ClinicalTrials.gg
Not yet recruitingNCT06164509Updated Dec 11, 2023

Healing Potentiality of Trypsin and Alpha Chemo Trypsin in Mandibular Molars With Chronic Apical Abscess

A Phase 4 interventional study of Alphintern® , tablet, Amoun, Egypt in Mandibular Abscess, sponsored by Ain Shams University. Not yet recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-12-11.

Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Randomized
Sex
All
01

Study summary

assessment of healing potentiality of peri apical lesions using different doses of trypsin and alpha chemo trypsin in mandibular molars with chronic apical abscess

Read the detailed description

Owing to anti-inflammatory, anti-oedematous, fibrinolytic, anti-infective, and analgesic effects, trypsin:

chymotrypsin oral combination has emerged as a promising treatment of mandibular molars with chronic apical abscess. Trypsin chymotrypsin combination always showed a significant reduction in swelling and pain postoperatively.

Study procedures:

  1. According to inclusion and exclusion criteria; patients will be subjected to complete history taking, general and local "dental" examinations.
  2. Important dental symptoms will be assessed include bleeding, pain, malocclusion, new growths, numbness or paresthesias, and chewing problems.
  3. General information will be reported including use of alcohol or tobacco and systemic symptoms, such as fever and weight loss.
  4. A thorough inspection with good illumination, a tongue blade, gloves, and a gauze pad will be performed.
  5. Complete or partial dentures will be removed so that underlying soft tissues can be seen.
  6. A head-mounted light will be used. However, because the light cannot be precisely aligned on the axis of vision, it is difficult to avoid shadowing in narrow areas.
  7. Better illumination results will be performed with a head-mounted convex mirror.
  8. The temporomandibular joint (TMJ) will be assessed by looking for jaw deviation on opening and by palpating the head of the condyle anterior to the external auditory meatus.
  9. Examiner then place his little fingers into the external ear canals with the pads of the fingertips lightly pushing anteriorly while patients repeatedly open widely and then close.
  10. Preoperative preapical X-ray and CBCT will be done.
  11. Cases will be randomly divided into 3 groups; Group A will receive (Alphintern®, tablet, Amoun, Egypt), Group B will receive (Limitless Allzyme Max®, tablet, Eva, Egypt) Group C will not receive medication
  12. Medications will be taken three times daily for 7 days postoperative, after that all cases will be reexamined regarding healing rate, adverse effect and failure rate of medical treatment.
  13. Randomization, allocation and concealment: It will be done using computer generated randomization sheet. Sealed opaque packages will be given to a third person (nurse) who will assign the packages to study groups. Each patient will be invited to pull out a package. According to the number inside package, cases will be allocated to either group A, B or C according to a computer- generated random list.
  14. Postoperative preapical X-ray will be done at the end of the root canal treatment.
  15. Patient will be recalled after three months for preapical X-ray assessment.
  16. After six months patient will be recalled for preapical X-ray and CBCT to be done.
02

Conditions studied

  • Mandibular Abscess

Browse trials for

03

In context

Abscess

152 studies on the registry are indexed under Abscess; 22 are open to participants now.

This study's planned enrollment of 45 is below the median of 110 across 120 interventional studies indexed under Abscess.

Browse Abscess studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age: any age group.
  2. Both genders.
  3. Cases with mandibular molars with chronic apical abscess

Exclusion criteria

Exclusion Criteria:

  1. Patients with significant comorbidities like uncontrolled diabetes mellitus, hypertension, hepatic or renal disorders.
  2. patients.
  3. Patient with allergy from study medications.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
45 participants (estimated)

Study arms

  • Active comparator
    Alphintern

    Group A will receive (Alphintern® tablet, Amoun, Egypt),

    Drug: Alphintern® , tablet, Amoun, Egypt

  • Active comparator
    Alzyme Max

    Group B will receive (Limitless Allzyme Max®, tablet, Eva, Egypt)

    Drug: Alphintern® , tablet, Amoun, Egypt

  • No intervention
    Placebo

    Group C will not receive medication

Interventions

  • DrugAlphintern® , tablet, Amoun, Egypt

    Medications will be taken three times daily for 7 days postoperative, after that all cases will be reexamined regarding healing rate, adverse effect and failure rate of medical treatment.

    Also known as: Limitless Allzyme Max®, tablet, Eva, Egypt

06

What researchers measure

Primary outcomes

  1. Lesion size and bone Formation will be measured by cone-beam computed tomography

    cone-beam computed tomography will be done Before Drug is given and after 6 months

    Time frame: 6 months

07

Study locations

1 site
08

References and documents

Publications

  • Bouillaguet S, Manoil D, Girard M, Louis J, Gaia N, Leo S, Schrenzel J, Lazarevic V. Root Microbiota in Primary and Secondary Apical Periodontitis. Front Microbiol. 2018 Oct 9;9:2374. doi: 10.3389/fmicb.2018.02374. eCollection 2018. PubMed 30356779 ↗
  • Oberoi SS, Dhingra C, Sharma G, Sardana D. Antibiotics in dental practice: how justified are we. Int Dent J. 2015 Feb;65(1):4-10. doi: 10.1111/idj.12146. Epub 2014 Dec 16. PubMed 25510967 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06164509
Responsible party
Sponsor
First posted
Dec 11, 2023
Start date
Dec 20, 2023 (estimated)
Primary completion
Sep 20, 2024 (estimated)
Completion
Oct 20, 2025 (estimated)
Last update
Dec 11, 2023

Study contacts

Ghassan Salameh, Master
Contact
ghassan_salameh97@hotmail.com
01553569580 ext. 0020
Dr. Maram Obied, professor
Contact
maramobeid@dent.asu.edu.eg
01223562609 ext. 0020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion