
  7. Lack of compliance
  8. Not received antibiotic therapy since 1 month before sampling
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
2 participants (estimated)

Study arms

  • Experimental
    papain chemomechenical caries removal agent (brix 3000)

    papain chemomechenical caries removal agent (Birx 3000) and the exclusive Encapsulating Buffer Emulsifier (EBE) technology claim it has effective and selective proteolytic action

    Drug: Papain-based Chemo-mechanical caries removal agent · Device: conventional rotary

  • Placebo comparator
    conventional

    conventional 330 bur

    Drug: Papain-based Chemo-mechanical caries removal agent · Device: conventional rotary

Interventions

  • DrugPapain-based Chemo-mechanical caries removal agent

    Birx 3000 and the exclusive Encapsulating Buffer Emulsifier (EBE) technology claim it has effective and selective proteolytic action to remove collagen fiber in the carious tissue. It has an antibacterial and antifungal power, thus it has an antiseptic power at the tissue level .furthermore, this gel does not contain chloramines in its formula, which enhances its toxicological safety feature.

    Also known as: Brix 3000

  • Deviceconventional rotary

    traditional rotary method

    Also known as: round bur 330

05

What researchers measure

Primary outcomes

  1. bacterial count by Digital Colony Counter

    The number of colonies will be expressed as colony-forming units (CFU/ml) compared before and after removal caries using brix 3000 or rotary method

    Time frame: at the same visit (20 minutes)

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03408626
Lead sponsor
Cairo University
Responsible party
Laila Akmal Emad Eldien Elokaly (Teaching assistant, Cairo University) — Principal investigator
First posted
Jan 24, 2018
Start date
Mar 1, 2019 (estimated)
Primary completion
May 1, 2019 (estimated)
Completion
Jun 1, 2019 (estimated)
Last update
Jan 31, 2019

Study contacts

laila akml emad eldin elokaly, master
Contact
lailaelokaly15@gmail.com
01147604339 ext. 0223806159
laila akmal emad eldin elokaly, master
Contact
lailaelokaly15@gmail.com
01147604339 ext. 0223806159

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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